CN212521755U

CN212521755U - Sleep physiological device and system

Info

Publication number: CN212521755U
Application number: CN202020155464.0U
Authority: CN
Inventors: 周常安
Original assignee: Individual
Current assignee: Individual
Priority date: 2019-05-14
Filing date: 2020-02-07
Publication date: 2021-02-12
Anticipated expiration: 2030-02-07
Also published as: CN111938612A; CN212521753U; CN111938577A; CN111938574A; CN111938576B; CN111938575A; CN213525123U; CN111938576A; CN212521748U; CN212521754U; CN213551768U; CN111938572A; CN111938573A

Abstract

The utility model provides a sleep physiology device and system, it sets up between a user's mouth nose through wearing the structure to utilize breathing airflow sensor to gain the sleep breathing airflow change during this user's sleep, with utilize and physiological sensor to gain sleep physiology information and/or sleep respiratory event during this user's sleep.

Description

Sleep physiological device and system

Technical Field

The present invention relates to a sleep physiology apparatus and system, and in particular, to a sleep physiology apparatus and system capable of assessing and improving sleep disordered breathing.

Background

Sleep Apnea (Sleep Apnea) is a Sleep disordered breathing that is generally of three types: obstructive Sleep Apnea (OSA), Central Sleep Apnea (CSA), and Mixed Sleep Apnea (MSA).

Obstructive Sleep Apnea (OSA) is characterized primarily by a reduction or cessation of respiratory airflow over a period of time during sleep due to a complete or partial obstruction of the upper airway, and is usually accompanied by a decrease in blood oxygen saturation (desaturation), OSA is a common sleep disordered breathing condition affecting about 25-40% of the middle-aged population.

Central Sleep Apnea (CSA) is caused by problems in the mechanism by which the brain drives the muscles to breathe, causing a short cessation of the neural drive of the respiratory muscles, and these transients, varying from 10 seconds to 2 to 3 minutes, may last the entire night, and central sleep apnea, similar to obstructive sleep apnea, causes a gradual apnea during sleep, resulting in a brief arousal (arousal) of the individual from sleep and a simultaneous restoration of normal respiratory function, and also similar to obstructive sleep apnea, central sleep apnea may cause cardiac arrhythmias, high blood pressure, heart disease, and heart failure.

Mixed Sleep Apnea (MSA) refers to a situation where both obstructive sleep apnea and central sleep apnea occur in mixture.

The Apnea Hypoxia Index (AHI) is an indicator of the severity of sleep Apnea, which combines the number of sleep apneas (apneas) and sleep hypopneas (hypopnes) to give an overall sleep Apnea severity score that allows simultaneous assessment of the number of sleep (breathing) interruptions and the degree of oxygen saturation (blood oxygen level), wherein the AHI is calculated by dividing the total number of sleep Apnea and hypopnea events by the number of sleep hours, typically the AHI value is divided by 5-15 mild per hour, 15-30 moderate per hour, and >30 severe per hour.

In addition to AHI, studies have shown that another important indicator for assessing or detecting sleep apnea is the Oxygen Desaturation Index (ODI), which refers to the number of times the blood Oxygen level decreases from baseline to some extent per hour during sleep, and in general, ODI is expressed in two ways, the number of times the Oxygen saturation decreases by 3% (ODI 3%) and the number of times the Oxygen saturation decreases by 4% (ODI 4%), unlike AHI, which also includes events that may cause sleep arousal (awaken) or arousal (arousal) but do not affect the Oxygen level, and studies have shown that ODI has some correlation with AHI and sleep apnea and is effective in diagnosing OSA.

In addition, hypoxia level is another index that can be used to assess the effects of sleep apnea, which is the ratio of the sum of the time when the blood oxygen saturation is less than 90% to the total time monitored. Because both AHI and ODI are calculated based on the occurrence frequency, the influence of continuous low blood oxygen level but not frequent blood oxygen fluctuation may not be reflected accurately, and the low oxygen level may make up for the deficiency, so there is a certain correlation between the low oxygen level and sleep apnea.

Most OSA patients develop more OSA events in the supine sleeping position because the upper airway is more susceptible to gravity collapse when supine, which is formally diagnosed in the literature as postural OSA (posional OSA) based on the difference between the AHI value when supine and not supine being greater than a certain threshold, e.g., POSA is a common definition in which the AHI value when supine is greater than twice the AHI value when not supine; from studies, the prevalence of POSA decreases with increasing severity of OSA, while 70% to 80% of POSA patients have mild to moderate severity of OSA, with asian mild OSA patients being classified as POSA patients up to 87%.

Another common sleep disordered breathing is snoring, which affects 20% -40% of the general population, and the noise-producing symptoms are caused by the vibration of soft tissues caused by the airflow of the upper respiratory tract during sleep, and OSA and severe snoring have been studied and proved to be highly related to various clinical symptoms, such as daytime sleepiness, melancholia, hypertension formation, ischemic heart disease, cerebrovascular disease and the like, wherein snoring is the most frequently accompanied symptom in OSA, and snoring is also widely considered as a precursor phenomenon of OSA, and the sleep posture also affects the severity of snoring symptoms based on the reason that the two causes are related to the physiological phenomenon of upper respiratory stenosis.

According to studies, it has been shown that, with the progress of upper airway stenosis, it is common that snoring related to a sleeping posture is first produced, and when it is more serious, snoring starts to easily occur even when the user is not lying on his back, and the snoring starts to progress to mild OSA, and the occurrence of snoring gradually decreases in relation to the sleeping posture, and further, the severity of OSA gradually changes from mild to moderate in relation to the sleeping posture, and finally to a severe situation that is less related to the sleeping posture.

Sleep Posture Training (SPT) is a method for treating OSA and snoring, and a new generation of posture Training devices has been developed in recent years, in which a posture sensor, such as an accelerometer, is installed on a central axis of a body, such as a neck, a chest or an abdomen, and when it is detected that a user is lying down, the user is prompted to change the sleeping posture to avoid lying down by generating a weak vibration alarm.

Such training is only of room for improvement, for example, due to different severity and individual physiological variability of OSA or snoring patients, providing a targeted training regimen and expected information about the training results before training if an evaluation function is provided; in addition, if information such as sleep and breathing can be provided during the sleep posture training period, the parameter setting of the device can be adjusted accordingly, so as to achieve the purpose of improving the training effect.

In addition to posture training, it is helpful to provide other training methods, such as non-posture sleep disordered breathing, or further strengthening based on posture training.

SUMMERY OF THE UTILITY MODEL

An object of the utility model is to provide a sleep physiology system, include: a housing; a control unit, accommodated in the housing, at least comprising a microcontroller/microprocessor; at least one respiratory airflow sensor electrically connected to the control unit; a physiological sensor electrically connected to the control unit; a communication module electrically connected to the control unit; a power module; and at least one wear structure for carrying the housing and positioning the housing and the at least one airflow sensor between a user's mouth and nose during a sleep session, wherein the at least one airflow sensor is configured to detect changes in the user's sleep airflow during the sleep session; and the physiological sensor is configured to acquire a sleep physiological information and/or a sleep respiratory event during the sleep of the user.

Another object of the present invention is to provide a physiological system for sleep, including: a sleep physiological apparatus comprising: a control unit at least comprising a microcontroller/microprocessor; a posture sensor electrically connected to the control unit for obtaining sleep posture related information of a user during a sleep period; the warning unit is electrically connected to the control unit and used for generating at least one warning for the user during the sleeping period; a communication module electrically connected to the control unit; a power module; and a wearing structure for arranging the sleeping physiological device on the user; and at least one port closure aid for placement near the user's mouth during the sleep session, wherein the control unit is configured to generate a drive signal, and the alert unit generates the at least one alert upon receiving the drive signal and provides the at least one alert to the user, wherein the drive signal is implemented to generate an alert behavior determined when the sleep posture-related information conforms to a preset posture range, at least upon comparing the sleep posture-related information to the preset posture range; and the at least one oral closure aid is configured to affect at least a portion of the upper airway of the user, and wherein the system further comprises an information providing interface for providing information relating to the sleep posture and/or information relating to the alert behavior to the user.

Another object of the present invention is to provide the sleep physiological apparatus in the sleep physiological system.

Another object of the present invention is to provide a physiological system for sleep, including: a sleep physiological apparatus comprising: a control unit at least comprising a microcontroller/microprocessor; a physiological sensor electrically connected to the control unit for acquiring sleep respiration physiological information of a user during a sleep period; a communication module electrically connected to the control unit; a power module; and a wearing structure for arranging the sleeping physiological device on the user; and at least one mouth closure aid for positioning adjacent the user's mouth during the sleep period; wherein the at least one oral closure aid is configured to affect at least a portion of the upper respiratory tract of the user to achieve an improvement in sleep disordered breathing of the user; and the sleep breathing physiological information is used for obtaining at least one sleep breathing event, and the system also comprises an information providing interface which is used for providing the at least one sleep breathing event to the user so as to make the user know the improved effect.

Drawings

FIG. 1 shows a schematic circuit diagram of a sleep physiology apparatus according to the present invention;

FIG. 2 shows a map of the physiological sensor placement location according to the present invention;

FIG. 3 shows a possible flow chart of a method of the present invention for improving sleep apnea;

FIG. 4 shows the main steps of the present invention for evaluating the relationship between sleeping posture and snoring;

FIG. 5 shows the main steps of the present invention for evaluating the relationship between sleep posture and sleep apnea/hypopnea;

FIG. 6 shows a PPG signal and its temporal characteristics;

FIG. 7 is a flow chart illustrating the performance of sleep posture training and/or sleep breathing physiological feedback training according to a preferred embodiment;

FIG. 8 is a schematic diagram of a physiological sensor implemented as a respiratory airflow sensor and disposed between the mouth and nose according to a preferred embodiment;

FIG. 9 is a schematic view of a sleeping physiology system according to the present invention, wherein the shell can be combined with different wearing structures according to different requirements;

FIGS. 10A-10B show a possible implementation of the oral closure aid; and

FIGS. 10C-10E show the possible implementation of the chin strap in combination with the headgear.

Description of the symbols in the drawings

200 crown area 201 forehead area

202 ear region 203 oronasal region

204 chin region 205 neck region

206 thoracic region 207 Abdominal region

208 arm region 209 finger region

210 head region 211 foot region

300 software program

301. 303, 304, 305, 307, 309, 312, 314, 315

317 historical sleep respiratory event baseline data

318 manual input by the user or practitioner

402. 405, 410, 415, 418, 425, 430, 440 steps

502. 505, 510, 515, 518, 525, 530, 540

801 shell 802 respiratory airflow sensor

901 chin strap 902 oral positioning fitting piece

903 head-wearing structure

Detailed Description

Fig. 1 illustrates a circuit schematic according to the present invention, wherein all components of the same device are connected to a control unit within the device, wherein the control unit comprises at least one microcontroller/microprocessor preloaded with programs to handle communication between hardware components, the control unit is capable of signal transmission between different hardware components and external applications/external devices connected to the device and/or system, and also allows the behavior of the device to be programmed in response to different operating conditions, and the microcontroller/microprocessor also utilizes an internal timer (not shown) to generate timestamps or timing differences or to control operations.

In addition, the control unit at least further includes an Analog Front End (AFE) circuit for obtaining physiological signals, so as to perform, for example, analog-to-digital conversion, amplification, filtering, and other various signal processing procedures known to those skilled in the art, which are all conventional and therefore not described in detail herein.

The system may comprise a light sensor, which in the present application refers to a sensor having both a light emitting source, e.g. an LED, and a light detector, e.g. a photodiode (photodiode), and which, as is well known, utilizes the principles of PPG (photoplethysmography), wherein light is emitted through the light emitting source into the body tissue, and the light detector receives light penetrating the blood vessel or reflected by the blood, after which a physiological signal of the blood is obtained by obtaining the change in volume of the light due to the blood, so the physiological signal of the blood obtained by the light sensor is generally referred to as PPG signal, wherein the PPG signal comprises a fast moving Component (AC Component), an AC Component, which reflects the pulse wave generated by the contraction of the myocardium transmitted through the artery, and a slow moving Component (DC Component), which reflects the slower change in the volume of the tissue blood, for example, Respiratory Effort (i.e., the dilatory action of the chest and abdomen during respiration), the effects of sympathetic and parasympathetic activity; in addition, physiological information such as relative blood vessel hardness and blood pressure can be obtained by analyzing the PPG signal; furthermore, physiological experiments show that the PPG pulse can generate harmonic resonance between each viscera and heart rate after frequency domain analysis, so that the pulse wave and heart rate harmonic resonance distribution can be applied to diagnosis of traditional Chinese medicine and monitoring of blood circulation of human body, for example, the liver and liver channels are related to the first harmonic of heart rate, the kidney and kidney channels are related to the second harmonic of heart rate, the spleen and spleen channels are related to the third harmonic of heart rate, the lung and lung channels are related to the fourth harmonic of heart rate, and the stomach and stomach channels are related to the fifth harmonic of heart rate.

Generally, the blood physiological information obtained may vary according to the type and number of the light sources and the light detectors included in the light sensor, for example, the light sensor may include at least one light source, such as an LED or a plurality of LEDs, preferably, green/infrared/red light, and at least one light detector to obtain the blood physiological information such as pulse rate/heart rate and respiration; wherein, when measuring the pulse rate/heart rate, green light and visible light with the wavelength below the green light, e.g., blue light, white light, is currently the main source of light used to measure heart rate, and is primarily focused on interpretation of the AC component portion, in addition, the effect of respiration on blood is that, when a person breathes, the pressure in the chest cavity (the so-called intrathoracic pressure) changes with each breath, wherein, when inhaling, the chest cavity will expand and the intrathoracic pressure will decrease, thereby drawing air into the lungs, during expiration, the intrathoracic pressure increases and forces air out of the lungs, and these changes in intrathoracic pressure also cause changes in the amount of blood returning to the heart through the veins and the amount of blood being pumped into the arteries by the heart, the change in this portion can be known by analyzing the DC component of the PPG signal, and in this context, the respiratory information obtained by analyzing the PPG waveform is referred to as low frequency respiratory behavior; furthermore, since the heart rate is controlled by the autonomic nerve, respiration affects the autonomic nervous system to cause a change in the heart beat, so-called Sinus Arrhythmia (RSA), which is generally accelerated during inspiration and slowed during expiration, so that the change in respiration can also be known by observing the heart rate, herein referred to as RSA respiration; therefore, the respiratory information obtained by the optical sensor is collectively referred to as respiratory behavior.

Alternatively, the optical sensor may also include at least two light sources, such as a plurality of LEDs, preferably green/infrared/red light, and at least one photodetector to obtain blood physiological information such as blood oxygen concentration (SPO2), pulse rate/heart rate, and respiration, wherein, when measuring blood oxygen concentration, two different wavelengths of light are required to be incident on the tissue, and the two wavelengths of light are absorbed differently by the oxygenated hemoglobin (HbO2) and the non-oxygenated hemoglobin (Hb) in the blood, and after receiving the light that has been transmitted and reflected, the result of comparing the two wavelengths can determine the blood oxygen concentration, therefore, the measurement of blood oxygen concentration usually has more restrictions on the position where the optical sensor is installed, and is better for the position where the light can actually be incident on the artery, such as the finger, palm, inner face, toe, sole, etc., and especially for measuring the blood oxygen concentration of infants, the two different wavelengths may be, for example, red light and infrared light, or green light with two wavelengths, such as 560nm and 577nm, respectively, so that the light source can be selected according to the requirement without limitation.

The wavelength ranges of the above-mentioned light sources are, for example, the red light wavelength is about 620nm to 750nm, the infrared light wavelength is about more than 750nm, and the green light wavelength is about 495nm to 580nm, and for measurement, the red light wavelength is usually 660nm, the infrared light wavelength is 895nm, 880nm, 905nm or 940nm, and the green light wavelength is about 510 nm to 560nm or 577nm, however, it should be noted that, in practical use, other light sources can be used according to different purposes, for example, when only the heart rate is to be obtained, other visible light sources with wavelength less than green light, that is, visible light with wavelength less than 580nm, for example, blue light, can be selected, and besides using a single light source with specific wavelength, a composite light source containing the wavelength, for example, white light, can also be used.

For example, the light sources may have three wavelengths simultaneously, for example, in one embodiment, the first light source is implemented as an infrared light source to generate light with a first wavelength, the second light source is implemented as a red light source to generate light with a second wavelength, and the third light source is implemented as a green light source to generate light with a third wavelength, wherein the infrared light source and the red light source are used for obtaining blood oxygen concentration, and the green light source is used for obtaining heart rate; alternatively, in another embodiment, the light of the first and second wavelengths is implemented as green light, and the light of the third wavelength is implemented as infrared light or red light, etc., two of which can be used to obtain the blood oxygen concentration, and the other wavelength to obtain the heart rate; alternatively, in another embodiment, the light of the first wavelength, the light of the second wavelength, and the light of the third wavelength are all implemented as green light, and the two green lights can be used to obtain the blood oxygen concentration, and the other green light can be used to obtain the heart rate. Therefore, there is no limitation.

Furthermore, when the heart rate is obtained, in order to eliminate noise, such as environmental noise, noise generated by body movement during wearing, etc., two or more light sources (and wavelengths are not limited, green light may be used, and light sources with other wavelengths may also be used) may be provided, and the purpose of eliminating noise is achieved by performing digital signal processing, such as Adaptive Filter (Adaptive Filter) or calculation by subtracting each other, between PPG signals obtained by different light sources, so that the present invention is not limited.

The system may comprise a posture sensor, typically an accelerometer, preferably a three-axis (MEMS) accelerometer, which defines the posture of the device in three dimensions and is directly related to the sleeping posture of the user, wherein the accelerometer returns acceleration values measured in all three dimensions x, y, z, from which a number of other sleeping information may be derived in addition to the sleeping posture, such as physical activity (actigraph), movement, standing/lying posture changes, etc., wherein further information about the sleeping phase/state may be obtained by analyzing the physical activity during sleep; in addition, other types of accelerometers may be used, such as gyroscopes, magnetometers, and the like.

The system may include a microphone that feeds back the frequency and amplitude of the detected sounds, and the sounds in sleep, such as snoring or breathing, may be detected using an appropriate filtering design of the sound transducer (acoustic transducer).

The system may include a snore detector, which may be implemented to detect sound through the microphone, or to detect body cavity vibration caused by snoring, and may use an accelerometer, a piezoelectric vibration sensor, or the like, and the detected positions include, for example, the trunk, the neck, the head, the ears, and the like, wherein the trunk and the head are better locations to obtain, and particularly the nasal cavity, the throat, the chest, and the like, are particularly capable of well transmitting the vibration caused by snoring, which is an advantageous choice; therefore, the accelerometer as a posture sensor can be used to acquire information related to snoring at the same time, and is more convenient to use. Furthermore, the information related to snoring, such as intensity, duration, frequency, etc., is obtained from the original vibration signal by using appropriate filtering design and known techniques, and since the types and obtaining manners of the signals obtained by different sensors are different, different appropriate filtering designs should be correspondingly adopted.

The system may include a temperature sensor to detect device temperature, ambient temperature, or body temperature to provide further physiological information to the user during sleep.

The system may include a respiratory airflow sensor, such as a thermistor, thermocouple, or respiratory airflow tube, disposed between the mouth and nose to obtain changes in respiratory airflow, wherein the thermistor and thermocouple may be selectively disposed adjacent to the nostrils, or alternatively, three detection points may be disposed adjacent to the nostrils and the mouth.

The system may include an accelerometer that may be positioned on the torso to obtain acceleration and deceleration due to fluctuations in the chest and/or abdomen during breathing; the method can also be used to detect the blood vessel pulsation generated by the blood pulsation to obtain the heart rate, and the obtaining position is not limited, for example, the head, the chest, the upper limbs, etc. are all available positions.

The system may include at least two impedance detection electrodes disposed on the torso to obtain impedance changes caused by breathing.

The system may include a piezoelectric motion sensor mounted on the torso that receives signals from the force exerted on the piezoelectric motion sensor by breathing, typically in the form of a band around the torso, or partially covering the torso.

The system may include RIP (Respiratory Inductance mapping) sensors mounted on the torso to acquire chest and/or abdomen distension and contraction caused by breathing, typically in the form of a belt around the torso.

The system can comprise at least two electroencephalogram electrodes, at least two eye electrodes and/or at least two myoelectricity electrodes, for example, two electroencephalogram electrodes arranged on the head and/or ears, and/or two eye electrodes arranged near the forehead and eyes, and/or two myoelectricity electrodes arranged on the body, so as to obtain electroencephalogram signals, electro-oculogram signals and/or myoelectricity signals, and by analyzing the electroencephalogram signals, the electro-oculogram signals and/or the myoelectricity signals, the sleep state/stage, sleep cycle and the like during sleep can be known, which is helpful for understanding the sleep quality.

It should be noted that, generally, when acquiring electrophysiological signals, a signal acquisition electrode and a ground electrode are often disposed, wherein the signal acquisition electrode is used for acquiring electrophysiological signals, and the ground electrode is used for removing background noise, and all electrodes described herein belong to signal acquisition electrodes, however, to avoid over-redundancy, in the following description, "electrode" is used to represent "signal acquisition electrode", and the disposition of the ground electrode is generally selectively disposed according to actual requirements, so that it is omitted herein for brevity.

The information about sleep stages/states can be obtained by analyzing the heart rate, for example, since there is a certain relationship between the change of the heart rate during sleep and the sleep stages, for example, the change of the heart rate during deep sleep and shallow sleep is different, it can be known by observing the distribution of the heart rate during sleep, and it can also be obtained by other common analysis methods, for example, HRV analysis can know the activity of autonomic nerves, which are also related to the sleep stages, Hilbert-Huang transform (HHT) and other applicable methods can be used to analyze the change of the heart rate, and the information about sleep stages can be determined by observing the heart rate and the body movement at the same time.

The system may include an alert unit. Many types of alerts are available, including: audible, visual, tactile, e.g., sound, flashing lights, electrical stimulation, vibration, etc., or any other alert that may be applied to notify the user, wherein the use of a vibratory alert is preferred to provide an alert that is more comfortable and does not disturb the user's sleep, although alternatively, in some environments, the alert unit may use a speaker or headphones for audible alert (air or bone conduction), or LEDs for visual alert.

The system may include an information providing interface, preferably an LCD or LED display assembly, to provide information to the user, such as, without limitation, physiological information, statistical information, analytical results, stored events, operating modes, alert content, process, battery status, etc.

The system may include a data storage unit, preferably a memory, such as an internal flash memory, or a removable memory disk, to store the measured physiological information.

The system may include at least one communication module, which may be implemented as a wireless communication module, such as bluetooth, BLE, Zigbee, WiFi, RF or other communication protocols, or a wired communication module, such as a USB interface, a UART interface, for communicating in the system and/or for communicating with an external device, wherein the external device may include, but is not limited to, an intelligent device, such as a smart phone, a smart bracelet, smart glasses, a smart headset, etc., a tablet computer, a notebook computer, a personal computer, that is, a device disposed on or near a person, and the communication enables information to be exchanged between the devices, and also enables operations such as information feedback, remote control, and monitoring. The smart device is an open platform device that can control its behavior by using a loader and/or a preloaded program, and may have various possibilities.

The system may include a power module, such as a button cell, alkaline battery, or rechargeable lithium battery, and the system may also have a charging module, such as an inductive charging circuit, or be charged through, optionally, a USB port or pogo pin.

Next, please refer to fig. 2, which shows the positions where the various physiological sensors and the alarm unit can be normally set during sleep, and the obtained sleep physiological information and the detailed setting details are as follows.

A sleep position (sleep position) obtained by a position sensor, the position obtained being around a medial axis of a body, comprising: the head region 200, the forehead region 201, the ear region 202, the nose and mouth region 203, the chin region 204, the neck region 205, the chest region 206, and the abdomen region 207 may be disposed on any body surface surrounding the central axis of the body, such as the front, the back, etc., as long as the sleeping posture can be obtained by conversion, wherein the trunk and the neck above the trunk are most representative.

The blood oxygen concentration variation is obtained by the optical sensor, and the position obtaining comprises the following steps: forehead region 201, ear region 202, mouth-nose region 203, arm region 208, finger region 209, and foot region 211.

The heart rate can be obtained by using an optical sensor, and the position is not limited, wherein the finger area 209, the arm area 208, the ear area 202, the head area 210, and the like are commonly used, but any position of the body can be used, and in addition, the blood vessel vibration generated by the blood pulsation can be detected by using an accelerometer with high sensitivity, so as to obtain the heart rate, and the obtaining position is also not limited, for example, the head, the chest, the upper limbs, and the like can be obtained.

Respiratory Effort (respiration efficiency), i.e., respiration-induced chest and/or abdominal activity, can be obtained using accelerometers, piezoelectric motion sensors, RIP sensors, or impedance detection electrodes, and the location obtained includes: a chest region 206 and an abdomen region 207.

The respiratory behavior is a general term for respiratory information obtained by using an optical sensor, and as mentioned above, the respiratory behavior is divided into two types, where the low frequency respiratory behavior is respiratory information obtained by analyzing a PPG waveform, and the RSA respiratory behavior is respiratory information obtained by calculating a heart rate, and the positions of the respiratory behavior are not limited, and among them, the finger region 209, the arm region 208, the ear region 202, and the head region 210 are commonly used, but any position of the body may be used.

The respiratory airflow change is acquired by a respiratory airflow sensor (e.g., a thermistor, a thermocouple, an airflow tube, etc.), and the acquired position is the oronasal region 203.

The information related to snoring (snoring sound) and the breathing sound are obtained by the microphone, and the obtained position is not limited, and the information related to snoring and the breathing sound can also be obtained from the outside of the body, such as a mobile phone.

The snoring-related information (body cavity vibration) is acquired by an accelerometer or a piezoelectric vibration sensor, and the acquiring position includes: a head region 210, a neck region 205, a chest region 206, and an abdomen region 207.

The electroencephalogram signal is acquired by the electroencephalogram electrodes, and the acquired position is the head region 210.

The electro-ocular signals are obtained by electro-ocular electrodes, and the obtained position is the forehead area 201.

The myoelectric signals are obtained by myoelectric electrodes at various positions, such as the forehead region 201 and the chin region 204.

The physical activity is obtained by an accelerometer, and the obtaining position is not limited.

In the sleep stage, the position can be obtained by using the optical sensor and/or the acceleration, the position is not limited, the position can also be obtained by using an electroencephalogram electrode, an electrooculogram electrode and/or an electromyogram electrode, and the position is mainly obtained by the head; furthermore, by analyzing the distribution of sleep stages, such as the ratio of deep sleep and light sleep to the total sleep time, the sleep quality can be known.

Furthermore, the warning unit providing the vibration warning may be disposed at any position where the body can sense the vibration, and the warning unit providing the sound warning may be preferably disposed near the ear, for example, when the air conduction sound warning is employed, it is preferable to be disposed near the ear canal and the ear canal orifice, and when the bone conduction sound warning is employed, it may be disposed in a wide range, except near the ear, the entire skull may be disposed, preferably, there is no hair, and the warning may be provided in not only a single form but also in more than two forms, for example, the vibration and the sound may be provided at the same time. In addition, the vibration warning mode can be selected differently, for example, different vibration combinations can be combined according to various changes of intensity, frequency, duration and the like, so that the user can select a proper vibration mode and can also help to avoid the phenomenon of feeling fatigue.

It is noted that the ear region 202 includes the inner and back of the pinna, the ear canal, and the head near the ear, the arm region 208 includes the upper arm, forearm, and wrist, and the neck region 205 includes the front and back of the neck.

In addition, when the device is installed, for example, when the housing containing the physiological sensor is installed on the body surface, various suitable wearing structures can be used, for example, a ring body and a belt body can be used, for example, the ring body can encircle the head, the arms, the fingers, the neck, the trunk and the like; using an adhesion structure, for example, adhering to any position on the forehead, trunk, etc. where adhesion can be performed; using (mechanical or magnetic) clamps, for example, to clamp a part of the body, such as a finger, an ear, etc., or to clamp on an object placed on the body surface, such as a garment, a band around the body, etc.; and/or by using a hanging member, for example, hung on the auricle, and the like, and thus, is not limited to a particular type of wearing structure.

As can be seen from the above, even if the same kind of physiological information is used, it is possible to obtain the same physiological information by using different kinds of physiological sensors and selecting different body regions, and further, it is possible to select two or more kinds of physiological sensors and/or obtain two or more kinds of physiological information at the same time and/or to set the same in two or more body regions.

In addition to obtaining the blood oxygen concentration for calculating ODI values, hypoxia levels, and other data known to those skilled in the art, the PPG signal obtained by the light sensor may also be varied with respect to the occurrence of sleep apnea/hypopnea, and may be used as a basis for determining whether sleep apnea/hypopnea is occurring.

The occurrence of obstructive sleep apnea causes a relative increase in the amplitude of the Pulse Wave Amplitude (PWA) of the bradycardia and PPG signals, as well as a rapid increase in heart rate and strong vasoconstriction that occurs immediately after the end of the respiratory obstruction, which is referred to herein as a heart rate variability sleep-breathing event, and according to studies, it has been reported that for patients with sleep-disordered breathing, the sleep-breathing event and arousal cause more variability in the PWA and/or Pulse Area (PA) than the Peak-to-Peak interval (PPI) of the Heart Rate (HR)/Pulse.

As shown in fig. 6, PPI is defined as the time difference between two consecutive peaks in the PPG signal. First, the peak (peak. amp) of each cycle of the PPG signal is detected and the time stamps of all peak. amp points are stored in an array buffer, the PPI is calculated as the time difference between consecutive peak. amp points, a reasonable range of PPI values can be set for accurate results, e.g., PPI <0.5 seconds (>120 times/min) or PPI >1.5 seconds (<40 times/min) is considered abnormal and removed.

PWA is defined as the difference between the peak amplitude (peak. amp) and the trough amplitude (valley. amp), which are the maximum and minimum amplitude points per PPG cycle. First, all peak and valley amp points are detected as local maxima and minima of the PPG signal, and if a missing peak amp point occurs, the immediately following valley amp point is also discarded, and finally, PWA is calculated by subtracting valley amp from the immediately preceding peak amp. Since the peak and valley amp points are only detected in pairs, and are discarded otherwise, there will be no error in the PWA values due to one of them not being seen, and furthermore if there are any anomalous peak amp points, they are excluded by the filtering procedure mentioned in the PPI feature extraction.

PA represents a triangular area consisting of one peak. Similar to the extraction of the PWA features, all peak and valley amp points are detected as local maxima and minima in the PPG signal, and since the time stamp (i.e., the number of samples per point) is also recorded, the pulse area can be calculated from each pulse waveform.

The respiration signal RIIV (respiration Induced Intensity Variation), which is caused by respiration-synchronized blood volume changes, can be filtered from the PPG signal by a band-pass filter, such as a 0.13-0.48Hz 16th Bessel filter, which suppresses heart-related changes in the PPG signal and frequencies below the respiration rate, such as sympathetic activity and reflex changes in response to efferent vagal activity.

Therefore, in order to detect sleep apnea/hypopnea events and their onset (onset), various sleep apnea related information such as PPI, PWA, PA, RIIV from the light sensor derived from the PPG waveform may also be used as indicators.

In light of the above, the present application term is defined as follows:

sleep physiological information, comprising at least: sleep posture related information, sleep stage, sleep body activity, blood oxygen concentration, heart rate, breathing action, breathing air flow variation, breathing behavior, breathing sound variation, snoring related information, electroencephalogram signals, electrooculogram signals, and electromyogram signals.

Sleep breathing physiological information, comprising at least: blood oxygen concentration, heart rate, respiratory action, respiratory airflow change, respiratory behavior, respiratory sound change and snore related information.

A sleep respiratory event comprising: blood physiology sleep respiratory events (oxygen desaturation events, low oxygen level events, heart rate variability sleep respiratory events), snoring events, sleep apnea events, and sleep hypopnea events.

Next, the present invention provides a sleep breathing physiological feedback training according to a sleep breathing event, and fig. 3 shows a schematic flow chart for improving sleep apnea by using the sleep breathing physiological feedback training.

The method is mainly implemented by monitoring the sleep respiratory physiological information by using a software program, and when the sleep respiratory physiological information of a patient meets a preset condition during sleep, triggering an alarm unit to generate an alarm, such as any type of alarm of auditory sensation, tactile sensation, visual sensation, and the like, so that a user is partially awakened (awaken) or awakened (arousal) enough to interrupt a sleep respiratory event, thereby achieving the effect of preventing sleep apnea/hypopnea, wherein if the arousal is not detected, for example, according to the obtained sleep respiratory physiological information, the intensity of the alarm is increased when the next sleep apnea/hypopnea occurs.

The method of monitoring sleep apnea events and their initiation and periodically and continuously waking the patient briefly to sleep is a feedback exercise for preventing sleep apnea/hypopnea so that the user, when using the system, experiences repeated sleep apnea/hypopnea events, will instinctively learn to go back to sleep after several deep breaths have occurred. According to research and experimentation, such a conditioned response to an alert may be effective to reduce or eliminate sleep apnea/hypopnea after a period of use.

Here, the preset conditions may be changed according to the acquired physiological information of sleep breathing, such as preset blood oxygen concentration change, preset heart rate change, etc., which will be described in more detail in different embodiments, and it is preferable that the preset values are used at the beginning of the setting process and then adjusted for each user, for example, historical data collected by the physiological sensor may be used to help determine the preset conditions suitable for the user, and the dynamic adjustment is helpful to reduce the occurrence rate of false alarm and improve the accuracy of sleep event detection, which is a more advanced method.

The software program can be preloaded in the wearable device for obtaining sleep physiological information, or can be preloaded in an external device, such as a personal computer or an intelligent wearable device, without limitation.

The implementation process starts at step 301, and then at step 303, a preset condition is set, wherein the preset condition is a value for which an alarm is activated, and in some embodiments, the preset condition may be automatically set in the software program 300 or set by using a preset value; alternatively, these values may be determined by the user or practitioner and manually entered 318, and may be changed based on user-specific information. The threshold condition/value of the preset condition 303 may include, but is not limited to, various sleep respiration physiological information and sleep respiration event related information, such as blood oxygen level of the user, heart rate of the user, ODI, pulse wave amplitude, etc.

In the learning mode, the software routine 300 begins signal sampling 305, which is collected by the wearable device and transmitted to the software routine 300 using data transmission techniques known to those skilled in the art, and then, in step 313, the software routine 300 collects sampled data including sleep breathing physiological information, wherein the sampled data is stored in a memory or database using techniques known to those skilled in the art, and identifies sleep breathing events in step 314, for example, by analyzing information related to the sleep breathing events.

At step 315, software program 300 compares the identified sleep respiratory events to historical sleep respiratory event baseline data 317. In some embodiments, the historical sleep respiratory event baseline data 317 may include sleep respiratory physiological information, such as heart rate values and blood oxygen level values provided by the guidance of a medical professional, etc., and the historical respiratory event baseline data 317 may also provide PPG waveforms, heart rate variability, blood oxygen values, and other medical data indicative of the user's sleep respiratory event and its onset; in some embodiments, historical sleep respiratory event baseline data 317 may be obtained from historical readings of the user, a trending source of sleep respiratory event baseline data (e.g., MIT-BIH polysomnography database), or statistically derived data, among others. At step 315, the sampled data is compared to historical sleep breathing event baseline data 317 to determine if false alarms occurred within a specified time period, if false alarms are found, then preset conditions are adjusted at step 315 to ensure that sleep breathing events are correctly detected, if no false alarms are detected, or if only a few false alarms are detected within a preset range acceptable to the software program 300 or user, then the preset conditions are not adjusted at step 315 and the process proceeds to the done state 320.

In the training mode, please return to step 305, in which the software program 300 performs signal sampling, then, in step 307, signal processing and corresponding algorithms are performed to extract the sleep respiration physiological information and related values from the sampled signals, after step 307, the software program 300 continuously checks in step 309, and by comparing the result obtained in step 307 with the preset conditions set in step 303, and determines whether there is a match with the predetermined condition, if there is no match with the predetermined condition in step 309, the signal sampling continues, and no further processing is performed, if there is a match with the preset conditions in step 309, an alert action is determined to initiate generation of the alert 312, where, this alert will allow the user to wake up briefly, and then the user will take several deep breaths and go back to sleep, thus stopping the apnea/hypopnea condition. The process of monitoring, alerting (and adjusting the preset conditions) continues throughout the training mode, and as a result the frequency and number of sleep apnea/hypopnea events gradually decrease.

The learning mode and the training mode may be dynamically switched automatically, or manually set by the user, and may be performed at the same night or different nights to optimize the treatment effect, without limitation.

Next, the system provides content regarding the assessment and improvement of postural sleep disordered breathing.

Referring to FIG. 4, a flow chart illustrates the main steps of using the system to evaluate the relationship between sleep posture and snoring and provides a related training method. In step 402, the device is placed on a user via a wearing structure.

In step 405, when the device wearing setting is completed, the control unit starts data collection to obtain sleep posture related information during the sleep period of the user, wherein the collected data may be transmitted to an external device through the wireless communication module, or may be stored in a memory of the wearable device and then transmitted to the external device for subsequent analysis, and then please refer to step 410, in which the snore event related information is collected, and the available sensors include, but are not limited to, a microphone, a piezoelectric vibration sensor, and an accelerometer, which may be disposed on the wearable device, or may also be disposed on the external device, such as a smart phone, without limitation.

Next, in step 415, the sleep posture related information and the snoring event related information are combined with each other, and the correlation between them is calculated by a software program, for example, the lying-on-back snoring index is defined as the number of snoring events per hour in the lying-on-back posture, the non-lying-on-back snoring index is defined as the number of snoring events per hour in the lying-on-back posture, and the snoring index is defined as the lying-on-back snoring index + the non-lying-snoring index, and further, the lying-on-back snorer (sitting-dependent snorer) is defined as the lying-on-back snoring index higher than the non-lying-snoring index. At 418, a predetermined threshold is compared to, for example, a ratio of the snore index on back and the snore index on non-back, or other value, and if the threshold is exceeded, the user is identified as a postural snorer (positional snorer) and then Sleep Position Training (SPT) can be performed at 425, otherwise the user can perform Sleep breathing physiological feedback Training based on the snore event at 430; or alternatively, in case of a high posture dependency (high-non-supine snore index) accompanied by a high non-supine snore index, the user may combine both posture training during supine posture and sleep breathing physiological feedback training based on snore events during non-supine posture. On the other hand, if a high snore index is accompanied by a lower posture dependency, the user can check whether it is a postural sleep apnea (POSA) through step 440, since according to the study, the higher the snore index of the user, the more often it is found to be posture independent, which means a more severe upper airway obstruction that may lead to OSA symptoms.

Referring next to FIG. 5, a flow chart illustrates the main steps of using the system to assess the relationship between sleep posture and sleep breathing events, which may or may not include snoring events, and a corresponding training method is provided. In step 502, the device is placed on a user via a wearing structure.

When the device wearing setting is completed, the control unit starts data collection to acquire sleep posture related information during the user's sleep in step 505, the collected data may be transmitted to the external device through the wireless communication module, or may be stored in the memory of the wearable device and then transmitted to the external device for subsequent analysis, and then, referring to step 510, in this step, the collection of physiological information of sleep breathing is performed, and sensors that can be used include, but are not limited to, optical sensors, accelerometers, piezoelectric vibration sensors, piezoelectric motion sensors, impedance sensing electrodes, RIP sensors, respiratory airflow sensors, microphones, and the like, according to the difference of the obtained signals, the sensor can be arranged on the wearable device or can be arranged on an external device, such as a smart phone, without limitation.

Next, in step 515, the sleep posture related information and the sleep respiration physiological information are combined with each other to calculate the correlation between them by a software program, for example, the supine sleep respiration event index is defined as the number of sleep respiration events per hour in the supine posture, the non-supine sleep respiration event index is defined as the number of sleep respiration events per hour in the non-supine posture, and the sleep respiration event index is the supine sleep respiration event index + the non-supine sleep respiration event index, and the user of the postural sleep respiration event is defined as the supine sleep respiration event index higher than the non-supine sleep respiration event index. At 518, a predetermined threshold is compared to, for example, a ratio of the index of supine sleep breathing events to the index of non-supine sleep breathing events, or other value, and if the threshold is exceeded, the user is identified as a postural sleep breathing event user and then Sleep Posture Training (SPT) is performed at 525, otherwise the user may perform sleep breathing physiological feedback training based on sleep breathing events at 530; alternatively, if the high position dependency (high-non-supination sleep respiratory event index) is accompanied by a high non-supination sleep respiratory event index, the user may combine both posture training during a supination posture and sleep respiratory physiological feedback training based on sleep respiratory events during a non-supination posture.

Wherein the posture training is performed by activating an alarm, such as vibration or sound, when the sleep posture is detected to be in a predetermined posture range, such as lying on back, for a period of time (e.g., 5 seconds to 10 seconds), and the alarm is gradually increased/increased in intensity until the sleep posture is detected to be out of the predetermined posture range, such as changing to a different sleep posture or a non-lying on back posture, the alarm is immediately stopped, and if no posture change is detected after a predetermined period (e.g., adjustable 10 seconds to 60 seconds), the alarm is suspended and restarted after a period of time (e.g., adjustable minutes); in some embodiments, the frequency/duration of the alert will be very short initially and gradually increase until the user no longer assumes the supine position; there are several repetitions (e.g., 6) of the inter-alert interval (e.g., 2 seconds) regardless of the intensity of the alert.

The preset posture range may be set according to actual requirements, for example, the preset posture range may be changed according to different definitions of the lying posture, for example, when the accelerometer is disposed on the torso, the included angle between the normal of the torso plane and the normal of the bed surface may be set to be within a range of plus or minus 30 degrees, or when the accelerometer is disposed on the forehead, the included angle between the normal of the forehead plane and the normal of the bed surface may be set to be within a range of plus or minus 45 degrees due to more movements of the head, or when the accelerometer is disposed on the neck, the same set range as the head may be set. Therefore, there are various options without limitation.

In addition, the posture training performed for snoring is similar to the above situation, but the reason for providing the warning is whether snoring is detected or not, which is not described in detail.

The warning is provided by the control unit being configured to generate a driving signal, and the warning unit generating at least one warning after receiving the driving signal and providing the at least one warning to the user to achieve the purpose of sleep posture training and/or sleep breathing physiological feedback training, wherein the driving signal is generated by a warning behavior determined at least according to a comparison between the sleep posture related information and a preset posture range, when the sleep posture related information conforms to the preset posture range, and/or according to a comparison between the sleep breathing physiological information and a preset condition, and when the at least one sleep breathing physiological information conforms to the preset condition. The details and how to provide the warning are further described in the following embodiments.

It should be noted that, the above-mentioned warning unit, regardless of the type of the generated warning, such as vibration or sound, may be implemented in various ways, for example, it may be installed in the wearable device for acquiring the sleep physiological information, or in another wearable device, or in an external device, so there is no limitation.

In addition, the provision of the alert is preferably performed after confirming that the user has fallen asleep, in a manner that is least disruptive to sleep, and to this end, in a preferred embodiment, the present invention is directed to utilizing the physiological information of sleep detection to know whether the user has fallen asleep, and the system enters an alert generating state after falling asleep and begins to provide sleep posture training and/or sleep breathing physiological feedback training.

When the system is executed, the sleep physiological information acquired by the physiological sensor is compared with a preset condition to determine whether the user accords with a preset sleep breathing condition, wherein the preset sleep breathing condition adopts a physiological condition which can occur after the user falls asleep, such as whether an oxygen desaturation event, a hypoxia level event, a heart rate change sleep breathing event, a snoring event, a sleep apnea event, a sleep hypopnea event, a specific change in breathing and/or a specific change in heart rate occur.

For example, snoring can be detected as a reference, for example, by a microphone or accelerometer, and particularly snoring is almost always first detected before obstructive sleep apnea occurs, which is an advantageous point in time to follow for performing sleep posture training or performing sleep breathing physiological feedback training; the sleep-related information can also be obtained by analyzing the heart rate, for example, the heart rate may have a specific change while sleeping, or the state of the body can be known by obtaining HRV (heart rate variability) according to the heart rate calculation; whether to fall asleep can also be known by analyzing respiration, for example, the respiration rate becomes slow after sleeping, and the like; whether to fall asleep can also be known by knowing the sleep stage, for example by analyzing physical activity measured by an accelerometer (activity), and/or heart rate acquired by a light sensor; alternatively, the detection of the occurrence of a sleep breathing event can also be taken as a baseline for having fallen asleep. Therefore, there are many possibilities in selecting the physiological sensor, and all the above physiological sensors capable of acquiring sleep physiological information can be used without limitation.

In addition, the position of the physiological sensor for obtaining the physiological information for determining whether the system enters the alarm generating state may also be different according to the actual requirement, and the physiological sensor may be implemented by directly using the physiological sensor used for performing the training process, or may be a physiological sensor additionally installed, for example, an accelerometer, a light sensor, a microphone, etc. installed in a device worn on the body may be used, or a wearing device may be additionally installed, a microphone installed in an external device beside the bed may be used, or an accelerometer installed on the mattress may be used, which is a possible option.

Further, as shown in the flowchart of fig. 7, the sleep posture training and the sleep respiration physiological feedback training can be performed together in the same sleep period. In this case, the sleep posture related information and the sleep respiration physiological information can be obtained in the same sleep period by providing the posture sensor and at least one physiological sensor, wherein the at least one physiological sensor may be, for example, a light sensor, a microphone, an accelerometer, a piezoelectric motion sensor, a piezoelectric vibration sensor, an impedance detection electrode, an RIP sensor, and/or a respiration airflow sensor, without limitation, according to the difference of the sleep respiration physiological information to be obtained and the selection of the setting position, and particularly, when the accelerometer is selected as the physiological sensor, it may also be simultaneously used as the posture sensor.

Then, the sleep respiration physiological information analysis program is utilized to compare the sleep respiration physiological information with the preset condition, can determine the sleep breathing event of the user, and utilize the sleep posture analysis program to compare the sleep posture related information with the preset posture range, wherein, when the sleep posture related information accords with the preset posture range, a first warning condition combination is provided, and providing a second warning condition combination when the sleep posture related information exceeds the preset posture range, the alarm decision procedure decides the alarm behavior according to different alarm condition combinations, therefore, the control unit generates a driving signal according to the alarm behavior, the warning unit generates at least one warning after receiving the driving signal so as to achieve the effect of influencing the sleeping posture of the user and/or influencing the sleeping respiratory state of the user.

Wherein the first alert condition set at least includes at least one of a time range condition and a sleep breathing event condition, for example, the time range condition may be implemented based on an absolute time, for example, 1 am; can also be implemented on a specific physiological condition basis, e.g., 1 hour after having laid down, having fallen asleep, or other various physiological conditions; the delay time can also be implemented, for example, after the device is started for 1 hour, so that whether the alarm is provided under the condition of meeting the preset posture range can be selected according to the actual time requirement, which is beneficial to providing more comfortable use experience.

The second warning condition combination at least includes the time range condition and the sleep breathing event condition, for example, when the sleep posture related information exceeds a preset posture range, for example, in a non-lying state, the most main condition for generating the warning is the occurrence of the sleep breathing event, and as mentioned above, the time for performing the sleep breathing physiological feedback training can be selected, for example, an absolute time is used as a reference, or a specific physiological condition is used as a reference, or a delay time is set.

Furthermore, other conditions, such as warning intensity condition, warning frequency condition, etc., can be added to provide a warning with weaker intensity when the user just falls asleep, and the intensity is increased after a period of time, so that the user can perform training more in line with the requirements and feel less disturbed by the provision of the combination of the warning conditions.

Furthermore, since the sleep posture is changed at any time during the sleep, the first warning condition combination and the second warning condition combination are dynamically applied, and the application order is not limited.

The utility model discloses in the application system, different according to the function of carrying out, can have various software programs correspondingly, include, but not limited to, sleep physiology information analysis program, sleep breathing incident analysis program, warning decision procedure etc. to obtain various physiology information according to the physiology signal that physiological sensor obtained, and be not restricted, various software programs can be according to the difference of actual demand and implementation mode and preload in different devices.

According to the above-mentioned sleep breathing physiological feedback training based on the sleep breathing physiological information (fig. 3), and the sleep breathing disorder detection and training based on the sleep posture (fig. 4 and fig. 5), in combination with various possible installation positions of the physiological sensor (as shown in fig. 2) capable of obtaining the related physiological signals, the present invention is not limited to the following various implementation possibilities, and therefore, the above-mentioned various training contents and combinations can be realized by any suitable embodiments described below, and will not be repeated.

The present invention is directed to evaluating the relationship between a user's sleep posture and sleep disordered breathing, and further to how to improve postural sleep disordered breathing.

The main idea is to acquire sleep physiological information capable of determining various sleep respiratory events and the relationship between the sleep respiratory events and the sleep posture in the simplest manner without changing the installation position.

One implementation of the sleep physiology system may be that the sleep physiology system comprises a shell, a wearing structure for placing the shell on a user, a control unit at least comprising a microcontroller/processor, a communication module, and a power module, and in terms of obtaining sleep physiology information, the sleep physiology information is obtained by a posture sensor and a physiology sensor electrically connected to the control unit, wherein the posture sensor is used for obtaining sleep posture related information of the user during sleep, and the physiology sensor is used for obtaining snoring related information during sleep, wherein, in particular, the physiology sensor adopts an accelerometer to obtain snoring related information by detecting body cavity vibration generated by snoring as an optimal position for obtaining sleep posture related information by using a trunk and a neck above the trunk, especially, when the snore is detected by using the accelerometer, the snore can be detected normally without being influenced by the external environment sound even if the snore is shielded by clothes or cotton, and the accelerometer is a very convenient choice.

Accordingly, the information related to the sleeping posture of snoring can be obtained by the obtained information related to the sleeping posture and the information related to snoring, which is very useful information for the user, especially, whether snoring occurs can be known only by simply arranging a single device on the trunk or the neck, and the relationship between the occurrence of snoring and the sleeping posture can be further known, for example, the distribution and the proportion of snoring in different sleeping postures are simple and effective choices, and the method is particularly suitable for detecting at home. Here, particularly, the physiological sensor implemented as an accelerometer can also be used as a posture sensor to further simplify the manufacturing process and reduce the cost, so it is not limited.

In addition, when the accelerometer is disposed on the torso, not only information related to snoring can be obtained, but also other physiological information related to sleep breathing, such as breathing and heart rate, can be obtained as described above; in addition, other physiological sensors such as optical sensors can be added, and sleep physiological information such as sleep respiratory events, sleep respiratory physiological information, respiratory behaviors, sleep stages and the like can be acquired from the surface of the trunk or the neck, so that the detection result is more accurate through mutual comparison among various sleep physiological information.

Furthermore, an alarm unit can be added to provide sleep posture training and/or sleep breathing physiological feedback training. For example, the obtained sleep posture related information can be compared with a preset posture range, and when the sleep posture related information conforms to the preset posture range, a warning behavior is determined and a warning is provided so as to execute the sleep posture training; or the acquired sleep breathing physiological information, such as snoring related information, breathing action, heart rate and the like, can be compared with preset conditions to determine warning behaviors when the conditions are met and provide warnings to execute sleep breathing physiological feedback training; alternatively, appropriate sleep posture training and sleep breathing physiological feedback training may be provided during the same sleep period by observing both kinds of sleep physiological information. Thus, there are various implementations possible, without limitation.

The control unit is configured to generate a driving signal, and the warning unit generates at least one warning after receiving the driving signal and provides the warning to the user to achieve the purpose of sleep posture training and/or sleep breathing physiological feedback training, wherein the driving signal is generated according to the determined various warning behaviors. It should be noted that, as is well known to those skilled in the art, the operation of the device/system must have basic circuit configurations such as a control unit, a communication module, a power module, etc., and these are repeated, so that the description of all the following embodiments will be omitted for brevity, and the actual circuit configurations of all the devices in the present application are not limited thereto.

Another implementation possibility is a sleep physiology system comprising a housing and a wearing structure for placing the housing on a user's body, and in obtaining sleep physiology information, the sleep physiology information is obtained by a posture sensor for obtaining sleep posture related information of the user during sleep and a physiology sensor for obtaining blood physiology information during sleep, wherein, in particular, the sleep posture related information is obtained by using a trunk and a neck above the trunk as optimal positions, so that the light sensor obtains blood physiology information from the skin surface of the trunk or neck, such as heart rate, and in particular, as mentioned above, sleep stage related information can be obtained by further analyzing the heart rate, for example, the information about sleep quality can be obtained by analyzing the heart rate distribution, or by calculating the HRV (heart beat variation rate), performing Hilbert-Huang transform (HHT) or other conventional analysis methods, and then by knowing the sleep stage distribution, such as the proportion of deep sleep and light sleep in the whole sleep period. This is very helpful information for the user, especially, the sleep posture training is to change the sleep posture through the warning, so as to achieve the effect of reducing sleep apnea/hypopnea, and observe the sleep stage distribution/sleep quality during the training period, which is helpful to adjust the parameter setting providing the warning, so as to make the training process more comfortable.

In addition, when the posture sensor is implemented as an accelerometer, the accelerometer can acquire the physical activity during the sleep period, and can further analyze the physical activity together with the blood physiological information to acquire more accurate sleep stage related information. Further, the blood physiological information can be used to obtain other sleep physiological information, such as sleep respiration physiological information, sleep respiration events, heart rate variability, and arrhythmia.

In this case, when the alarm unit is provided, the sleep posture related information can be compared with the preset posture range, and the alarm behavior can be determined when the preset posture range is met, and an alarm is provided to perform the sleep posture training, and in addition, since the blood physiological information can be continuously detected during the sleep, the blood physiological information can be used to confirm the improvement effect of the alarm, for example, whether the occurrence of the sleep respiratory event is reduced due to the change of the sleep posture, and various related information other than the blood physiological information can be provided to the user through the information providing interface, for example, the number of times of executing the alarm, the time point, the change of the sleep posture, the proportion of different sleep postures, the occurrence number of the sleep respiratory event, the time point, etc., so that the user can clearly know whether the performed sleep posture training has the effect and why the effect, therefore, the obtained blood physiological information can be used as a basis to adjust the warning behavior, so that the warning can be provided more effectively, and the disturbance to the sleep of the user can be minimized, thereby being quite advantageous.

Of course, in order to understand the difference before and after the sleep posture training, it can also be implemented that the warning unit does not provide warning at first, but only obtains the sleep posture of the user, and matches with the blood physiological information to know the relation between the occurrence of the sleep breathing event and different sleep postures, so that when the sleep posture training is started, the effect of providing warning or not can be further obtained, for example, the proportion change of different sleep postures, whether the occurrence of the sleep breathing event is reduced or not, and the like.

Further, the alert behavior may also be implemented to be determined according to the sleep posture related information and/or the blood physiological information, i.e., the sleep posture training, the sleep respiration physiological feedback training, or both may be performed together during the same sleep period, and thus, there are various possibilities without limitation.

In another embodiment, a sleep physiology system comprises at least a shell and a wearing structure for disposing the shell on the forehead of a user, and in terms of obtaining sleep physiology information, the wearing structure is achieved by a posture sensor and an optical sensor, wherein the posture sensor is used for obtaining sleep posture related information of the user during sleep, and the optical sensor is used for obtaining blood physiology information, such as blood oxygen concentration and heart rate, from the forehead during sleep.

Such a system provides a variety of advantageous implementation options. For example, the alert unit may be optionally implemented to provide an alert according to the sleep posture related information, in which case, the blood physiological sleep respiratory events derived according to the blood physiological information, such as oxygen desaturation events, low oxygen level events, and heart rate change sleep respiratory events, will help the user to know the sleep respiratory conditions during the sleep posture training, such as the distribution of the sleep respiratory events in different sleep postures, so as to provide the posture related information of the blood physiological sleep respiratory events of the user, such as the posture related information of the oxygen desaturation events, and also know the training execution effect, such as the occurrence number of the sleep respiratory events during the training process changes, whether the sleep respiratory events are reduced due to posture change, and the like; in addition, the warning unit can also be selectively implemented to provide warning according to the sleep posture related information and the blood physiological information, so that the sleep posture training and the sleep respiration physiological feedback training can be provided together in the same sleep period, and the improvement effect is more comprehensive; alternatively, it is also possible to determine whether a sleep breathing event occurs and the correlation between the occurrence of the sleep breathing event and the sleep posture based on the acquired sleep physiological information without providing the warning, and then select which training to perform based on the determination result.

Moreover, most importantly, the user can achieve the above functions and selections only by simply setting the device on the forehead, can evaluate the sleep disordered breathing, and can select the functions according to the needs, especially, the blood oxygen concentration change is one of the most widely accepted physiological parameters with the highest correlation for judging the sleep disordered breathing, and the most effective result can be obtained under the simplest configuration.

Furthermore, other physiological sensors may be provided, for example, an acceleration sensor or a microphone may be provided to obtain information related to snoring, so as to provide a basis for warning, and perform sleep posture training and/or sleep breathing physiological feedback training based on snoring, so as to more fully understand the occurrence of sleep breathing disorder, and particularly, the accelerometer may also be used as a posture sensor, thereby further simplifying the manufacturing process and reducing the cost; the brain electricity electrode, the eye electricity electrode and/or the myoelectricity electrode can be arranged to obtain brain electricity signals, eye electricity signals and/or myoelectricity signals, and by analyzing the brain electricity signals, the eye electricity signals and/or the myoelectricity signals, the sleep state/stage, the sleep cycle and the like during sleep can be obtained, so that the distribution situation of the sleep respiratory events in each sleep stage and the relation between the sleep posture and the sleep stage are provided, and further understanding is facilitated.

Here, since the position of the wearing structure is the forehead, the wearing structure can be implemented as a headband and/or an adhesive structure, and particularly, can be implemented as an eye mask, and the eye mask usually covers at least a part of the forehead when worn, so that the optical sensor can obtain blood physiological information by only arranging the shell at a position where the shell can contact the forehead, and the use of the eye mask during sleep is an extremely advantageous choice to help falling asleep; in addition, the arrangement position of the forehead also enables the variety of the warning to be selected more, and the warning can be implemented as tactile warning, auditory warning and/or visual warning without limitation; in addition, it is also advantageous to add a housing, for example, two or more electrically connected housings, to reduce the volume of the respective housing and to further conform to the curvature of the forehead.

Furthermore, when it is necessary to provide information to a user, the information can be provided through setting an information providing interface, or the information can be provided through setting a communication module, for example, a wireless communication module such as bluetooth, BLE, Zigbee, WiFi, RF, etc., or a wired communication module such as a USB interface, UART interface, etc., and transmitted to another wearable device, for example, an intelligent wearable device, or transmitted to an external device, for example, an intelligent mobile phone, a tablet computer, a personal computer, or other device capable of receiving information and having an information providing interface, so as to provide information by using the information providing interface thereon, which is not limited.

In another embodiment, a sleep physiology system comprises a housing and a wearing structure for mounting the housing on a user, wherein the acquisition of sleep physiology information is achieved by a posture sensor for acquiring a sleep posture of the user during sleep, a first physiology sensor for acquiring two kinds of sleep respiration physiology information, and a second physiology sensor for acquiring snoring-related information during sleep to obtain snoring events, wherein the second physiology sensor is configured for acquiring blood physiology information during sleep to obtain blood physiology sleep respiration events and for providing the blood physiology sleep events to the user through an information providing interface.

As described above, sleep disordered breathing is divided into snoring and sleep apnea/hypopnea, and therefore, if both kinds of sleep disordered breathing information can be provided simultaneously, it would be a convenient alternative for the user, in particular, snoring is generally regarded as a precursor to sleep apnea/hypopnea, furthermore, the occurrence of sleep apnea/hypopnea is often accompanied by the occurrence of snoring, for example, but not limited to, one in which the respiratory tract is gradually blocked to make the respiratory sound gradually heavy and snoring occurs, and finally sleep apnea/hypopnea occurs, and another in which, after sleep apnea occurs, snoring occurs when breathing resumes, therefore, these two physiological phenomena can be used in most cases as a basis for determining whether sleep apnea/hypopnea is actually occurring; furthermore, when the physiological information of blood is used as the basis for determining the physiological sleep respiratory event of blood, such as oxygen desaturation, heart rate variation, hypoxia level, etc., the physical action is likely to cause artificial interference (artifact) to the physiological signal, which leads to erroneous determination.

Accordingly, in this implementation possibility, by observing the physiological information of blood and the information related to snoring at the same time, when a preset condition combination is met, such as the time sequence relation, the sequence order, etc., of the two, it is determined whether the physiological sleep breathing event of blood occurs, so as to achieve the purpose of providing more accurate information.

In this case, the acquisition of the sleeping posture is most considered when selecting the setting position, and therefore, the setting position of the housing is preferably the head, the trunk, and the like, and when setting the housing on the trunk, the acquisition of the snoring-related information can be achieved by, for example, an accelerometer, the body cavity resonance caused by snoring, and a microphone, and the detection of sleep apnea can be achieved by, for example, an optical sensor, the blood physiological information including the heart rate; in addition, when the device is arranged on the head, the accelerator and/or the microphone can be used for obtaining information related to snore, the blood physiological information including blood oxygen concentration, heart rate and the like can be obtained by the detection of sleep apnea/hypopnea through the optical sensor, and then blood physiological sleep respiratory events, such as oxygen desaturation events, low oxygen level events and heart rate change sleep respiratory events, can be obtained according to the blood physiological information.

When the wearing structure is arranged on the head, besides the head band and/or the adhesion structure, the wearing structure can be also specifically implemented in the form of an eye mask, especially during sleeping, the use of the eye mask is beneficial to falling asleep, and the forehead is originally suitable for arranging a posture sensor, and the forehead area contacted by the eye mask is just suitable for placing a physiological sensor, such as a photosensor, an electroencephalogram electrode, an electrooculogram electrode and a myoelectricity electrode, so that various physiological information for understanding sleeping physiology can be obtained.

Then, the relative information of the sleeping posture obtained by the posture sensor is compared, and under the condition of meeting the preset sleeping posture range, and the distribution of the snoring events and the physiological sleep breathing events of the blood respectively occurring in case of exceeding the preset sleeping posture range, for example, a posture-related snore index, a number of posture-related snores, a posture-related snore duration, a posture-related sleep apnea index, a number of posture-related blood physiology sleep respiratory events, and a posture-related blood physiology sleep respiratory event duration, etc., the information is very helpful for the user, not only can know that the sleep disordered breathing is snoring and/or sleep apnea, but also can further understand the relationship between the occurrence of various sleep disordered breathing and the sleep posture, and has strong function and convenient use.

Furthermore, when the head is equipped with an electroencephalogram electrode, an electrooculogram electrode, and/or an electromyography electrode, the electroencephalogram signal, the electrooculogram signal, and/or the electromyography signal can be obtained, and by analyzing the electroencephalogram signal, the electrooculogram signal, and/or the electromyography signal, the sleep state/stage, the sleep cycle, the sleep quality, and the like during sleep can be obtained, and further, various information such as the distribution of sleep respiratory events in each sleep stage, the relationship between the sleep posture and the sleep stage, and the relationship between the sleep quality and the sleep disordered breathing can be provided, which is more helpful for obtaining further understanding.

Furthermore, an alarm unit can be added to provide sleep posture training and/or sleep breathing physiological feedback training. For example, the obtained sleep posture related information can be compared with a preset posture range, and when the sleep posture related information conforms to the preset posture range, a warning behavior is determined and a warning is provided so as to execute the sleep posture training; or the obtained snoring related information and/or the blood physiological information can be compared with a preset condition so as to determine an alarm behavior when the preset condition is met, and an alarm is provided so as to execute sleep breathing physiological feedback training; alternatively, appropriate sleep posture training and sleep breathing physiological feedback training may be provided during the same sleep period by observing both kinds of sleep physiological information. Thus, there are various implementations possible, without limitation. Moreover, the warning unit can be disposed at different positions according to requirements, for example, the warning unit can be disposed in the housing, on another wearable device, or on an external device, so that various options are available.

In another implementation, a sleep physiology system includes a housing, at least one wearing structure, a control unit including at least a microcontroller/microprocessor, at least one respiratory airflow sensor electrically connected to the control unit, a physiology sensor electrically connected to the control unit, a communication module electrically connected to the control unit, and a power module, wherein, through the at least one wearing structure, as shown in fig. 8, the housing 801 and the at least one respiratory airflow sensor 802 are disposed between the mouth and nose of a user, i.e., in a person, to obtain sleep respiratory airflow changes during the sleep of the user, and further, the physiology sensor is used to obtain another sleep physiology information, wherein, the at least one respiratory airflow sensor can be implemented as a thermistor, a thermocouple, or an airflow tube without limitation, the respiratory airflow tube detects the flow change of the respiratory airflow, the temperature change caused by the respiratory airflow is detected by the thermistor and the thermocouple, and two detection points (near two nostrils) or three detection points (near two nostrils and near the mouth part) can be selectively arranged.

In this configuration, in particular, as is well known, measuring the respiratory airflow is the most direct way of knowing the respiratory situation, and may further derive sleep apnea events and/or sleep hypopnea events, and, therefore, in the case where the size of the housing is small enough, for example, the size is less than 20x20x20mm, then, as shown in fig. 8, the breathing air flow sensor can be arranged between the mouth and the nose only through a proper wearing structure, and the breathing air flow sensor is also arranged between the mouth and the nose, wherein, the wearing structure can have many options, for example, the shell can be fixed between the mouth and the nose by using a sticking way, and the shell can be stuck to the area between the mouth and the nose or two sides of the mouth selectively, or, the casing and the respiratory airflow sensor can also be arranged by utilizing a fixed structure clamped on the nasal septum and/or the two side nasal wings, or, the fixing is carried out by clamping and pasting, so that the fixing method is not limited and can be any fixing method; preferably, in addition to the commonly used plastic shell material, the shell may also be made of a soft or elastic material to provide optimal comfort.

The physiological sensor can be implemented as an accelerometer to obtain more sleep physiological information during sleep, such as sleep posture and snoring related information, as an optical sensor to obtain blood oxygen concentration and heart rate, or as a microphone to obtain snoring related information, and the physiological sensor can be combined with the respiratory airflow change to further understand sleep disordered breathing.

The at least one wear structure may be implemented as two wear structures, each removably associated with the housing to mount the housing to other body parts, such as the forehead, ears, torso, fingers, wrists, arms, etc., at which time the physiological sensor may be configured to acquire various physiological information such as blood oxygen concentration changes, heart rate, snoring related information, sleeping posture, sleeping physical activity, daily physical activity, etc., as another use option, and in particular, since the sampling location of the respiratory airflow sensor is defined between the mouth and the nose, when the housing is separated from the wear structure mounted thereto, it may be implemented to be separated from the respiratory airflow sensor as well, thus allowing for a more convenient structure when combined with another wear structure and mounted to other body parts.

In addition, for reasons of hygiene and/or availability for multiple persons, it is likewise advantageous if the breathing gas flow sensor and the housing can be embodied in a removable form, i.e. in the form of a replaceable breathing gas flow sensor, even without further detection in the replacement position.

The sleep physiological system also can comprise a wearing device, and the wearing device is provided with another physiological sensor, e.g., light sensors, accelerometers, microphones, etc., are positioned at locations such as the wrist, fingers, torso, head, etc., to obtain additional sleep physiological information such as blood oxygen concentration variation, heart rate, respiratory movement, snoring related information, sleep posture, sleep physical activity, and so on, by comparing various sleep physiological information, the judgment can be performed more frequently, for example, under the condition that the respiratory airflow sensor can obtain the actual respiratory airflow change, if the respiratory action is obtained by matching with an accelerometer arranged on the trunk, the sleep apnea event and/or the sleep hypopnea event which occur can be judged to belong to the obstructive sleep apnea with fluctuant chest and abdomen or the central sleep apnea with no fluctuant chest and abdomen.

The sleep breathing system can also be additionally provided with a warning unit to provide warning according to the breathing airflow change and/or the sleep physiological information, wherein if the sleep physiological information comprises a sleep posture, the sleep breathing system can be used for executing sleep posture training, and/or the sleep breathing system can be used for executing sleep breathing physiological feedback training including the breathing airflow change and/or other sleep physiological information, and the warning unit can be arranged in the shell, and can also utilize an external device, such as a bracelet, a watch, a mobile phone and the like which are communicated with a communication module arranged in the shell, so that the limitation is avoided.

It can be known up to this point that the utility model discloses a sleep physiology system, how to set up it has its importance on one's body in the user, especially, the tactile warning that warning unit provided, for example, vibration warning, need have stable and inseparable contact between the skin of casing and setting position, just can transmit the vibration for the user effectively, in addition, there are the physiological information acquisition of many physiological sensors also need to have good contact with between the skin, for example, the best sampling mode of light sensor is exerting pressure on skin a little, posture sensor, accelerometer etc. can effectively detect under the state of hugging skin most survey sleep posture, the body cavity vibration that snore caused, the chest and abdomen undulation that the breathing action caused, the health action during sleep etc..

One option is to attach the housing to the skin, for example, by means of an adhesive structure, which can be provided as long as the housing is of a suitable size; in addition, the elastic clothes can be used as a medium for arranging the shell so that the shell is closely attached to the body surface.

The embodiment provides a fixing structure to generate a fixing force to make the shell arranged on a piece of clothes, and at least one part of the clothes can provide an elastic force to apply force to the skin surface when a user wears the clothes, so that a compact layered structure comprising the shell, the clothes and the skin surface is formed, and the shell can be tightly attached to the body surface through the compact layered structure and the elastic force, and the effect can be better no matter the tactile warning is provided or the physiological sensor is arranged.

The housing may be disposed inside the clothing and between the clothing and the skin surface, or may be disposed outside the clothing and tightly attached to the lifting table through the clothing, or if the physiological sensor needs to obtain physiological information from the body surface, such as an optical sensor, the housing should be disposed with the surface having the physiological sensor facing the skin surface of the trunk.

The fixing manner of the fixing structure and the clothes can be changed according to actual requirements without limitation, for example, the fixing structure can be adhered to the clothes, for example, the shell is adhered to the clothes by the adhering structure; the clamping structure may be implemented, for example, a mechanical clamping structure, a magnetic clamping structure, etc., and various options are available.

The preferred embodiment of the clamping structure is to have a containing groove for receiving the shell to achieve the combination between the shell and the clamping structure, and then the clamping structure is clamped on the clothes to achieve the setting of the shell at the same time, which is very convenient, wherein the containing groove can be set inside or outside the clothes according to different requirements, and in addition, if the physiological sensor is set on the surface of the shell, the shell needs to pay attention to the exposure of the physiological sensor when being placed in the containing groove, without limitation.

When the magnetic clamping structure is adopted, a preferred embodiment is that a magnetic material is disposed at the end of the casing to achieve the effect of magnetic attraction and fixation with another magnetic material at the other end across the clothes, wherein the magnetic material can be disposed in the casing, for example, a battery made of metal and capable of achieving magnetic attraction is additionally disposed in the casing as the magnetic material, or disposed outside the casing, for example, disposed in the containing groove together with the casing or embedded in the containing groove, which is a practical option; in addition, an elastic connecting piece can be further arranged between the containing groove and the other end with the other magnetic material, and the clamping idea is formed by utilizing the characteristic of flexibility.

It should be noted that the elasticity of the clothing may be from the material used to make the clothing, such as elastic cloth, or from the elastic object added to the clothing, such as sewn elastic band, and the clothing may be clothing, such as tights, underwear, trousers, etc., or other clothing arranged on the trunk, such as a circumferential belt, e.g., RIP sensor arranged on the trunk, and is not limited thereto.

Therefore, the sleep physiology system of the present invention has different embodiments according to different use requirements and different hardware configurations, for example, the setting position can be selectively changed according to the requirements, so that, as shown in fig. 9, the requirements for setting different body parts can be simply met by matching different wearing structures, for example, removable form between the shell and the wearing structure, which is quite advantageous.

In another aspect of the present invention, the alarm unit is utilized to generate an alarm to the body for performing the sleep posture training and/or achieving the sleep breathing physiological feedback, and the oral closing auxiliary member is utilized to achieve the improved effect for the symptom of the obstructive sleep apnea. The mouth closing auxiliary part is arranged around or near the respiratory tract during sleeping so as to improve the problem of respiratory tract collapse.

The chin strap 901, as shown in fig. 10A, is a known mouth closing auxiliary assembly for improving the symptoms of snoring and obstructive sleep apnea, which surrounds the head with a strap and applies force to the chin to lift the chin bone of the user, and pulls the muscles of the throat through the mouth closing action, so as to make the upper respiratory tract more easily maintain unobstructed, so that even during the sleep period with relaxed muscles, the effects of maintaining the mouth closed and the respiratory tract unobstructed can be achieved, and the symptoms of snoring and obstructive sleep apnea can be improved.

Another known oral closure aid for improving airway constriction and/or collapse during sleep is an oral positioning abutment 902, as shown in fig. 10B, which reduces the opening of the mouth during sleep by positioning the upper and lower lips in a closed position, which has a similar effect to the chin strap described above, and which achieves the effect of pulling the muscles of the throat by maintaining the mouth closed, so as to make the upper airway more easily open, and in this way, also avoids the situation of breathing in the mouth, and is therefore a simple and effective alternative.

Since the mouth closing assisting element is provided for improving the snoring and the obstructive sleep apnea/hypopnea, the effect of opening the respiratory tract is different according to different persons, for example, the structure of the throat of each person is different, and the sleeping posture is also different, so that if the physiological information, such as the information related to the snoring, the blood oxygen concentration, the heart rate, the respiratory airflow variation, the respiratory action and the like, can be obtained simultaneously during the use period, so as to know whether the symptoms of the respiratory tract stenosis are improved, for example, whether the occurrence frequency of the oxygen desaturation respiratory event, the low oxygen level respiratory event, the heart rate variation respiratory event, the snoring event, the sleep apnea event and/or the sleep hypopnea event is reduced, the mouth closing assisting element is a more beneficial combination way for the user.

Thus, physiological sensors, such as light sensors, accelerometers, airflow sensors, piezoelectric motion sensors, impedance sensing electrodes, RIP sensors, piezoelectric vibration sensors, and/or microphones, may be used in conjunction with the sensor. For example, the user may first use the optical sensor to detect during sleep, and if a blood physiological sleep respiratory event, such as an oxygen desaturation respiratory event, a low oxygen level respiratory event, a heart rate change respiratory event, or an accelerometer, a microphone, and/or a piezoelectric vibration sensor is found to obtain information related to snoring to know whether a snoring respiratory event occurs or other physiological sensors to obtain other sleep respiratory events, then the user may further use the mouth closing aid during sleep to maintain the clear respiratory tract, and use the physiological sensor to perform physiological monitoring while using the mouth closing aid, so that the user can clearly know the improvement effect brought by using the mouth closing aid, such as whether the occurrence of the sleep respiratory event is reduced, which is very convenient; besides, it can be known how to achieve the effect of the mouth closing device, and it can also be used as the basis for adjusting the setting of the mouth closing auxiliary device, such as the tightness and setting angle of the chin strap, or the viscosity and coverage of the mouth positioning adhesive device, which is helpful to further improve the effect of the mouth closing device.

In a preferred embodiment, the oral closure accessory can be matched with a sleep physiological device, which comprises a control unit at least comprising a microcontroller/microprocessor, a physiological sensor electrically connected to the control unit and used for obtaining sleep respiration physiological information of a user during a sleep period, a communication module, a power module and a wearing structure, and is arranged on the user body through the wearing structure, wherein the control unit can analyze the sleep respiration physiological information to obtain a sleep respiration event and provides the sleep respiration event for the user by utilizing an information providing interface, so that the user can know the improvement effect obtained by using the oral closure accessory, and the oral closure accessory is quite convenient. Moreover, since there are many options for the arrangement position of the physiological sensors, such as the physiological sensors can be arranged between fingers, wrists, torso, forehead, ears, mouth and nose, the present invention can be easily achieved by matching various wearing structures, such as finger wearing structure, wrist wearing structure, head wearing structure, belt body, patch, etc., or directly arranged on the auxiliary member for closing the mouth, which is very advantageous.

Furthermore, a posture sensor can be further matched to obtain the sleep posture related information, in this case, through the mutual comparison between the obtained sleep breathing physiological information and the sleep posture related information, whether the sleep breathing disorder is posture sleep breathing disorder can be known, and the method is more helpful for knowing the type of the sleep breathing disorder.

Furthermore, the alarm unit can be matched to provide alarm for the user when a sleep respiratory event occurs and carry out sleep respiratory physiological feedback training, so that the upper mouth closing auxiliary piece can help to maintain the smooth respiratory tract, and the two effects are combined to have more advantages; still further, when having both a physiological sensor and a posture sensor, the alert unit may also be implemented to perform sleep posture training and/or sleep breathing physiological feedback training during sleep. Thus, there are various possibilities, without limitation.

On the other hand, the mouth closing aid can also perform sleep posture training together with the posture sensor and the warning unit. For example, in a preferred embodiment, a sleep physiology apparatus may be incorporated that includes a control unit including at least a microcontroller/microprocessor, a posture sensor electrically connected to the control unit, used for obtaining the sleep posture related information of a user during a sleep period, an alarm unit electrically connected with the control unit, for generating at least one alert to the user during the sleep period, a communication module, a power module, and a wearing structure, which is arranged on the user body through the wearing structure to carry out sleep posture training, under the condition, the upper respiratory tract becomes more unblocked with the help of the mouth closing auxiliary part, the effect of the sleep posture training is more obvious, moreover, through the information providing interface, the user can know the influence of the mouth closing auxiliary piece on the sleeping posture and the warning behavior; in another preferred embodiment, the physiological sensor, such as an optical sensor, a respiratory airflow sensor, an accelerometer, a piezoelectric motion sensor, an impedance detection electrode, an RIP sensor, a piezoelectric vibration sensor, a microphone, etc., may be used to obtain sleep breathing physiological information during sleep, and to obtain sleep breathing events, which are provided to the user through the information providing interface, so that the effect of using the mouth closing aid on improving sleep breathing disorders can be obtained. Thus, there are various possible combinations, without limitation.

The sleep posture training and/or the sleep breathing physiological feedback training are performed by comparing the sleep posture related information with a preset posture range, determining a warning behavior when the sleep posture related information meets the preset posture range, and providing a warning to perform the sleep posture training. The alarm is provided by the control unit being configured to generate a driving signal, and the alarm unit generating at least one alarm after receiving the driving signal and providing the at least one alarm to the user for the purpose of sleep posture training and/or sleep breathing physiological feedback training, wherein the driving signal is generated according to the determined various alarm behaviors.

The physiological sensor, the posture sensor, and/or the warning unit may be implemented, for example, by any suitable sleep physiological apparatus, sleep breathing physiological apparatus, or sleep warning apparatus in the above embodiments, or may be implemented in another wearable apparatus or an external apparatus without limitation, and further, if the installation position of the mouth closing auxiliary is the position where the physiological sensor, the posture sensor, and/or the warning unit can be installed, the physiological sensor, the posture sensor, and/or the warning unit can also be used as a medium for installation, for example, the respiratory airflow sensor can be installed between the mouth and the nose, and the posture sensor, the accelerometer, and the microphone can be installed at the top of the head or at the chin, so as to make the installation easier.

In particular, if a head-mounted structure is used, in particular in the form of a band, it can further be provided that the head-mounted structure and the chin band are coupled to one another in order to further increase the stability of the arrangement.

The common chin strap is in the form shown in fig. 10A, and due to the fact that the common chin strap covers the hair, slipping is prone to occur, the stability of the arrangement is reduced, falling off during sleeping is not noticeable, and finally the using effect is poor. As shown in fig. 10C, when the head-wearing structure 903 is combined, the forehead is set, and the setting direction is just crossed with the chin strap 901, so that the combination of the forehead and the chin strap can further provide a transverse limiting force for the chin strap, that is, the phenomenon that the top of the head of the chin strap slides easily can be effectively reduced through the mutual interference between the transverse strap and the longitudinal strap, and the whole arrangement is more stable.

Further, there may be other variations, for example, as shown in fig. 10D, a belt may be additionally provided on the top of the head; alternatively, as shown in fig. 10E, the chin strap may be implemented to longitudinally surround only the lower half of the head by laterally surrounding the head with the headband to provide a mutual interference force with the head, and in this case, further variations may be implemented, for example, the headband portion may be changed to a hat or the like having or not having a crown covering portion. Therefore, there are various possibilities without limitation.

Furthermore, the combination of the chin strap and the head-wearing structure may also be varied according to the actual implementation, for example, the chin strap and the head-wearing structure may be combined with each other by providing a hook-and-loop fastener, a snap-fit structure, a threading structure, etc., and thus, the chin strap and the head-wearing structure may be removable, or may be directly sewn, without limitation, as long as the combination between the chin strap and the head-wearing structure can be achieved.

It should be noted that, in the above embodiments, the analysis of the physiological information, the determination of whether the sleep breathing event occurs, the determination of whether the alarm is provided, and/or the determination of the alarm behavior, etc. are achieved by various software programs, and the various software programs, without limitation, can be implemented in any wearable device and/or in an external device to perform operations so as to achieve the most convenient operation mode for the user, and thus may be changed according to actual requirements without limitation.

In the above embodiments, the wearing structure for installing the posture sensor, the physiological sensor, the housing, the device, and/or the system on the body of the user may be changed according to the installation position of the actual requirement, for example, the material may be changed, and the wearing structure of the same type may be installed on different body parts as long as it is suitable, for example, the wearing structure of the band type may be installed on any part of the body that can be surrounded, for example, a head band, a neck band, a chest band, a belly band, an arm band, a wrist band, a finger band, a leg band, etc., and may be implemented by various materials, for example, fabric, silica gel, rubber, etc., and the adhesion structure, for example, a patch, has almost no position limitation, as long as the position where adhesion can be performed, and may also be adhered to the clothes on the body of the user; furthermore, the specific body position may have a dedicated wearing structure, for example, the head may be provided with an eye mask, which is particularly suitable for use during sleep, the arms may be provided with an arm wearing structure, the wrist may be provided with a wrist wearing structure, the fingers may be provided with a finger wearing structure, etc., so that the actual use form will not be limited by the description of the above embodiments, and various possibilities are possible.

Moreover, when various wearing structures are used to carry the housing/device, the combination of the two may be implemented in various ways, for example, by adhesion, by clamping, such as mechanical clamping, magnetic clamping, or by sleeving, such as by having a structure on the wearing structure that can sleeve the housing/device, or by plugging, such as by having a structure on the wearing structure that can plug the housing/device, so long as the combination of the housing/device and the wearing structure can be selected appropriately, and the combination of the various ways can be further implemented in a non-removable or removable manner. Therefore, the present invention can be changed according to the actual requirements, and is not limited to the description of the above embodiments.

In the above embodiments, any information, whether obtained directly by the physiological sensor, calculated by the analysis program, or other information related to the operation process, is provided to the user through the information providing interface, and the information providing interface may be implemented on any one or more devices in the system, without limitation.

In addition, the contents of various acquired sleep physiological information in the above embodiments can be applied to any kind of physiological sensor, any setting position, and any calculation method executed according to the acquired physiological information mentioned above, which are only based on the principle that description is not repeated and are not listed one by one, but the scope of the claims of the present invention is not limited thereby.

Moreover, the above-mentioned circuit configurations of the embodiments should also be applied to the devices disclosed in the above-mentioned embodiments, and may be changed according to the physiological information to be obtained and the installation location of the embodiments, which are not listed based on the principle of not repeated descriptions, but the scope of the claims of the present invention is not limited thereby.

Furthermore, the above-described embodiments are not limited to be implemented individually, but may be implemented by combining or combining parts or all of two or more embodiments, and are not limited to the scope of the present invention.

Claims

1. A sleep physiology system comprising:

a housing;

a control unit, accommodated in the housing, at least comprising a microcontroller/microprocessor;

at least one respiratory airflow sensor electrically connected to the control unit;

a physiological sensor electrically connected to the control unit;

a communication module electrically connected to the control unit;

a power module; and

at least one wearing structure for carrying the shell and arranging the shell and the at least one respiratory airflow sensor between the mouth and the nose of a user during a sleep period,

wherein,

the at least one airflow sensor is configured to detect changes in the user's sleep airflow during the sleep of the user; and

the physiological sensor is configured to acquire a sleep physiological information and/or a sleep respiratory event during the sleep of the user.

2. The system of claim 1, wherein the at least one respiratory airflow sensor is implemented as at least one of: thermistors, thermocouples, and gas flow tubes.

3. The system of claim 1, wherein the physiological sensor is implemented as at least one of the following, comprising: a light sensor, an accelerometer, and a microphone.

4. The system of claim 3, wherein the sleep physiological information is embodied as at least one of: blood oxygen concentration changes, heart rate, snoring related information, and sleep posture related information.

5. The system of claim 1, wherein the system further comprises another wearable device having another physiological sensor for acquiring at least one of the following physiological information of the user during the sleep period, comprising: blood oxygen concentration changes, heart rate, snoring related information, respiratory motion, and sleep posture related information.

6. The system of claim 1, wherein the at least one wear structure is implemented as two wear structures and the housing is implemented to be removably coupled with the two wear structures, respectively, to be disposed between the mouth and nose and to be disposed on another body part, respectively, and when disposed on the other body part, the physiological sensor is configured to acquire a physiological information of the user, including at least one of: blood oxygen concentration changes, heart rate, snoring related information, sleep posture related information, sleep physical activity, and daily physical activity.

7. The system of claim 1, wherein the at least one wear structure is implemented as one of: an adhering structure adhered between the mouth and the nose, a fixing structure combined with at least one part of the nose, and at least one mouth closing auxiliary member.

8. The system of claim 1, further comprising an alert unit for generating at least one alert and implemented as one of: the control unit is further configured to generate a driving signal, and the warning unit generates the at least one warning after receiving the driving signal and provides the at least one warning to the user, wherein the driving signal is generated according to a warning behavior determined at least according to the sleep respiratory airflow change and/or the sleep physiological information.

9. The system of claim 1, further comprising an information providing interface implemented as at least one of: the shell is arranged on the shell, is electrically connected to the control unit, is arranged on another wearing device and is arranged on an external device.

10. The system of claim 9, wherein the control unit communicates with the another wearable device and/or the external device via the communication module in a wired or wireless manner.

11. A sleep physiology system comprising:

a sleep physiological apparatus comprising:

a control unit at least comprising a microcontroller/microprocessor;

a posture sensor electrically connected to the control unit for obtaining sleep posture related information of a user during a sleep period;

the warning unit is electrically connected to the control unit and used for generating at least one warning for the user during the sleeping period;

a communication module electrically connected to the control unit;

a power module; and

a wearing structure for arranging the sleeping physiological device on the user; and

at least one mouth closure aid for positioning adjacent the mouth of the user during the sleep period,

wherein,

the control unit is configured to generate a driving signal, and the warning unit generates the at least one warning after receiving the driving signal and provides the at least one warning to the user, wherein the driving signal is generated according to a warning behavior determined when the sleep posture related information conforms to a preset posture range after comparing the sleep posture related information with the preset posture range; and

the at least one oral closure aid being configured to affect at least a portion of the upper airway of the user, and

wherein,

the system also includes an information providing interface for providing information related to the sleep posture and/or information related to the alert behavior to the user.

12. The system of claim 11, wherein the at least one oral closure aid is embodied as at least one of the following, comprising: a chin strap and an oral positioning fitting piece.

13. The system of claim 11, further comprising a physiological sensor for acquiring physiological information of sleep breathing of the user during the sleep period, comprising at least one of: optical sensors, accelerometers, respiratory airflow sensors, piezoelectric motion sensors, impedance sensing electrodes, respiratory plethysmography sensors, piezoelectric vibration sensors, and microphones.

14. The system of claim 13, wherein the sleep breathing physiological information is further based on whether the user has sleep breathing events during the sleep period, and the sleep breathing events include at least one of: oxygen desaturation events, low oxygen level events, heart rate variability sleep breathing events, snoring events, sleep apnea events, and sleep hypopnea events.

15. The system of claim 14, wherein the information providing interface further provides at least one of the following information to the user, including: the sleep respiration physiological information and the information related to the sleep respiration event.

16. The system of claim 13, wherein the physiological sensor is implemented as at least one of the following, comprising: the sleep physiological device is arranged in the sleep physiological device, arranged on the at least one oral part closing auxiliary piece, arranged in another wearing device and arranged in an external device.

17. A sleep physiology apparatus included in a sleep physiology system, the sleep physiology system including the sleep physiology apparatus and at least one port closure aid for positioning adjacent to a user's mouth during a sleep session, the sleep physiology apparatus comprising:

a control unit at least comprising a microcontroller/microprocessor;

a posture sensor electrically connected to the control unit for obtaining the sleep posture related information of the user during the sleep period;

a communication module electrically connected to the control unit;

a power module; and

a wearing structure for arranging the sleeping physiological device on the user body,

wherein,

18. A sleep physiology system comprising:

a sleep physiological apparatus comprising:

a control unit at least comprising a microcontroller/microprocessor;

a physiological sensor electrically connected to the control unit for acquiring sleep respiration physiological information of a user during a sleep period;

a communication module electrically connected to the control unit;

a power module; and

wherein,

the at least one oral closure aid being configured to affect at least a portion of the upper respiratory tract of the user to achieve an improvement in sleep disordered breathing of the user; and

the sleep respiration physiological information is used to derive at least one sleep respiration event, an

Wherein,

the system also includes an information providing interface for providing the at least one sleep breathing event to the user to inform the user of the improved effect.

19. The system of claim 18, wherein the physiological sensor is implemented as at least one of the following, comprising: optical sensors, accelerometers, respiratory airflow sensors, piezoelectric motion sensors, impedance sensing electrodes, RIP sensors, piezoelectric vibration sensors, and microphones.

20. The system of claim 18, wherein the sleep respiratory event comprises at least one of: oxygen desaturation events, low oxygen level events, heart rate variability sleep breathing events, snoring events, sleep apnea events, and sleep hypopnea events.

21. The system of claim 18, wherein the wear structure is implemented as at least one of the following, comprising: a structure is worn to the finger, a structure is worn to the wrist, a structure is worn to the ear, a structure is worn to the head, the area body, and the paster.

22. The system of claim 18, wherein the at least one oral closure aid is embodied as at least one of the following, comprising: a chin strap and an oral positioning fitting piece.

23. The system of claim 18, wherein the wear structure is implemented in combination with the at least one port closure aid.

24. The system of claim 18, wherein the at least one oral closure adjunct is embodied as the wear structure.

25. The system of claim 18, further comprising a posture sensor for obtaining information related to the user's sleep posture during the sleep session and providing the information to the user through the information providing interface, and wherein the posture sensor is implemented as at least one of: is arranged in the sleep physiological device, is electrically connected to the control unit and is arranged in another wearing device.

26. The system of claim 18, further comprising an alert unit for generating at least one alert to be provided to the user, and wherein the alert unit is implemented as at least one of: is arranged in the sleep physiological device, is electrically connected to the control unit and is arranged in another wearing device.

27. A sleep physiology apparatus included in a sleep physiology system including the sleep physiology apparatus, at least one port closure aid for positioning adjacent to a user's mouth during a sleep session, and an information providing interface, the sleep physiology apparatus comprising:

a control unit at least comprising a microcontroller/microprocessor;

a physiological sensor electrically connected to the control unit for obtaining the sleep breathing physiological information of the user during the sleep period;

a communication module electrically connected to the control unit;

a power module; and

wherein,

Wherein,

the information providing interface provides the at least one sleep breathing event to the user so that the user can know the improved effect.