CN212521748U

CN212521748U - Sleep physiological system

Info

Publication number: CN212521748U
Application number: CN202020742211.3U
Authority: CN
Inventors: 周常安
Original assignee: Individual
Current assignee: Individual
Priority date: 2019-05-14
Filing date: 2020-05-08
Publication date: 2021-02-12
Anticipated expiration: 2030-05-08
Also published as: CN212521755U; CN111938574A; CN111938576B; CN111938577A; CN213551768U; CN111938612A; CN111938572A; CN212521754U; CN111938573A; CN213525123U; CN212521753U; CN111938575A; CN111938576A

Abstract

The utility model provides a sleep physiology system, in a preferred embodiment, the system includes a casing, the structure is dressed to an adhesion formula, be used for setting up this casing in a user's truck, a posture sensor, be used for acquireing the sleep posture relevant information of this user during sleep, a plurality of electrodes, be used for acquireing the electrocardiosignal of this user during sleep and the impedance change of truck position, and this impedance change is used for acquireing this user breathing physiology information in at least one sleep during sleep, and breathe physiology information through comparing this sleep posture relevant information and this at least one sleep, can produce sleep breathing incident posture relevant information.

Description

Sleep physiological system

Technical Field

The present invention relates to a sleep physiological system, and more particularly, to a sleep physiological system capable of evaluating 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; a posture sensor electrically connected to the control unit; a plurality of electrodes electrically connected to the control unit; a communication module electrically connected to the control unit; a power module; and an adhesive wearing structure for disposing the shell on a trunk of a user, wherein the posture sensor is configured to obtain sleep posture related information of the user during sleep; and the plurality of electrodes are configured to obtain a cardiac signal of the user during sleep and obtain an impedance change of the torso portion of the user during sleep, wherein the impedance change is further used as a basis to obtain at least one sleep respiration physiological information of the user during sleep, and the sleep respiration physiological information comprises at least one of the following information: respiratory motion, respiratory frequency, and respiratory amplitude, and wherein the system is configured to determine a sleep respiratory event of the user during the sleep based on the at least one sleep respiratory physiological information; and the system is further configured to determine a distribution of the sleep breathing events when the sleep posture related information conforms to a predetermined sleep posture range and when the sleep posture related information exceeds the predetermined sleep posture range, and to generate a sleep breathing event posture related information accordingly, and wherein the system further comprises an information providing interface for providing the sleep breathing event posture related information to the user.

Another object of the present invention is to provide a physiological system for sleep, including: a housing; a control unit, accommodated in the housing, at least comprising a microcontroller/microprocessor; at least one physiological sensor electrically connected to the control unit; an auditory alarm unit electrically connected to the control unit for generating at least one auditory alarm; a communication module electrically connected to the control unit; a power module; and an ear-worn structure for positioning the housing over an ear of a user, wherein the at least one physiological sensor is configured to obtain at least one sleep physiological information of the user during sleep, and the at least one sleep physiological information includes at least one of: sleep posture related information, and sleep breathing physiological information; and the control unit is configured to generate a driving signal, and the warning unit generates the at least one audible warning after receiving the driving signal and provides the at least one audible warning to the user, wherein the driving signal is further implemented to be generated according to an audible warning behavior determined when the at least one sleep physiological information is matched with a preset posture range and/or a preset condition after being compared with the preset posture range and/or the preset condition.

Drawings

The accompanying drawings are included to provide a better understanding of the present invention and are not intended to constitute an undue limitation on the invention. Wherein:

FIG. 1 shows a schematic circuit diagram of a physiological system for sleep 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;

figure 6 shows a PPG signal and its time domain features;

FIG. 7 is a flow chart illustrating the performance of sleep posture training and/or sleep breathing physiological feedback training in accordance with a preferred embodiment of the present invention;

FIGS. 8A-8C illustrate an adhesive donning structure and possible electrode implementations; and

fig. 9A-9C show implementation possibilities of ear-worn structures.

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

800 shell 801 patch type electrode

802 electrode 803 bonding

804 dry electrode 900 earplug type wearing structure

901 extension rod 902 ear-hanging piece

Detailed Description

Exemplary embodiments of the invention are described below with reference to the accompanying drawings, in which various details of embodiments of the invention are included to assist understanding, and which are to be considered exemplary only. Accordingly, those of ordinary skill in the art will recognize that various changes and modifications of the embodiments described herein can be made without departing from the scope and spirit of the invention. Also, descriptions of well-known functions and constructions are omitted in the following description for clarity and conciseness.

Fig. 1 illustrates a circuit diagram of a system according to the present application, in which 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 and is preloaded with programs to handle communication between hardware components, the control unit enables signaling 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 time stamps or time differences or to control operations.

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

The system may comprise a light sensor, which in this 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 principle of PPG (photoplethysmography), in which light is emitted into body tissue through the light emitting source, and the light detector receives light penetrating blood in 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), which reflects the pulse wave generated by the contraction of the myocardium propagating 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, and the meier Waves (Mayer Waves); in addition, physiological information such as related 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 infrared light, red light, green light, blue light, or white light composed of multiple wavelengths, and at least one light detector to obtain pulse rate/heart rate and other blood physiological information, such as respiration physiological information; 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 component 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 physiological information of respiration obtained by the optical sensor is collectively called respiration behavior.

Alternatively, the light sensor may also comprise at least two light sources, such as a plurality of LEDs, preferably green, infrared, and/or red light, and at least one light detector to obtain the blood oxygen concentration (SPO2), the pulse rate/heart rate, and other physiological information of the blood, such as physiological information of respiration, wherein, when measuring the blood oxygen concentration, two different wavelengths of light are required to be emitted into 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 transmitted and reflected light, the comparison result thereof can determine the blood oxygen concentration, therefore, the measurement of the blood oxygen concentration usually has more restrictions on the position where the light sensor is located, and the position where the light can actually enter the artery, such as the finger, the inner face of the palm, the toe, the sole, etc., especially, when measuring the blood oxygen concentration of the infant, the toe/sole is often used, and the two different wavelengths may be, for example, red light and infrared light, or two wavelengths of green light, 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 wavelengths of light sources can be used according to different purposes, for example, when only the heart rate is to be obtained, as mentioned above, blue light or white light composed of multiple wavelength light sources is also suitable to be selected, and therefore, for more precise description, the "wavelength combination" is used instead of the "wavelength" in the following description to cover the possibility of using multiple wavelength light sources.

In addition, specifically, the light sources with three wavelengths may be provided, for example, in one embodiment, the first light source is implemented as an infrared light source to generate light with a first wavelength combination, the second light source is implemented as a red light source to generate light with a second wavelength combination, and the third light source is implemented as a green light source, a blue light source, or a white light source to generate light with a third wavelength combination, wherein the infrared light source and the red light source are used for obtaining blood oxygen concentration, and the green light source, the blue light source, or the white light source is used for obtaining heart rate; alternatively, in another embodiment, the light of the first wavelength combination is implemented as infrared light or red light, and the light of the second wavelength combination and the light of the third wavelength combination are implemented as green light, blue light, and/or white light, etc., wherein two of the wavelength combinations can be used to obtain the blood oxygen concentration, and the other wavelength combination can be used to obtain the heart rate; alternatively, in another embodiment, the light of the first wavelength combination, the light of the second wavelength combination, and the light of the third wavelength combination are all implemented as green light, wherein the green light of the two wavelength combinations can be used to obtain the blood oxygen concentration, and the green light of the other wavelength combination can be used to obtain the heart rate, and since, as shown above, different parts of the body can obtain different types of blood physiological information, the light source capable of generating multiple wavelengths is provided to achieve the purpose of obtaining various required blood physiological information by moving the same device to different parts of the body, for example, when the blood oxygen concentration is required to be obtained, the device is moved to a position where the light can be injected into an artery, and when the heart rate or other blood physiological information is required to be obtained, only the position of a blood vessel or a micro blood vessel is required. Therefore, there is no limitation.

It should be noted that, when there are three light-emitting sources, the number and the arrangement position of the light detectors can be varied according to the requirement. For example, two photodetectors may be implemented, wherein one photodetector with a single infrared light source and a single red light source is used to obtain blood oxygen concentration, and the other photodetector with a green light source implemented as two together obtains heart rate; alternatively, a single light detector and one infrared light source, one red light source and one green light source can be used to obtain the blood oxygen concentration and the heart rate; alternatively, a single photodetector may also acquire heart rate with three green light sources in addition to acquiring blood oxygen concentration with a single red light source and a single infrared light source, and thus, is not limited.

In addition, in the selection of the photo detector, when detecting the blood oxygen concentration, since the environment contains other light sources, it is preferable that the photo detector receiving the infrared light is selected to have a smaller size to avoid saturation due to the ambient light; on the other hand, the photodetectors for receiving green light, blue light, white light, etc. may have a larger size to obtain effective reflected light, and may further adopt a process of blocking other light sources, for example, a filter material is adopted to isolate low-frequency infrared light in the environment to obtain a signal with a better S/N ratio.

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 calculation by an Adaptive Filter (Adaptive Filter) or subtraction between PPG signals obtained by different light sources, and the like, 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 can comprise at least two impedance detection electrodes which are arranged on the trunk, such as the chest and the abdomen, so as to obtain the impedance signal of the human body, and the impedance change comes from the impedance change of muscle tissues caused by the fluctuation of the chest and/or the abdomen when the human body breathes, so that the sleeping respiration condition can be known by analyzing the impedance change, for example, the existence of the respiration action, the size of the respiration amplitude, the respiration frequency and other respiration related information can be known.

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 respiratory motion, typically in the form of a band around the torso, or alternatively in the form of a patch.

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 may include at least two electrocardiographic electrodes disposed on the trunk, the limbs, etc. to obtain electrocardiographic signals, wherein by analyzing electrocardiographic waveforms, the Heart activity during sleep can be known in detail, for example, accurate Heart Rate variation can be obtained, whether arrhythmia occurs or not can be known, and the Heart Rate Variability (HRV) can be calculated from the Heart Rate to know the activity of the autonomic nerve, which is helpful to further know the physiological status during sleep.

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.

Here, it should be noted that, generally, when acquiring the electrophysiological signals, a signal acquisition electrode and a Right Leg Driver (DRL) electrode are usually disposed, wherein the signal acquisition electrode is used to acquire the electrophysiological signals, and the DRL electrode is used to eliminate common mode noises (e.g. 50Hz/60Hz power noise) and/or provide a Body Potential Level (Body Potential Level) to match with the circuit reference Potential.

In addition, generally, the electrodes are divided into two types, namely a Wet Electrode (Wet Electrode) and a Dry Electrode (Dry Electrode), wherein the Wet Electrode is an Electrode that needs to be brought into sampling contact with the skin of the human body through a conductive medium, for example, a conductive paste, a conductive adhesive, a conductive liquid, etc. are commonly used as the conductive medium, most commonly, a cup-shaped Electrode that needs to be provided with the conductive paste, and an Electrode patch that is formed with the conductive adhesive in advance; on the other hand, the dry electrode does not need a conductive medium, and may be implemented to obtain an electrical signal by directly contacting with the skin, or may be implemented in a non-contact manner, such as a capacitive electrode, an inductive electrode, or an electromagnetic electrode, and may be made of a variety of materials, for example, a conductive material known to sense a spontaneous potential difference of a human body may be used as the dry electrode, such as metal, conductive fiber, conductive rubber, conductive silicone, and the like. The electrodes usually disposed on the surface of the housing are usually in the form of dry electrodes to simplify the operation procedure.

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 light, electrical stimulation, vibration, etc., or any other alert that may be applied to notify the user, wherein the use of tactile alerts is preferred to utilize a vibrating motor 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 alerts (air or bone), or LEDs for visual alerts.

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 (Bluetooth), Low Energy Bluetooth (BLE), Zigbee, WiFi, or other communication protocols, or may be implemented as a wired communication module, such as a USB interface, a UART interface, for communicating in the system and/or with an external device, wherein the external device may include, but is not limited to, a smart device, such as a smart phone, a smart bracelet, smart glasses, smart headphones, or the like, a tablet computer, a laptop 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 feedback information, remote control, and monitoring.

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 signal is acquired by the electro-ocular electrode, and the acquired position is the forehead area 201.

The electromyographic signals are acquired by electromyographic electrodes at various positions, for example, a forehead region 201 and a 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 tactile warning unit providing the vibration warning may be disposed at any position where the body can sense the vibration, and the auditory warning unit providing the sound warning may be preferably disposed near the ear, for example, in the ear canal and the ear canal orifice when the air conduction sound warning is employed, and in the bone conduction sound warning, the setting range may be wide, the entire skull except near the ear may be the setting range, preferably, there is no hair, and the warning may be provided in a single form, or 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 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 form of wearing structure.

As can be seen from the above, even if the same type of physiological information is used, it is possible to obtain the same physiological information without limitation by using different types of physiological sensors and selecting different body regions, and in addition, it is possible to select two or more types of physiological sensors to be used simultaneously and/or to obtain two or more types of physiological information 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.

Where PPI is defined as the time difference between two consecutive peaks in the PPG signal, as shown in fig. 6. First, the peak value (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) are 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.amp and valley.amp points are detected as local maximum and minimum points of the PPG signal, and if a missing peak.amp point occurs, the immediate 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 value due to one of the values not being seen, and further, if there are any abnormal 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 wave area can be calculated from each pulse wave 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 that reflect 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 terms of the present application are defined as follows:

sleep physiological information, comprising at least: sleep posture-related information, sleep stage, sleep physical activity, blood oxygen concentration, heart rate, respiratory action, respiratory frequency, respiratory amplitude, respiratory airflow variation, respiratory behavior, respiratory sound variation, snoring-related information, electrocardiosignals, electroencephalogram signals, electrooculogram signals, and electromyogram signals.

Sleep breathing physiological information, comprising at least: blood oxygen concentration, heart rate, respiratory motion, respiratory frequency, respiratory amplitude, respiratory airflow change, respiratory behavior, respiratory sound change and snoring 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 application provides a sleep apnea physiological feedback training based on sleep respiration events, and fig. 3 shows a schematic flow chart of improving sleep apnea by using the sleep apnea 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 sense, tactile sense, visual sense and the like, so that a user is aroused by a part (awaken) or an arousal (arous al) 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 acquired sleep respiratory physiological information, the intensity of the alarm is increased at the next sleep apnea/hypopnea.

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 may be preloaded in the wearable device for obtaining sleep physiological information, or preloaded in an external device, such as an intelligent device, e.g., a smart phone, a smart bracelet, smart glasses, a smart headset, a tablet computer, a notebook computer, or a personal computer, 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 and manually entered 318 by the user or practitioner 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 containing 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. In 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 in 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 in 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 breathing physiological information and related values from the sampled signal, 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 different signals, the sensor can be installed on the wearable device, or can be installed 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 sleep breathing event index of lying on back to the sleep breathing event index of non-lying on back, or other value, and if the threshold is exceeded, the user is identified as the user of the patient's sleep breathing event, and then Sleep Posture Training (SPT) may be performed at 525, otherwise, the user may perform sleep breathing physiological feedback training based on the sleep breathing event 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 in a preferred embodiment, the present application utilizes the detection of sleep physiological information to understand 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 program decides the alarm behavior according to different alarm condition combinations, therefore, the control unit generates a driving signal according to the alarm behavior, and 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.

In the system of the present application, various software programs are correspondingly provided according to different functions, including, but not limited to, a sleep physiological information analysis program, a sleep respiration event analysis program, an alarm decision program, etc. to obtain various physiological information according to physiological signals obtained by the physiological sensors, and the various software programs can be preloaded in different devices according to different actual requirements and implementations without limitation.

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 application has various implementation possibilities without limitation, and therefore, the above-mentioned various training contents and combinations can be implemented by any suitable embodiments described below, and will not be repeated.

In a preferred embodiment, a sleep physiology system comprises a shell, an adhesive wearing structure for arranging the shell on the trunk of a user, a control unit at least comprising a microcontroller/processor and accommodated in the shell, a communication module electrically connected to the control unit, and a power module, wherein the sleep physiology information is obtained by a posture sensor and a plurality of electrodes electrically connected to the control unit, wherein the posture sensor is used for obtaining sleep posture related information of the user during sleep, the plurality of electrodes are used for obtaining electrocardiosignals of the user during sleep and impedance changes generated by the trunk part of the user, and the sleep physiology system also comprises an information providing interface, for providing information to the user.

Here, particularly, since the installation position is the trunk, the plurality of electrodes can collectively acquire the electrocardiographic signal and the impedance change, and in actual implementation, the electrocardiographic signal can be acquired in a two-pole mode by using two electrodes, and can be acquired in a three-pole mode by adding a DRL electrode, without limitation.

As mentioned above, since the impedance change is caused by the impedance change of muscle tissue caused by the fluctuation of the chest and/or abdomen when the human body breathes, it is able to obtain a lot of physiological information of sleep breathing by analyzing the impedance change, for example, it is able to obtain the breathing action, know whether the fluctuation of the chest and/or abdomen occurs during breathing, also obtain the breathing amplitude change, know the amplitude of the fluctuation of the chest and abdomen during breathing, and also obtain the breathing frequency change. In addition, the cardiac signal can be used to understand the heart activity during sleep, such as heart rate, heart beat variability, arrhythmia, etc.

These sleep apnea physiological information described above are of considerable benefit to the understanding of sleep apnea. As mentioned above, the reason for the obstructive sleep apnea and the central sleep apnea is different, and therefore, it is possible to distinguish whether the breathing action is stopped when the sleep apnea occurs, which is one of the important factors for determining to provide the sleep posture training and/or the sleep apnea physiological feedback training.

In addition, the respiratory amplitude variation, the respiratory frequency variation and the heart rate variation obtained according to the electrocardiosignals can also be used for knowing whether a sleep apnea event and/or a sleep hypopnea event occur to the user, for example, when an obstructive sleep apnea/hypopnea event occurs, the respiratory amplitude is gradually reduced along with the increasingly severe obstruction and then gradually restored until the next respiratory event occurs; in addition, the respiratory rate may rise sharply when a partial arousal or arousal occurs, and then gradually recover until the next respiratory event occurs; the heart rate change will gradually slow as the sleep apnea/hypopnea event occurs and will rise sharply when a partial arousal or arousal occurs, and then gradually resume until the next respiratory event occurs.

Accordingly, by providing a plurality of electrodes, the sleep physiological system of the present application can distinguish whether a sleep apnea/hypopnea event occurs or not, and can also distinguish whether the sleep apnea/hypopnea event is obstructive or central, and further, can further match with the sleep posture related information obtained by the posture sensor to further know whether the sleep apnea/hypopnea event is postural, for example, by comparing the sleep apnea event with the sleep posture related information, to know the distribution status of the sleep apnea events respectively occurring when the sleep apnea/hypopnea event meets a preset posture range and when the sleep apnea/hypopnea event exceeds the preset posture range, and to obtain the sleep apnea event posture related information, such as a posture related sleep apnea index, the number of times of posture related sleep apnea events, and the duration of posture related sleep apnea events, it is helpful to understand the relationship between the occurrence of sleep disordered breathing and the sleep posture more deeply, and then provide the user through the information providing interface. This is advantageous in that a single system setup and a single use can allow complete insight into sleep apnea/hypopnea.

Here, the information providing interface may be implemented as an LED disposed on the housing, for example, or an external device communicating with the control unit through the communication module, for example, an LED, an LCD, a speaker of a smart device or a computer device, and various implementations are possible without limitation.

Furthermore, when the posture sensor is implemented as an accelerometer, it is advantageous to further obtain information related to snoring by detecting body cavity vibration caused by snoring, which is equal to information related to snoring, another common sleep disordered breathing, and to obtain the relationship between the occurrence of snoring and the sleep posture, such as the posture-related snoring index, the number of posture-related snoring, the duration of posture-related snoring, etc., and to use the accelerometer to detect snoring without being affected by external environmental sounds, and to perform detection normally even in a case where the snoring is shielded by clothes or cotton, such as when the sensor is placed on the torso, which is an advantageous option, and to obtain other physiological information related to sleep, such as breathing for comparison with the breathing obtained by impedance change, sleeping physical activity may provide information about the sleep stage/state. Alternatively, the above-mentioned various physiological information may be obtained by additionally providing an accelerometer, without limitation.

Then, further, an alarm unit, such as a tactile alarm unit, may be added to provide sleep posture training and/or sleep breathing physiological feedback training. For example, the obtained sleep posture related information may be compared with a preset posture range, and when the preset posture range is met, an alert behavior may be determined, and an alert may be provided, for example, a vibration alert, to perform sleep posture training; or the obtained sleep breathing physiological information, such as breathing action, breathing amplitude, breathing frequency, heart rate, snoring related information and the like, can be compared with a preset condition, and when the preset condition is met and the warning behavior is determined, a warning is provided, such as a vibration warning, so as to execute the 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. There are various implementation possibilities, without limitation.

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.

Thus, in addition to a detailed understanding of the sleep apnea/hypopnea occurrence in a single system, an improved training program is provided, which is fully functional and an advantageous choice for the user.

In the case of the electrode embodiments, there are likewise a multiplicity of possibilities. One of the advantageous options is to use a patch type electrode, as is well known, which is a common electrode formed with a conductive adhesive in advance, and through the conductive adhesive, the electrode can be stably adhered to the skin surface, so that, by the adhesion property, the patch type electrode can be further implemented as the adhesion type wearing structure of the carrying case, that is, the patch type electrode is implemented as the electrode and the adhesion type wearing structure at the same time, in this case, as shown in fig. 8A, the case 800 only needs to be implemented to be combined with the patch type electrode 801, which is quite convenient, for example, the common implementation form of the patch type electrode is a button fastening form, for example, a protruding male fastening end, so that the case can form a corresponding button fastening structure, for example, a female fastening end that is recessed, so that the electrical connection between the electrode and the control unit can be simultaneously achieved, and the mechanical connection between the shell and the wearing structure is quite convenient. It should be noted that the patch type electrode may be implemented in a form of one electrode and one patch, and may also be implemented in a form of a plurality of electrodes and one patch, and may be changed according to actual requirements without limitation.

Another advantageous option is to dispose the electrodes on the skin-contacting surface of the adhesive wearing structure, since the adhesive wearing structure is configured to carry the housing and is configured to be disposed on the skin surface of the trunk, it is convenient to dispose the electrodes and the housing simultaneously in a single disposing operation if the electrodes can be directly disposed on the skin-contacting surface of the wearing structure. In practical implementation, the at least two electrodes are disposed on the lower surface of the adhesive wearable structure and electrically connected to the control unit in the housing, where the electrodes may be wet electrodes or dry electrodes, where, as shown in fig. 8B, the electrode 802 is formed on the lower surface of the wearable structure, and a conductive medium, such as a conductive adhesive, is disposed thereon, and at this time, the conductive medium may be directly used to provide an adhesive function for fixing, and an adhesive substance may be disposed at a position other than the electrodes to increase the adhesive force, such as an adhesive; when the dry electrode is implemented as a dry electrode without a conductive medium, in order to ensure stable contact between the electrode and the skin, different embodiments may be adopted, as shown in fig. 8C, the wearing structure is provided with a coupling member 803 for coupling with at least two dry electrodes 804, for example, the coupling member forms a concave coupling structure corresponding to a convex coupling structure on the dry electrode, in this case, since the dry electrode can be fixed separately, for example, by using an adhesive tape, stable contact with the skin is possible, and even if the wearing structure moves, the stable contact is not affected.

Here, whether in the form of a wet electrode or a dry electrode, the housing and the wearing structure may be further removably implemented, and thereby it is possible to change the electrodes, for example, by changing the wearing structure to change the distance between the electrodes and/or the distribution position of the electrodes, or to change the type of the electrodes, such as changing the dry electrode to the wet electrode, or to change the electrode to a new one, such as changing the wet electrode when the conductive adhesive of the wet electrode loses its adhesiveness, and thus, there are various possibilities without limitation.

Alternatively, the electrodes and the adhesive wearing structure may be implemented independently of each other, for example, the adhesive wearing structure is used to set the housing, and the electrodes extend from the housing by using the wires and then are fixed, which is also feasible, without limitation.

In another preferred embodiment, a sleep physiology system comprises a housing, an earplug-type wearing structure for disposing the housing on an ear of a user, a control unit comprising at least a microcontroller/processor and accommodated in the housing, a communication module electrically connected to the control unit, and a power module, and further comprises at least a physiological sensor electrically connected to the control unit for obtaining at least a sleep physiology information of the user during sleep, and an audible alarm unit electrically connected to the control unit for generating at least an audible alarm.

Firstly, based on the earplug type wearing structure, the ears are the main setting positions and are very suitable for providing warning by sound, therefore, the warning form adopts auditory warning, the setting steps are simplified, the use is convenient, and in implementation, sound can be generated by a sound generating element, such as a loudspeaker, a buzzer and the like.

Furthermore, the at least one sleep physiological information may be implemented to include sleep posture related information and/or sleep respiration physiological information, and accordingly, the at least one physiological sensor may have many implementation possibilities, for example, a light sensor may be used to obtain sleep respiration physiological information such as heart rate and/or blood oxygen concentration at an ear; or various sleep physiological information such as sleep posture related information, snoring related information and/or heart rate can be obtained on the ears by utilizing the accelerometer; or the microphone can be used for acquiring the information related to snoring and/or the sleep breathing physiological information such as breathing sound change and the like on the ear; in addition, two or more physiological sensors may be provided at the same time, for example, the sleep posture information and the snoring information are acquired by an accelerometer, and the heart rate and/or the blood oxygen concentration are acquired by the optical sensors. Thus, there are various possibilities, without limitation.

According to the above-mentioned sleep physiological information, for example, it can be known whether the sleep posture of the user is lying on the back and/or not during sleep, and whether the user has sleep breathing events during sleep, such as blood physiological sleep breathing events, snoring events, etc., which are the basis for performing the sleep posture training and the sleep breathing physiological feedback training, and it can be matched with the auditory alarm unit arranged in the system to provide auditory alarm according to whether the sleep posture related information conforms to a preset posture range and/or whether the obtained sleep breathing physiological information conforms to a preset condition, i.e. it can be selected to perform only the sleep posture training or the sleep breathing physiological feedback training, or both, so that the single sleep physiological system arranged on the ear can provide multiple functions, including, but not limited to, detection of sleep posture, assessment of the presence or absence of sleep disordered breathing, and provision of sleep posture training and/or sleep breathing physiological feedback training, the achievement of a very simple but also very powerful sleep physiological system.

Here, similarly, the auditory alert is provided such that the control unit is configured to generate a driving signal, and the auditory alert unit generates at least one auditory alert after receiving the driving signal, and provides the at least one auditory alert to the user, so as to achieve the purpose of sleep posture training and/or sleep respiration physiological feedback training, wherein the driving signal is implemented as described above, and is generated at least according to an auditory alert behavior determined when the at least one sleep physiological information is compared with a preset posture range and/or a preset condition, and the preset posture range is met and/or the preset condition is met.

It should be noted that the above-mentioned circuit configurations of the embodiments can be applied to the devices, and the embodiments can be changed according to the physiological information to be obtained and the installation location, and they are not listed based on the principle of not repeated descriptions, but the scope of the claims of the present application is not limited thereby.

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

The above detailed description does not limit the scope of the present invention. Those skilled in the art will appreciate that various modifications, combinations, sub-combinations, and substitutions can occur, depending on design requirements and other factors. Any modification, equivalent replacement, and improvement made within the spirit and principle of the present invention should be included in the protection 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;

a posture sensor electrically connected to the control unit;

a plurality of electrodes electrically connected to the control unit;

a communication module electrically connected to the control unit;

a power module; and

an adhesive wearing structure for arranging the shell on a trunk of a user,

wherein the content of the first and second substances,

the posture sensor is constructed to acquire the sleep posture related information of the user during sleep; and

the plurality of electrodes are configured to acquire a cardiac signal of the user during sleep and to acquire an impedance change of a torso portion of the user during sleep,

wherein the content of the first and second substances,

the impedance variation is further used as a basis to obtain at least one sleep respiration physiological information of the user during sleep, and the at least one sleep respiration physiological information comprises at least one of the following information: respiratory motion, respiratory frequency, and respiratory amplitude, and

wherein the content of the first and second substances,

the system is configured to determine a sleep breathing event of the user during the sleep session based on the at least one sleep breathing physiological information; and

the system is further configured to determine a distribution of the sleep breathing events when the sleep posture related information conforms to a predetermined sleep posture range and when the sleep posture related information exceeds the predetermined sleep posture range, and generate a sleep breathing event posture related information accordingly, and

wherein the content of the first and second substances,

the system also includes an information providing interface for providing the sleep respiratory event posture-related information to the user.

2. The system of claim 1, further comprising at least one alert unit for providing at least one alert, and further comprising an alert decision routine for deciding an alert behavior based on the sleep posture related information and/or the sleep breathing event, and the alert unit generating the at least one alert based on the alert behavior and providing the alert to the user.

3. The system of claim 1, wherein the system is further configured to derive the sleep apnea event as an obstructive sleep apnea event or a central sleep apnea event based on the respiration activity and the respiration amplitude.

4. The system of claim 1, wherein the plurality of electrodes are implemented to be disposed on the adhesively-worn structure.

5. The system of claim 1, wherein at least one of the plurality of electrodes is configured to simultaneously acquire the cardiac signal and the impedance change.

6. The system of claim 1, further comprising an accelerometer to obtain at least one of the following physiological information, comprising: snoring physiological information, respiratory motion, and sleep physical activity information.

7. The system according to claim 6, wherein the attitude sensor is implemented as the accelerometer.

8. The system of claim 1, wherein the system is further configured to derive at least one of the following from the cardiac electrical signal, including: heart rate, rate of heart beat variability, and cardiac arrhythmias.

9. A sleep physiology system, comprising:

a housing;

at least one physiological sensor electrically connected to the control unit;

an auditory alarm unit electrically connected to the control unit for generating at least one auditory alarm;

a communication module electrically connected to the control unit;

a power module; and

an earplug wearing structure for disposing the shell on an ear of a user,

wherein the content of the first and second substances,

the at least one physiological sensor is configured to acquire at least one sleep physiological information of the user during sleep, and the at least one sleep physiological information includes at least one of the following: sleep posture related information, and sleep breathing physiological information; and

the control unit is configured to generate a driving signal, and the warning unit generates the at least one audible warning after receiving the driving signal and provides the at least one audible warning to the user, wherein the driving signal is further implemented to be generated according to an audible warning behavior determined when the at least one sleep physiological information is matched with a preset posture range and/or a preset condition after being compared with the preset posture range and/or the preset condition.

10. The system of claim 9, wherein the at least one physiological sensor is implemented as an accelerometer to obtain at least one of the following sleep physiological information, comprising: sleeping position, snoring related information, and heart rate.

11. The system of claim 9, wherein the at least one physiological sensor is implemented as an optical sensor for acquiring at least one of the following sleep physiological information, comprising: blood oxygen concentration, and heart rate.

12. The system of claim 9, wherein the at least one physiological sensor is implemented as a microphone to obtain at least one of the following sleep physiological information, comprising: snoring related information, and respiratory sound changes.

13. The system of claim 9, wherein the ear-worn structure is implemented with an entrance to the ear canal portion.

14. The system of claim 9, wherein the sleep physiology system is implemented as a wireless headset.

15. The system of claim 9, further comprising an information providing interface for providing at least the at least one physiological information to the user.