WO2023278636A1

WO2023278636A1 - Systems, methods, and components thereof relating to positional therapy for sleep apnea

Info

Publication number: WO2023278636A1
Application number: PCT/US2022/035604
Authority: WO
Inventors: Amir Reuveny; Ahud Mordechai; Mordechai PERLMAN; Nathan Harold BENNETT
Original assignee: Wesper Inc.
Priority date: 2021-06-30
Filing date: 2022-06-29
Publication date: 2023-01-05
Also published as: CA3222817A1

Abstract

Methods and systems for positional sleep therapy for sleep apnea and other disorders are disclosed. A method may include receiving first data indicative of a person's sleeping position from a first sensor and receiving second data indicative of a respiratory condition, a cardiac condition, a snoring condition, and/or an SpO2 level from a second sensor. The method may further include calculating a position-based risk value from the first data and calculating at least one biometric-based risk value from the second data. The method may further include comparing the calculated risk values to at least one threshold risk value to determine if at least one wake rule has been triggered. If at least one wake rule has been triggered, a stimulation component may be commanded to impart a wake stimulation to the person.

Description

SYSTEMS, METHODS, AND COMPONENTS THEREOF RELATING TO POSITIONAL THERAPY FOR SLEEP APNEA

[001] This application claims priority to U.S. Provisional Patent Application Ser. No. 63/217,003, filed on June 30, 2021, and Provisional Patent Application Ser. No 63/328,848, filed April 8, 2022, the disclosures of which are hereby incorporated by reference in their entireties.

TECHNICAL FIELD

[002] This application relates to systems, methods, and components thereof to detect, prevent, mitigate and/or treat sleep disorders, including, but not limited to, sleep apnea. More specifically, this disclosure relates to detecting, preventing, and/or mitigating episodes of positional sleep apnea, hypopnea, snoring disorders, and/or the like. The teachings of this disclosure may also be applicable to medical conditions outside the sleep disorder context, as well as to other sleep-related contexts.

BACKGROUND

[003] “Sleep apnea involves brief pauses in breathing. The most common form of sleep apnea is obstructive sleep apnea. Obstructive sleep apnea occurs when the soft tissues of the upper airway and tongue relax during sleep. When the tissues and muscles relax, they can block the flow of air into the lungs. ... Positional obstructive sleep apnea occurs when the majority of apneic episodes can be attributed to sleep position. When you are in a supine sleep position, lying flat on your back, the shape and size of your upper airway are altered. This sleep position, combined with gravity, increases the likelihood of obstructing the airway. ... It is thought that about 50 percent of people with obstructive sleep apnea have positional obstructive sleep apnea.”

[004] Many instances of positional sleep apnea may be avoided, mitigated, and/or prevented by having a suffering individual avoid and/or minimize sleeping in certain positions which increase the risk of apneic episodes, including, but not limited to, a supine position.

[005] One existing system, NightBalance by Philips, encourages side-sleeping by gently vibrating when an individual is on her back. The NightBalance system comprises a palm-sized, rechargeable device that is positioned on an individual’s chest with a soft, adjustable strap. It is believed that the device uses one or more basic positional sensors to determine patient position.

[006] The NightBalance system has several drawbacks: First, because it relies solely (or substantially) on position to initiate vibrations, the NightBalance system may regularly wake patients when no positional sleep apnea episode had begun or was likely to occur. Second, the NightBalance device and adjustable strap may hinder sleep because some individuals may find the system uncomfortable. Third, the NightBalance device may preclude prone ( e.g ., chest- down) sleeping due to its requisite position.

SUMMARY

[007] The present disclosure provides a description of algorithmic methods, apparatuses, systems, and software to address the perceived problems described above. In some embodiments, one or more monitoring devices that collect biometric data, audio data, and/or position data may be affixed to an individual; such data may be processed and evaluated to assess sleep apnea episode risk; and, where appropriate, the individual may be provided with tactile, electrical, and/or audio stimulation to interrupt apneic, near apneic, and/or otherwise disordered sleep.

[008] In some embodiments, at least one non-transitory computer readable storage medium storing a computer program is provided. When executed by a computer, for example, on a server, smart phone, PC, monitoring device, and/or tablet, the computer program(s) may perform the algorithm embodiments described herein, or a relevant portion thereof. It is to be understood that the descriptions herein are exemplary and explanatory only and are not restrictive of the inventive concepts disclosed.

[009] In one example, a method of improving sleep quality utilizing at least one monitoring device affixed to a person is provided. The at least one monitoring device may include a first sensor, a second sensor, and a stimulation component. The method may include receiving first data indicative of the person’s position from the first sensor. The method may further include receiving second data indicative of a respiratory condition of the person, a cardiac condition of the person, and/or a snoring condition of the person from the second sensor. The method may further include calculating a position-based risk value from the first data. The method may further include calculating at least one biometric-based risk value from the second data. The at least one biometric-based risk value may include a respiratory quality-based risk value, a cardiac quality-based risk value, and/or a snoring condition-based risk value. The method may further include comparing the risk values to at least one threshold value to determine if at least one wake rule has been triggered. If it has been determined that at least one wake rule has been triggered, the method may include commanding the stimulation component to impart a wake stimulation to the person.

[010] The step of comparing the risk values to at least one threshold value to determine if at least one wake rule has been triggered may include comparing the at least one biometric-based risk value to a threshold biometric risk value to determine if at least one wake rule has been triggered, and/or comparing the position-based risk value to a threshold position-based risk value to determine if at least one wake rule has been triggered. [Oil] The step of comparing the risk values to at least one threshold value to determine if at least one wake rule have been triggered may include calculating an overall risk value by combining the position-based risk value and the at least one biometric-based risk value, and comparing the overall risk value to a threshold overall risk value to determine if at least one wake rule has been triggered.

[012] The step of receiving first data may include receiving, from the first sensor, first data indicative of degree of supine position of the person. The step of calculating the position-based risk value may include incorporating first data portions indicative of a degree of supine position of < 45° only if the person maintains such position for a minimum time duration. The minimum time duration may be at least 5 seconds. The step of calculating the position-based risk value may include aggregating incorporated first data portions from a recent time period.

[013] The step of receiving second data may include receiving, from the second sensor, second data indicative of respiratory airflow and/or respiratory pressure. The step of calculating the least one biometric-based risk value may include calculating a respiratory quality-based risk value based on a decrease in respiratory airflow from a respiratory airflow baseline and/or a decrease in respiratory pressure from a respiratory pressure baseline. The step of calculating the least one biometric-based risk value may include calculating a respiratory quality-based risk value based on an increase or decrease in breaths per minute from a breaths per minute baseline.

[014] The step of receiving second data may include receiving, from the second sensor, second data indicative of respiratory effort. The step of calculating the least one biometric-based risk value may include calculating a respiratory quality-based risk value based on an increase or decrease in at respiratory effort from a respiratory effort baseline. [015] The step of receiving second data may include receiving, from the second sensor, second data comprising recorded snoring sounds and/or snoring vibrations. The step of calculating the least one biometric-based risk value may include calculating a snoring condition- based risk value based on snoring loudness, snoring duration, snoring pitch, and/or snoring pattern.

[016] The step of receiving second data may include receiving, from the second sensor, second data indicative of the person’s pulse. The step of calculating the least one biometric- based risk value may include calculating a cardiac quality-based risk value based on an increase or decrease in beats per minute from a beats per minute baseline.

[017] The method may further include imparting the wake stimulation if and only if it the stimulation component has been commanded to impart the wake stimulation. The wake stimulation may include vibrating the at least one monitoring device, providing electrical stimulation, and/or providing an audible alert.

[018] The method may further include imparting the wake stimulation if and only if it the stimulation component has been commanded to impart the wake stimulation. The at least one monitoring device may include a smart phone. The smart phone may impart the wake stimulation via vibration and/or audible alert.

[019] In another example, a method of improving sleep quality utilizing at least one monitoring device affixed to a person is provided. The at least one monitoring device may include a first sensor, a second sensor, and a stimulation component. The method may include receiving first data indicative of the person’s position from the first sensor. The method may further include receiving second data indicative of a respiratory condition of the person, a cardiac condition of the person, a snoring condition of the person from the second sensor, and/or a blood oxygen saturation condition of the person. The method may further include calculating a position-based risk value from the first data. The method may further include calculating at least one biometric-based risk value from the second data. The at least one biometric-based risk value may include a respiratory quality-based risk value, a cardiac quality-based risk value, a snoring condition-based risk value, and/or a blood oxygen saturation-based risk value. The method may further include comparing the risk values to at least one threshold value to determine if at least one wake rule has been triggered. If it has been determined that at least one wake rule has been triggered, the method may include commanding the stimulation component to impart a wake stimulation to the person.

[020] The step of receiving second data may include receiving, from the second sensor, second data indicative of Sp02 levels of the person. The step of calculating the least one biometric-based risk value may include calculating a blood oxygen saturation-based risk value based on a decrease in Sp02 levels from a Sp02 baseline and/or a determination that Sp02 levels have fallen below a minimum Sp02 threshold.

BRIEF DESCRIPTION OF THE DRAWINGS

[021] The accompanying drawings, which are incorporated into and constitute a part of this specification, illustrate several embodiments and aspects of the apparatuses and methods described herein and, together with the description, serve to explain the principles of the invention.

[022] FIG. l is a high-level architecture diagram illustrating an exemplary positional sleep therapy system, in accordance with exemplary embodiments.

[023] FIG. 2 is a block diagram illustrating an exemplary mobile device of FIG. 1, in accordance with exemplary embodiments. [024] FIG. 3 is a flow chart of an exemplary method of conducting positional sleep therapy, in accordance with exemplary embodiments.

[025] FIG. 4 is a flow chart of an exemplary positional sleep therapy algorithm, in accordance with exemplary embodiments.

DETAILED DESCRIPTION

[026] Positional Sleep Therapy System 100

[027] FIG. 1 illustrates an embodiment of positional sleep therapy system 100. While the disclosed methods and systems are primarily explained herein in the context of detecting, treating, preventing, and mitigating positional sleep apnea, they are not so limited. That is, the disclosed methods and systems may be embodied in other contexts and technologies, as would be understood by a person of ordinary skill in the art. These contexts expressly include the mitigation, treatment, and/or preventions of sleep hypopnea, excessive snoring, and/or other sleep-related disorders and conditions.

[028] System 100 may include one or more person 105, one or more mobile or computing devices 115, and one or more monitoring devices 101.

[029] Monitoring devices 101 may be configured to attach to a person 105 and obtain positional, biometric, and/or other relevant data therefrom; may be configured to provide tactile, audible, or electric shock feedback to person 105; may be configured to communicate with one or more mobile devices 115 via Bluetooth and/or another wireless or wired communication protocol; and/or may be configured to communicate with one or more other monitoring devices 101 via Bluetooth and/or another wireless or wired communication protocol.

[030] One or more persons 105 may use mobile device 115 running application software and/or a web interface to interact with other components of system 100. In preferred embodiments, mobile device 115 may be a smart phone running, for example, Apple® OS, Android®, or the like. Mobile device 115, discussed in more detail below, however, is not so limited: It may be any type of mobile computing device suitable for performing the functions and algorithms disclosed herein such a smart watch, laptop computer, notebook computer, tablet computer, etc. In alternative embodiments, it may be a computing device that is not mobile. Mobile device 115 may be connected to a network 106, and may connect to server 120 therethrough.

[031] It is contemplated that system 100 may concurrently provide support to multiple persons 105 by interfacing with multiple mobile devices 115 and/or their respective connected monitoring device(s) 101, respectively.

[032] Network 106 may be any type of network suitable for performing the functions disclosed herein as will be apparent to persons having skill in the relevant art; it may include one or more communications technologies, including, but not limited to 3G, LTE, 4G, 5G, WiMax, the Internet, etc.

[033] System 100 may include one or more sleep professionals 103 who may provide data and other input relevant to configuring a positional therapy algorithm for persons 105. Professionals 103 may use computing device 113 running application software and/or a web interface to interact with other components and users in system 100. Computing device 113 may be any type of computing device suitable for performing the functions and algorithms disclosed herein such a desktop computer, laptop computer, notebook computer, tablet computer, smartphone, etc, or laptop, and/or alternatively may be substantially the same as mobile device 115. Computing device 113 may be connected to network 106, and may connect to server 120 therethrough. It is contemplated that system 100 may concurrently provide service to multiple sleep professionals 103 concurrently.

[034] System 100 may include one or more system administrator 107 (not shown). Admin 107 may use computing device 117 (not shown) to access, control, program, enter data in, receive data from, and update server 120 and other system 100 components. Admin 107 is not limited to an individual with an administrator title, but may include any person or group of people using computing device 117 to manage or otherwise directly alter the software structures, functions, or data of server 120. Computing device 117, may be any type of computing device suitable for performing the functions and algorithms disclosed herein such a desktop computer, laptop computer, notebook computer, tablet computer, smartphone, etc. Computing device 117 may be connected to network 106, and may connect to server 120 there through.

[035] Server 120 may substantially comprise the back-end of system 100 and may include and/or access database 140. As would be appreciated by a person of skill in the art, server 120 may be cloud-based, may comprise one or more server 120 installations, and/or may be distributed. Database 140 may be a cloud-based database (as shown in FIG. 1) and/or may be co located with processing elements of server 120.

[036] Server 120 may enable or facilitate data storage and data transmission relating to persons 105; downloading and updating application software; and/or a web interface. Server 120 may additionally comprise a plurality of functional software blocks, to accomplish for example, data intake, anonymization, aggregation, and analysis. In some embodiments, certain functional software blocks of server 120 may interface with one or more third party services directly and/or over network 106 via, for example, API calls or the like to obtain or report sleep data or other information to medical providers, researchers, and/or product developers; facilitate financial transactions; and/or the like.

[037] Mobile/ Computing Devices 113/115

[038] FIG. 2 illustrates an embodiment of mobile and/or computing device 113/115 of system 100. It will be apparent to persons having skill in the relevant art that the embodiment of the device 113/115 illustrated in FIG. 2 is provided as illustration only and may not be exhaustive to all possible configurations of a device 113/115 suitable for performing the functions as discussed herein. Device 113/115 may include a display device 202. The display device 202 may be configured to communicate and/or interface with a display 204 to display data to a user 103/105. The display 204 may be any type of display suitable for performing the functions disclosed herein, such as a liquid crystal display, light-emitting diode display, OLED display, touch screen display, capacitive touch display, etc. The display device 202 may be configured to transmit data to the display that is stored in a memory 206 of the device 113/115.

[039] Device 113/115 may include non-volatile storage 218, which can store software and data that would be apparent to persons having skill in the relevant art.

[040] The display device 202 may be configured to display various interfaces and appropriate data to the relevant user 103/105. The display device 202 may also display a cursor position, which may allow user 103/105 to select an option or a variable, use a dropdown menu, indicate a point of input for text or commands input by the user 103/105, and/or facilitate user communication in another fashion known to persons of skill in the art.

[041] Device 113/115 may receive input from user 103/105 via an input device 208. User 103/105 may communicate with the input device 208 via an input interface 210 that is connected to or otherwise in communication with the input device 208. The input interface 210 may be any type of input suitable for performing the functions disclosed herein, such as a keyboard, mouse, touch screen, click wheel, scroll wheel, trackball, touch bad, input pad, microphone, camera, etc. In some embodiments, the input interface 210 and the display 204 may be combined, such as in a capacitive touch display. In some instances, the display 204 and/or the input interface 210 may be included in the device 113/115. In other instances, the display 204 and/or the input interface 210 may be external to the device 113/115.

[042] Device 113/115 may further include a processing device 212. The processing device 212 may be a central processing unit (CPU) or other processor or set of processors suitable for performing the functions disclosed herein as will be apparent to persons having skill in the relevant art. The processing device 212 may receive data associated with input by a user, such as via the input device 208. The processing device 212 may also be configured to read data and software stored in non-volatile storage 218 and memory 206; write data and software stored in non-volatile storage 218 and memory 206; execute program code stored in the memory 206 or non-volatile storage 218, such as embodiments of the algorithms disclosed herein; communicate to other system 100 components on network 106 via receiving device 216 and transmitting device 214; and transmit data to the display device 202 for display to the user 103/105 via the display 204. The processing device 212 may be further configured to execute embodiments of the algorithms disclosed herein, as discussed in more detail below. Additional functions performed by the processing device 212 will be apparent to persons having skill in the relevant art and may also be discussed herein.

[043] The memory 206 may store data suitable for performing the functions disclosed herein. Some or all of the data and software stored within non-volatile storage 218 may be copied to memory 206 to support the processing functions of processing device 212. [044] Device 113/115 may also include a transmitting device 214. The transmitting device 214 may be configured to transmit data over the network 16 via one or more suitable network protocols. Device 113/115 may also include a receiving device 216. The receiving device 216 may be configured to receive data over the network 110 via one or more suitable network protocols.

[045] It is also specifically contemplated that transmitting and receiving devices 214/216 or at least mobile device 115 are configured to communicate via Bluetooth protocol or the like to exchange data and/or commands with monitoring device 101.

[046] Monitoring Devices 101

[047] With reference to U.S. Patent Nos. 10,531,832 and 10,531,833, and U.S. Patent Pub Nos. 2020/0155071 and 2020/0107782 — which are hereby incorporated herein in their entireties, preferred embodiments of monitoring device 101 may be a patch. In such patch embodiments, monitoring devices 101 may be affixed to an individual’s skin.

[048] Monitoring device 101 may contain various sensors including, but not limited to position sensors; pressure sensors; airflow sensors, pulse sensors; Sp02 sensors; proximity sensors; microphones; bio-impedance sensors; electro-optical sensors comprising, for example, light source and photodetector pairs; electro-mechanical sensors comprising, for example, flexible, conductive sheets; and/or other sensors known in the art to collect other relevant biometric data.

[049] In some embodiments, one or more stimulation components may be integrated into monitoring device(s) 101. Such stimulation components may provide electrical stimulation, for example, akin to a TENS unit; vibration or other tactile stimulation, for example, via a small electric motor; auditory stimulation, for example, via a speaker; a MEMS (micro-electronical mechanical system) device; and/or the like.

[050] A person 105 employing system 100 may utilize one or more monitoring devices 101 concurrently. Each monitoring device 101 being utilized for a single person 105 may transmit and receive data with a paired mobile/ computing device 115 via its communications circuitry (“COM”). Such data may include processed or unprocessed sensor data from monitoring device 101; battery or power consumption data from monitoring device 101; stimulation commands from mobile/ computing device 115; various signal receipt confirmations; and/or the like.

[051] During use, one or more monitoring devices 101 may be attached to an individual 105. The simultaneous use of multiple monitoring devices 101 may serve to provide a more robust or reliable array of sensor data on a person 105, thereby enabling more detailed or reliable sleep or other biometric analysis.

[052] Furthermore, it is contemplated that different types of monitoring devices 101 with varied sensor and/or stimulation component sets may be produced. This may enable the most appropriate sensor(s) and/or stimulation component s) to easily be selected and used in view of the preferences and needs of each person 105 and their particular circumstances. Moreover, the inclusion of an excessive amount of sensor(s) and/or stimulation component(s) may be undesirable in view of the corresponding manufacturing cost, power consumption, size, weight, data processing limitations, sensor interference, and/or the like.

[053] In certain embodiments, for example where multiple monitoring devices 101 are utilized, one or more monitoring devices 101 may contain one or more stimulation components to the exclusion of sensors. In such embodiments, “monitoring device” may be a misnomer and monitoring device 101 may be considered a dedicated wake device. [054] In certain embodiments, for example, where a sensor within mobile device 115 is utilized to capture biometric data, mobile device 115 may additionally be considered a monitoring device 101. For example, a microphone of mobile device 115 may record audio data to assess whether person 105 is snoring and/or the characteristics of such snoring.

[055] In alternative embodiments, one or more monitoring devices 101 may contain sufficient processing circuitry and software to enable data-processing and decision-making without being connected to, communicating with, and/or relying upon mobile/computing device 115 or another external device. In such embodiments, monitoring device(s) 101 may contain additional circuitry and/or software components discussed above with respect to mobile/computing device 115. It is contemplated that in some embodiments where multiple monitoring devices 101 are utilized, one monitoring device 101 may contain additional processing and execution functionality and serve as the “master”; additional monitoring device(s) 101 may be considered “slave(s).” The slave monitoring devices 101 may communicate with the master, with the master collecting data from and issuing commands to the slave(s).

[056] Positional Sleep Therapy Method 300

[057] With reference to FIG. 3, an embodiment of an exemplary positional sleep therapy method 300 is provided.

[058] As in step 305, a person 105 (or other individual) may pair their mobile device 115 with one or more monitoring devices 101 to be used. In preferred embodiments, pairing may comprise Bluetooth pairing, but this disclosure is not so limited.

[059] As in step 310, an optional baseline session may be conducted. A baseline session may be most advantageous the first time person 105 utilizes system 100. In some embodiments, a baseline session may be conducted at a sleep clinic or the like by a sleep professional 103.

During a baseline session, data may be collected for calibration as well as future comparisons. For calibration purposes, thresholds and other algorithm parameters (discussed below) may be adjusted according to this initial baseline session data. For comparison purposes, the efficacy of using of system 100 may later be estimated and/or assessed by comparing subsequent sleep session data to baseline session data; such assessment maybe displayed or otherwise provided to users 105/103.

[060] As in steps 315, 320, and 330, wake rules and thresholds may be configured and/or re configured. In some embodiments, some or all of these wake rules or thresholds may be initially configured automatically, or semi-automatically based upon, for example, baseline session results.

[061] In some embodiments, some or all of these wake rules or thresholds may be set or adjusted by person 105 on mobile/computing device 115 via an application or web-based application interface. Default values may be globally pre-set for some or all wake rules or thresholds.

[062] In certain embodiments, some or all wake rule and/or threshold configurations may be set by a sleep professional 103 or other individual on mobile/computing device 103 via an application or web-based application interface. Such configurations may be uploaded to server 120 and/or stored in database 140, for downloading and use by mobile/computing device 115 via network 106.

[063] As discussed below with reference to Step 390, wake rules and thresholds may be fine- tuned, reconfigured, or otherwise optimized automatically via machine learning algorithms based on historical sleep session data of person 105. [064] As in step 315, wake rules and thresholds may be set with respect to the sleeping position of person 105. For example, thresholds regarding a person’s 105 position may pertain to the degree of supine position and/or the duration of the supine position. In one example of degree of supine position thresholds, 0°-5° may be considered fully supine, 5°-15° may be considered mostly supine, 15°-30° may be considered slightly supine, 30°-45° may be considered nominally supine and, > 45° may be considered (typically desirable) side sleeping — where 0° may be understood as a person 105 being flat on her back. Duration thresholds may account for the amount of time a person 105 is in one or more supine position. For example, a supine position may not need to be accounted for unless it lasts at least 5, 10, 15, or 30 seconds.

[065] Wake rules based on position may refer to the circumstances where a person 105 should be woken up based on a degree of supine position and/or the duration of such position, alone, or in combination with respiration quality data, cardiac signal data, snoring condition data, blood oxygen saturation data, other indicators of apnea or impending apnea, and/or other indicators of ongoing or impending sleep disorder episodes. In one example, it is contemplated that a position-based risk value may be generated based on the degree of a person’s 105 current position and duration thereof — and/or aggregation of such values over a recent time period, for example 30 minutes — to the extent that the degree of a person’s 105 current position and/or duration thereof exceeds minimum thresholds. In one wake rule example, a person 105 may be woken up if the position-based risk value, alone, exceeds a particular threshold. In another wake rule example, person 105 may be woken up if the position-based risk value in concert with other apnea risk values exceeds a particular threshold.

[066] As in step 320, wake rules and thresholds may be set with respect to a person’s 105 respiratory quality signals, cardiac quality signals, and/or Sp02 levels. With reference to, for example, U.S. Patent Nos. 10,531,832 and 10,531,833, and U.S. Patent Pub Nos. 2020/0155071 and 2020/0107782 (which are all incorporated herein by reference in their entireties) mobile/computing device 115 may be configured to analyze and quantify a person 105’s respiratory and cardiac performance based on signals received from monitoring device(s) 101. In some embodiments, various measures of respiratory severity as disclosed in U.S. Provisional Patent Application Ser. No 63/328,848, filed April 8, 2022, may be utilized to quantify a person 105’s respiratory performance.

[067] For example, thresholds regarding person 105’s respiratory condition may correspond to a measure of respiratory quality (and/or stress) and/or the duration of such condition; thresholds regarding person 105’s cardiac condition may include a measure of cardiac signal quality (and/or stress) and/or the duration of such condition; and/or thresholds regarding person 105’s blood oxygen saturation condition may include a Sp02 measurement data and/or the duration of such condition. In some embodiments, thresholds may correspond to a combined measures of respiratory and cardiac quality (and/or stress), the duration of such conditions, and/or oxygen saturation levels (and/or duration(s) thereof).

[068] Respiratory, cardiac, and/or oxygen saturation conditions may be assigned values based on the likelihood that they indicate an ongoing apneic episode, correspond to impending apneic risk, and/or indicate another ongoing or impending disorder or condition. Thresholds values may be set accordingly. In embodiments where person 105 sets one or more such thresholds, the apneic condition or risk level based on respiratory, cardiac, and/or oxygen saturation condition may be described generally — e.g., “severe apnea ongoing,” “moderate apnea ongoing,” “mild apnea ongoing,” “high apneic risk,” “moderate apneic risk,” “mild apneic risk,” etc. It is contemplated that such descriptions may correspond to objective numerical thresholds such as, for example, a measurable decrease in oxygen saturation levels

(e.g., >3%, >4%, >5%, >10%, >15%, >20%, and/or the like); an independent measure of oxygen saturation levels (e.g., <95%, <90%, <85%, <80%, <75%, and/or the like); an increase or decrease in pulse rate (e.g., > 5 beats per minute (bpm) , >10 bpm, >15 bpm, >20bpm, >25bpm, >30bpm and/or the like); an increase or decrease in respiration rate (e.g., 2 breaths per minute (brpm), 3 brpm, 4 brpm, 5 brpm, 6 brpm, >6 brpm and/or the like), an increase or decrease increase in respiratory effort

(e.g., >10%, >20%, >30%, >50%, >80%, >100%, >150%, >200%, and/or the like); a decrease in respiratory airflow / pressure (e.g., >10%, >20%, >30%, >50%, >80%, >90%, >100%) and/or a combination thereof.

[069] Additionally, or alternatively, such numerical thresholds may be, for example, set as global defaults, set as defaults specific to certain person characteristics, and/or set or modified by sleep professional 103 for a particular person 105. As discussed in, for example, US 10,531,862, respiratory effort data may be derived from monitoring device(s) 101 that measure bodily movement, e.g., of the thorax of person 105, during respiration activities. It is also contemplated that in certain preferred embodiments, a measure of oxygen saturation below 90% (or an approximation thereof) may be considered automatically triggering.

[070] It is contemplated that, in various embodiments, increases or decreases in percentages or beats/breaths per minute may be calculated based off of previously set baselines for person 105, baselines set based on data from the immediately prior sleep session, baselines set based on data from multiple prior sleep sessions, baselines set based on data from the entirety of the current sleep session, and/or baselines set from a portion of the current sleep session (e.g., the previous 30 minutes, the prior hour, the prior two hours, and/or the like). [071] Additionally, respiratory, cardiac, and/or oxygen saturation conditions may be assigned values based on the likelihood that they indicate another ongoing problematic sleep condition (whether in addition to or distinct from apnea) or correspond to impending risk thereof. Such problematic sleep conditions may include, but are not limited to hypopnea, excessive snoring, pain, an elevated heart rate, and/or the like.

[072] Wake rules based on respiratory, cardiac, and/or Sp02 signals may refer to the circumstances where a person 105 should be woken up based on respiratory and/or cardiac condition and/or the duration of the such condition(s), alone, or in combination with position data, snoring condition data, and/or other indicators of existing or impending apnea. In one example, it is contemplated that a respiratory/cardiac/Sp02 quality-based apnea risk value may be generated based on a current measure of respiratory/cardiac quality and/or duration thereof — and/or aggregation of such values over a recent time period, for example, 30 minutes — to the extent that the respiratory/cardiac/Sp02 quality-based apnea risk value and/or duration thereof exceeds thresholds. In one wake rule example, a person 105 may be woken up if the respiratory/cardiac quality-based apnea risk value, alone, exceeds a particular threshold. In another wake rule example, person 105 may be woken up if the respiratory/cardiac quality -based apnea risk value in concert with other apnea risk values, exceeds a particular threshold.

[073] As in step 330, wake rules and thresholds may be set with respect to a person’s 105 snoring. It is contemplated that snoring sounds and/or duration may be measured via a microphone on mobile/computing device 115, and/or a microphone and/or other suitable vibration sensor in monitoring device(s) 101. A person’s snoring may be quantified by loudness (e.g., decibels), duration, pitch, and/or pattern. Mobile/computing device 115 may be configured to analyze and quantify a person 105’s snoring based on one or more of such characteristics. [074] Thresholds regarding person 105’s snoring condition may, for example, correspond to a measure of snoring loudness, duration, pitch, and/ or pattern. Snoring signals may be assigned values based on the likelihood that they indicate an ongoing apneic episode, correspond to impending apneic risk, and/or the like. Thresholds values may be set accordingly. In embodiments where person 105 sets one or more such thresholds, the snoring condition may be described generally — e.g., “severe snoring,” “moderate snoring,” “mild snoring,” “high apneic risk,” etc.

[075] Wake rules based on snoring condition may refer to the circumstances where a person 105 should be woken up based on snoring condition data, alone, or in combination with position data, respiration quality data, cardiac signal data, and/or other indicators of apnea or impending apnea. In one example, it is contemplated that a snoring condition-based risk value may be generated based on a current measure of snoring condition thereof — and/or aggregation of such values over a recent time period, for example, 30 minutes — to the extent that the snoring condition-based risk value and/or duration thereof exceeds thresholds. In one wake rule example, a person 105 may be woken up if the snoring condition-based apnea risk value, alone, exceeds a particular threshold. In another wake rule example, person 105 may be woken up if the snoring condition-based risk value in concert with other risk values, exceeds a particular threshold.

[076] As in step 340, monitoring device(s) 101 may be adhered to person 105’s body in appropriate positions.

[077] As in step 345, position calibration of monitoring device(s) 101 may optionally proceed. In one embodiment, person 105 may attempt to lie as flat on her back as possible. Achievement of a fully supine position may then be indicated automatically and/or via manual or auditory input to mobile/computing device 115 for calibration. With reference to the positional measurements discussed above, mobile/computing device 115 may consider this calibrated position to be 0°. In another embodiment, position calibration may comprise of calibrating to position data received while person 105 is directed to (i) stand up and bend forward, (ii) rotate from left to right (or vice versa) while lying down, and/or the like. As one of ordinary skill in the art would appreciate, many suitable methods of calibration may exist.

[078] As in step 350, device 115 may run the positional therapy algorithm. FIG. 4 depicts a flow chart of an exemplary positional therapy algorithm 350. For exemplary purposes, sub-steps of step 350 are discussed with reference to apnea risk values. However, this disclosure is not so limited: The additional or alternative calculation and utilization of risk values pertaining to other disorders and/or problematic sleep conditions are specifically contemplated.

[079] With reference to FIG 4, as in step 351, mobile/computing device 115 may receive sensor data from monitoring devices(s) 101. Such data may be processed, unprocessed, or partially processed prior to transmission. As discussed above, although Bluetooth protocols may be preferred, the sensor data may be communicated to mobile/computing device 115 via any suitable wireless or wired communications interface.

[080] As in step 353, mobile/computing device 115 may collect auditory data via its microphone. In some alternative embodiments, such auditory data may be collected from a microphone that is not contained within mobile/computing device 115 or any monitoring device 101; such external microphone may transmit its auditory data to mobile/computing device 115 via a wireless or wired connection.

[081] As in step 361, mobile/computing device 115 may calculate a position-based apnea risk value(s) based on the current and/or previously received sensor data from monitoring device(s) 101 that are indicative of person 105’s sleeping position (and as described above with reference to step 315).

[082] As in step 363, mobile/computing device 115 may calculate a respiratory quality -based apnea risk(s) value based on the current and/or previously received sensor data from monitoring device(s) 101 that are indicative of person 105’s respiratory activity (as described above with reference to step 320).

[083] As in step 365, mobile/computing device 115 may calculate a cardiac quality -based apnea risk(s) value based on the current and/or previously received sensor data from monitoring device(s) 101 that are indicative of person 105’s cardiac activity (as described above with reference to step 320).

[084] As in step 366, mobile/computing device 115 may calculate an oxygen saturation- based apnea risk(s) value based on the current and/or previously received sensor data from monitoring device(s) 101 that are indicative of person 105’s Sp02 levels (as described above with reference to step 320).

[085] As in step 367, mobile/computing device 115 may calculate a snoring condition-based apnea risk(s) value based on the current and/or previously received sensor data from monitoring device(s) indicative of person 105’s snoring condition; the current and/or previously captured auditory data from mobile/computing device 115 microphone; and/or current and/or previously captured microphone data from an external microphone (as described above with reference to step 330). In alternative embodiments, snoring data may be incorporated in calculating a respiratory -based risk value, as in step 363.

[086] As in step 370, mobile/computing device 115 may determine whether the apnea risk value(s) — individually or collectively — exceed corresponding threshold value(s) such that a wake-up event should be triggered. If, based on the calculated apnea risk value(s) when analyzed in light of previously configured threshold value(s) and/or wake-up rule(s) (as described above with reference to steps 315, 320, and 330), it may be determined that person 105 is likely having or about to have an apneic episode and/or other problematic sleep condition, such as, hypopnea, excessive snoring, pain, an elevated heart rate, and/or the like. In such circumstances, a wake-up stimulation may be deemed appropriate and the algorithm 350 may proceed to step 375. If, however, no wake rule is triggered, algorithm 350 may loop back to step 351.

[087] As in step 375, mobile/computing device 115 may send a command to one or more monitoring devices 101 — including in some embodiments, one or more dedicated wake devices — to trigger their respective stimulation component s).

[088] Upon receiving a wake command a stimulation component may, as appropriate, impart electrical stimulation to person 105, vibrate, generate auditory stimulation, and/or the like. Additionally or alternatively to sending stimulation commands to monitoring device(s) 101, mobile/computing device 115 may impart its own wake stimulation(s) to person 105 via an auditory alarm, a vibration (e.g., if the mobile/computing device 115 is placed under person 105’s pillow or in a pocket), flashing lights, and/or the like. Other stimulation devices not attached to person 105 or physically integrated with mobile/computing device 115 may also be triggered in certain embodiments.

[089] In certain preferred embodiments, wake up stimulation(s) may continue and/or increase in intensity until one more apnea risk value(s) are sufficiently decreased. In some embodiments, the position-based apnea risk value may be utilized alone or predominately for this purpose.

[090] It is also contemplated that in some embodiments, the initial intensity of wake up stimulation(s) may be increased and/or otherwise altered in each new step 375 iteration based upon person 105’s response(s) to wake up stimulation(s) in previous step 375 iterations. In this manner it is contemplated that a person 105’s optimal simulation level could be determined based on historical sleep session data. For example, if during an earlier iteration of step 375, person 105 was initially provided a relatively low intensity of electrical stimulation and did not sufficiently respond until a relatively high intensity of electrical stimulation was imparted, a subsequent iteration of step 375 may commence with that relatively high intensity of electrical stimulation.

[091] It is further contemplated that, in some embodiments, stimulations may be rendered most effective by optimizing or otherwise modifying parameters of stimulation type(s), stimulation pattern, stimulation duration, stimulation amplitude (e.g., intensity), the timing of stimulation start, and/or the like. Utilization of a stimulation pattern (e.g., a patterned vibration versus a steady “on”), reductions in duration, and reductions in amplitude may beneficially conserve battery life in monitoring devices 101, as well as minimize potential discomfort in person 105. The timing of a stimulation start may consider the degree to which risk values exceed threshold, the degree to which a risk value increases, the confluence of multiple risk values, and/or the like.

[092] Stimulation parameters may be initially set with global default values; person 105- specific default values and / or manually input by person 105 (or sleep professional 103). Person 105-specific default values may be based on gender, sex, age, height weight, relevant medical diagnoses (e.g., specific cardiopulmonary or cardiovascular diseases or categories thereof), and or the like.

[093] Automated optimization of some or all stimulation parameters may proceed by measuring the time between each stimulation and effect — e.g., a wake-up, a cessation of a sleep event, and/or substantial decrease in risk value(s). It is contemplated that a “wake-up” may be determined manually by person 105 (e.g., by pressing a button on a monitoring device 101, on a mobile/computing device 115, and or the like), or by using data inputs from one or more monitoring devices 101 to determine “wake-up” based on body position, rapid body movement, heart rate, breathing rate, EEG, and/or the like. The measurement of response time(s) may be utilized to assess the effectiveness of each stimulation (e.g., based on a particular set of stimulation parameters) and determine whether a change in stimulation parameters may be beneficial.

[094] In various embodiments, stimulation parameter optimization algorithms may be based on the response times to individual stimulations (e.g., if no response to stimulation n within some time, make stimulation n+1 more aggressive) or may be based on an observed distribution of stimulus responses over an amount of time (e.g., 1 or more hours, or one or more sleep sessions). For example, over the course of a full sleep session test, system 100 may consider that if the response time is x seconds or less for at least y% of stimulation events given a minimum total number of z stimulus applications, the stimulation is optimized and needs no further changes. Conversely, as another example, if response times are too short, for example, characterized by less than 2 seconds, less than one second, less than 0.5 seconds, or less than 0.25 seconds, this may suggest that a “wake-up” effect is reached too abruptly; this may suggest, for example, that the simulation has excessive amplitude. In certain embodiments, x may be between 1 and 15 seconds, y may be between 75% and 95%, and z might be between 10 and 25 applications (e.g., 10, 12, 15, 20, 25, and/or the like). Thus, in one example, over the course of a full sleep session test, system 100 may consider that if the response time is 5 seconds or less for at least 90% of stimulation events given a minimum total number of 20 stimulus applications, the stimulation is optimized and needs no further changes.

[095] It is contemplated that, in various embodiments, stimulation parameter optimization routines may begin during the first sleep session (e.g., baseline session 310), or may wait an extended period of time (e.g., a number of hours or number of sleep sessions) before logging or utilizing response time data. Once stimulation parameter(s) are considered optimized, monitoring of response time may continue consistently and/or periodically to ensure stimulation effectiveness.

[096] Positional therapy algorithm 350 may continue to run in a loop until it is halted by, for example, person 105 turning it off after waking up (e.g., via mobile/computing device 115 or removing one or more monitoring devices 101); a malfunction or power shortage; a time-based alarm to wake-up person 105; and/or the like. A time-based alarm to wake-up person 105 may, in some embodiments, utilize one or more wake-up stimulation components in monitoring device(s) 101; a speaker and/or vibration functionality of mobile/computing device 115; an external stimulation device; and or the like.

[097] Turning back to FIG. 3, after positional therapy algorithm 350 is completed, system 100 may prepare a session analysis and report, as in step 380. It is contemplated that an application running on mobile/ computing device 115 may analyze the session data and prepare it in a report for suitable for person 105’s viewing. (In some embodiments, however, some or all session data may be provided to server 120 for analysis and report preparation.) The session data, analysis, and/or report may be uploaded to server 120 and/or stored in database 140. Such processed information may be made available for viewing and further analysis by sleep professional 103 via computing device 113. Such processed information may additionally or alternatively be sent to person 105, sleep professional 103, and/or other entities as appropriate via email, SMS text, or the like.

[098] In preferred embodiments, a session report may comprise a visualization of wake triggers and their impacts on person 105’s sleep quality, sleep duration, apneic episodes, apneic risk, hypopnea episodes, hypopnea risk, snoring episodes, blood oxygen saturation, and/or the like. In some embodiments, a session report may include one or more of Action items (e.g., tips/recommendations); visualization of position/movement, (for example, as shown in U.S. Patent Application No. 29/794,804, filed June 15, 2021, and incorporated by reference herein in its entirety); other biometric signals such as heart rate, breathing rate, Sp02, and/or the like; snoring information/recordings; and/or the like.

[099] Current and historical session data, analysis, and/or reports from multiple persons 105 may be anonymized, further processed, correlated, and/or collectively analyzed to optimize preliminary threshold and wake rule configurations, for example, based on a person’s medical, geographical, and/or demographic characteristics; otherwise improve system 100, including but not limited to its methods, algorithms, and monitoring device(s); and/or to conduct medical/academic/product research on apnea, other relevant sleep anomalies, other medical conditions, and/or potential or existing treatments/therapies thereto.

[0100] As in step 385, person 105 may take necessary steps to reuse the monitoring device, such as replenishing energy sources, replacing perishable elements, and/or the like. For example, in some embodiments, person 105 may re-charge monitoring device(s) 101 and replace their adhesive portions for use in a subsequent session.

[0101] As in step 390 (and/or steps 315, 320, and 330), threshold and rules may be optimized based on session results — automatically, by person 105, and/or by sleep professional 103. Thresholds and rules may be tuned between sessions based on estimations of the effects of previous applications of wake rules and their specific parameters. Such tuning may be effectuated on an event-by-event basis, on a session-by-session basis, and/or based on data from multiple sessions together. Method 300 may substantially be repeated as appropriate.

[0102] Alternative Embodiments

[0103] Outside of the positional sleep apnea context, the above described system 100 may be utilized for other sleep related purposes.

[0104] In one example, system 100 may serve to wake up person 105 via tactile, electric, and/or auditory stimulation, if snoring — or excessively loud snoring, for example, above a particular decibel level — is detected.

[0105] In another embodiment, system 100 may serve to wake up person 105 via tactile and/or electric stimulation, based on time and/or location. In this manner, system 100 may serve as an alarm clock: It may wake up a person 105 without waking their sleeping partner or otherwise causing a disturbance. In some embodiments, location may be determined via a GPS sensor or the like on a mobile device 115; a wake-up stimulation may be triggered based on a person’s geographical approach to a specific travel destination. For example, a traveling person 105 may receive electrical stimulation when they arrive at — or are a set distance from — their train stop or other destination.

[0106] In another embodiment, system 100 may be used to treat, mitigate, and/ or overcome jet lag in an efficient manner by causing a person 105 to remain awake in an optimal manner.

[0107] In other embodiments, system 100 may be configured to wake person 101 under a variety of circumstances. [0108] In one example, if sleepwalking is suspected — for example, if a person 105 is upright, moving, and/or otherwise appears to be sleeping — wake-up stimulations may be triggered and delivered. Similarly, wake-up stimulations may be triggered and delivered if a person 105 is experiencing offensive REM patterns, for example, that may be evidenced by as excessive motion and/or screaming.

[0109] In another example, wake-up stimulations may be triggered and delivered at an optimal wake-up time based on, for example measured sleep signals and sleep stage assessments. In some embodiments, such wake-up timing may also incorporate a preset wake-up time or wake- up time range/window.

[0110] In yet another example, electronic or vibratory wake-up stimulations may be triggered and delivered as an alarm to aid persons 105 with hearing issues.

[0111] In yet another example, a remote user and/or electronic system may be permitted to trigger wake-up stimulations. This may be advantageous if, for example, person 105 is a doctor or another professional who is “on call,” or otherwise wants to ensure that they may be woken up as appropriate.

[0112] In yet another example, persons 105 with chronic diseases where certain sleeping positions and/or physiological parameters may indicate an oncoming episode of worsening condition — such as, but not limited to, COPD, cardio, or GI issues — may receive wake-up stimulations as appropriate based on time and/or analyzed sensor data to facilitate switching sleep positions and/or timely administration of medications.

[0113] Although the foregoing embodiments have been described in detail by way of illustration and example for purposes of clarity of understanding, it will be readily apparent to those of ordinary skill in the art in light of the description herein that certain changes and modifications may be made thereto without departing from the spirit or scope of the disclosure. It is also to be understood that the terminology used herein is for the purpose of describing particular aspects only, and is not intended to be limiting, since the scope of the present invention will be limited only by claims.

[0114] It is noted that, as used herein, the singular forms “a”, “an”, and “the” include plural referents unless the context clearly dictates otherwise. It is further noted that the claims may be drafted to exclude any optional element. As such, this statement is intended to serve as antecedent basis for use of such exclusive terminology as “solely,” “only,” and the like in connection with the recitation of claim elements, or use of a “negative” limitation. As will be apparent to those of ordinary skill in the art upon reading this disclosure, each of the individual aspects described and illustrated herein has discrete components and features which may be readily separated from or combined with the features of any of the other several aspects without departing from the scope or spirit of the disclosure. Any recited method can be carried out in the order of events recited or in any other order that is logically possible. Accordingly, the preceding merely provides illustrative examples. It will be appreciated that those of ordinary skill in the art will be able to devise various arrangements which, although not explicitly described or shown herein, embody the principles of the disclosure and are included within its spirit and scope.

[0115] Furthermore, all examples and conditional language recited herein are principally intended to aid the reader in understanding the principles of the invention and the concepts contributed by the inventors to furthering the art, and are to be construed without limitation to such specifically recited examples and conditions. Moreover, all statements herein reciting principles and aspects of the invention, as well as specific examples thereof, are intended to encompass both structural and functional equivalents thereof. Additionally, it is intended that such equivalents include both currently known equivalents and equivalents developed in the future, i.e., any elements developed that perform the same function, regardless of structure. The scope of the present invention, therefore, is not intended to be limited to the exemplary configurations shown and described herein.

[0116] In this specification, various preferred embodiments have been described with reference to the accompanying drawings. It will be apparent, however, that various other modifications and changes may be made thereto and additional embodiments may be implemented without departing from the broader scope of this disclosure. The specification and drawings are accordingly to be regarded in an illustrative rather than restrictive sense.

Claims

WE CLAIM:

1. A method of improving sleep quality utilizing at least one monitoring device affixed to a person, the at least one monitoring device including a first sensor, a second sensor, and a stimulation component, the method comprising: receiving, from the first sensor, first data indicative of the person’s position; receiving, from the second sensor, second data indicative of at least one of a respiratory condition of the person, a cardiac condition of the person, and a snoring condition of the person; calculating, from the first data, a position-based risk value; calculating, from the second data, at least one biometric-based risk value, the at least one biometric based risk value including at least one of a respiratory quality-based risk value, a cardiac quality-based risk value, and a snoring condition-based risk value! comparing the risk values to at least one threshold risk value to determine if at least one wake rule has been triggered; and if and only if it has been determined that at least one wake rule has been triggered, commanding the stimulation component to impart a wake stimulation.

2. The method of claim 1, wherein the step of comparing the risk values to at least one threshold value to determine if at least one wake rule has been triggered, further comprises: comparing the at least one biometric-based risk value to a threshold biometric risk value to determine if at least one wake rule has been triggered; and comparing the position-based risk value to a threshold position-based risk value to determine if at least one wake rule has been triggered.

3. The method of claim 1, wherein the step of comparing the risk values to at least one threshold value to determine if at least one wake rule have been triggered, further comprises: calculating an overall risk value by combining the position-based risk value and the at least one biometric-based risk value; and comparing the overall risk value to a threshold overall risk value to determine if at least one wake rule has been triggered.

4. The method of claim 1, wherein the step of receiving first data further comprises: receiving, from the first sensor, first data indicative of degree of supine position of the person.

5. The method of claim 4, wherein the step of calculating the position-based risk value further comprises: incorporating first data portions indicative of a degree of supine position of < 45° only if the person maintains such position for a minimum time duration, wherein the minimum time duration is at least 5 seconds.

6. The method of claim 5, wherein the step of calculating the position-based risk value further comprises: aggregating incorporated first data portions from a recent time period.

7. The method of claim 1, wherein the step of receiving second data further comprises: receiving, from the second sensor, second data indicative of at least one of respiratory airflow and respiratory pressure.

8. The method of claim 7, wherein the step of calculating the least one biometric-based risk value further comprises: calculating at least one respiratory quality-based risk value based on at least one of decrease in respiratory airflow from a respiratory airflow baseline and a decrease in respiratory pressure from a respiratory pressure baseline.

9. The method of claim 7, wherein the step of calculating the least one biometric-based risk value further comprises: calculating at least one respiratory quality-based risk value based on an increase or decrease in breaths per minute from a breaths per minute baseline.

10. The method of claim 1, wherein the step of receiving second data further comprises: receiving, from the second sensor, second data indicative of respiratory effort.

11. The method of claim 10, wherein the step of calculating the least one biometric-based risk value further comprises: calculating at least one respiratory quality-based risk value based on an increase or decrease in respiratory effort from a respiratory effort baseline.

12. The method of claim 1, wherein the step of receiving second data further comprises: receiving, from the second sensor, second data comprising at least one of recorded snoring sounds and snoring vibrations.

13. The method of claim 12, wherein the step of calculating the least one biometric-based risk value further comprises: calculating the snoring condition-based risk value based on at least one of snoring loudness, snoring duration, snoring pitch, and snoring pattern.

14. The method of claim 1, wherein the step of receiving second data further comprises: receiving, from the second sensor, second data indicative of a pulse of the person.

15. The method of claim 14, wherein the step of calculating the least one biometric-based risk value further comprises: calculating at least one cardiac quality -based risk value based on an increase or decrease in beats per minute from a beats per minute baseline.

16. The method of claim 1, further comprising: if and only if it the stimulation component has been commanded to impart the wake stimulation, imparting the wake stimulation, wherein the wake stimulation includes at least one of vibrating the at least one monitoring device, providing electrical stimulation, and providing an audible alert.

17. The method of claim 1, further comprising: if and only if it the stimulation component has been commanded to impart the wake stimulation, imparting the wake stimulation, wherein the at least one monitoring device comprises a smart phone; and the smart phone imparts the wake stimulation by vibration or audible alert.

18. A method of improving sleep quality utilizing at least one monitoring device affixed to a person, the at least one monitoring device including a first sensor, a second sensor, and a stimulation component, the method comprising: receiving, from the first sensor, first data indicative of the person’s position; receiving, from the second sensor, second data indicative of at least one of a respiratory condition of the person, a cardiac condition of the person, a snoring condition of the person, and a blood oxygen saturation condition of the person; calculating, from the first data, a position-based risk value; calculating, from the second data, at least one biometric-based risk value, the at least one biometric based risk value including at least one of a respiratory quality-based risk value, a cardiac quality-based risk value, a snoring condition-based risk value, and a blood oxygen saturation-based risk value; comparing the risk values to at least one threshold value to determine if at least one wake rule has been triggered; and if and only if it has been determined that at least one wake rule has been triggered, commanding the stimulation component to impart a wake stimulation.

19. The method of claim 18, wherein the step of receiving second data further comprises: receiving, from the second sensor, second data indicative of an Sp02 level of the person.

20. The method of claim 19, wherein the step of calculating the least one biometric-based risk value further comprises: calculating at least one blood oxygen saturation-based risk value based on a decrease in Sp02 level from a Sp02 baseline or a determination that the Sp02 levels is below a minimum Sp02 threshold.