A system and method for treating sleep disordered breathing

Abstract

A system and method for treating sleep disordered breathing is disclosed, wherein positional therapy is delivered through a flexible body contacting structure such as a mattress topper, mattress cover, or wearable device. The system comprises at least one sensor for monitoring condition data relating to the user, and at least one stimulus control arrangement for providing a stimulus to guide the user to change position during sleep. The stimulus control arrangement is responsive to a detected target condition associated with sleep disordered breathing, and may include temperature-based, audio, visual, or tactile stimulus. The system and further includes a control system configured to adaptively adjust stimulus parameters based on the user's response. Methods for monitoring user condition and delivering adaptive positional therapy are also described.

Description

A SYSTEM AND METHOD FOR TREATING SLEEP DISORDERED BREATHINGTECHNICAL FIELD

[0001] The present technology relates to one or more of the screening, diagnosis, monitoring, treatment, prevention and amelioration of sleep disordered breathing, such as snoring and / or obstructive sleep apnea. In particular, the present technology relates to using positional therapy for a patient for treating and / or preventing sleep disordered breathing, such as snoring and / or obstructive sleep apnea.BACKGROUND

[0002] The respiratory system of the body facilitates gas exchange. The nose and mouth form the entrance to the airways of a patient.

[0003] The airways include a series of branching tubes, which become narrower, shorter and more numerous as they penetrate deeper into the lung. The prime function of the lung is gas exchange, allowing oxygen to move from the inhaled air into the venous blood and carbon dioxide to move in the opposite direction. The trachea divides into right and left main bronchi, which further divide eventually into terminal bronchioles. The bronchi make up the conducting airways, and do not take part in gas exchange. Further divisions of the airways lead to the respiratory bronchioles, and eventually to the alveoli. The alveolated region of the lung is where the gas exchange takes place and is referred to as the respiratory zone. See “Respiratory Physiology” , by John B. West, Lippincott Williams & Wilkins, 9th edition published in 2012.

[0004] A range of respiratory disorders exist. Certain disorders, such as sleep disordered breathing, may be characterised by particular events, e.g. apneas, hypopneas, and hyperpneas.

[0005] Examples of respiratory disorders include Obstructive Sleep Apnea (OSA), Cheyne- Stokes Respiration (CSR), respiratory insufficiency, Obesity Hypoventilation Syndrome (OHS), Chronic Obstructive Pulmonary Disease (COPD), Neuromuscular Disease (NMD) and Chest wall disorders.

[0006] Chronic snoring is a condition affecting a considerable proportion of the population, estimated at 40% by some studies. During sleep, the patient's throat muscles relax, causing anarrowing of the pharynx. The consequence of this narrowing is an increase in the speed of the inhaled air caused by a venturi-type effect. The air excites the flexible part of the soft palate and uvula and these begin to vibrate noisily. The noise created in this way can reach up to 90 decibels.

[0007] Obstructive Sleep Apnea (OSA), a form of sleep disordered breathing is characterised by events including occlusion or obstruction of the upper air passage during sleep. It results from a combination of an abnormally small upper airway and the normal loss of muscle tone in the region of the tongue, soft palate and posterior oropharyngeal wall during sleep. The condition causes the affected patient to stop breathing for periods typically of 30 to 120 seconds in duration, sometimes 200 to 300 times per night. It often causes excessive daytime somnolence, and it may cause cardiovascular disease and brain damage. The condition is a common disorder, particularly in middle aged overweight males, although a person affected may have no awareness of the problem, e.g. see US Patent No. 4,944,310 (Sullivan).

[0008] A patient with respiratory insufficiency (a form of respiratory failure) may experience abnormal shortness of breath on exercise.

[0009] Obesity Hypoventilation Syndrome (OHS) is defined as the combination of severe obesity and awake chronic hypercapnia, in the absence of other known causes for hypoventilation. Symptoms include dyspnea, morning headache and excessive daytime sleepiness.

[0010] A range of therapies have been used to treat or ameliorate such conditions. Furthermore, otherwise healthy individuals may take advantage of such therapies to prevent respiratory disorders from arising. However, these can have a number of shortcomings.

[0011] Various therapies, such as Positive Airway Pressure (PAP) therapy (e.g., Continuous Positive Airway Pressure (CPAP) or Auto-adjusting Positive Airway Pressure (APAP)), Non- invasive ventilation (NIV), Invasive ventilation (IV), and High Flow Therapy (HFT) have been used to treat one or more of the above respiratory disorders.

[0012] Respiratory pressure therapy, such as PAP therapy, is the application of a supply of air to an entrance to the airways at a controlled target pressure that is nominally positive withrespect to atmosphere throughout the patient’s breathing cycle (in contrast to negative pressure therapies such as the tank ventilator or cuirass).

[0013] Such respiratory therapies may be provided by a respiratory therapy system or device. Such systems and devices may also be used to screen, diagnose, or monitor a condition without treating it.

[0014] PAP therapy, such as CPAP or APAP therapy, has been used to treat Sleep Apnea (such as Obstructive Sleep Apnea (OSA)). The mechanism of action is hypothesized to be that positive airway pressure acts as a pneumatic splint and may prevent upper airway occlusion, such as by pushing the soft palate and tongue forward and away from the posterior oropharyngeal wall. Treatment of OSA by PAP therapy may be voluntary, and, hence, patients may elect not to comply with therapy. For example, patients may find devices used, such as PAP masks, to provide therapy that is one or more of: uncomfortable, difficult to use, expensive and aesthetically unappealing. If a mask is uncomfortable, or difficult to use, a patient may not comply with therapy. Since it is often recommended that a patient regularly wash their PAP mask, if a mask is difficult to clean (e.g., difficult to assemble or disassemble), patients may not clean their mask and this may impact on patient compliance. Additionally, some patients do not tolerate PAP therapy well, so alternative therapies are available.

[0015] Another form of therapy system is positional therapy.

[0016] Sleep-disordered breathing, including conditions such as obstructive sleep apnea and snoring, is often influenced by the position of the user during sleep. Positional therapy is a recognized treatment approach that seeks to reduce the severity or frequency of respiratory events by encouraging or maintaining sleep positions that promote airway patency. For many individuals, sleeping in a supine position can exacerbate airway obstruction, while lateral or non-supine positions may alleviate symptoms and improve breathing quality.

[0017] Studies on large cohorts of users show a high prevalence of positional Obstructive Sleep Apnea (POSA) and exclusive POSA (ePOSA, sleep apneas only in supine position) of 75% and 36% of OSA users. Positional therapy not only can provide treatment for users with mild OSA, but may assist in other sleep-related disorders, (e.g. snoring), and for users undergoing respiratory therapy who could have a more comfortable option and / or could improve their respiratory therapy. User body position can be used for adjusting respiratory therapy.

[0018] Polysomnography (PSG) is a conventional system for diagnosis and monitoring of cardio-pulmonary disorders, and typically involves expert clinical staff to apply the system. PSG typically involves the placement of 15 to 20 contact sensors on a patient in order to record various bodily signals such as electroencephalography (EEG), electrocardiography (ECG), electrooculograpy (EOG), electromyography (EMG), etc. PSG for sleep disordered breathing has involved two nights of observation of a patient in a clinic, one night of pure diagnosis and a second night of titration of treatment parameters by a clinician. PSG is therefore expensive and inconvenient. In particular, it is unsuitable for home screening / diagnosis / monitoring of sleep disordered breathing.

[0019] Screening and diagnosis generally describe the identification of a condition from its signs and symptoms. Screening typically gives a true / false result indicating whether or not a patient’s sleep disordered breathing is severe enough to warrant further investigation, while diagnosis may result in clinically actionable information. Screening and diagnosis tend to be one-off processes, whereas monitoring the progress of a condition can continue indefinitely. Some screening / diagnosis systems are suitable only for screening / diagnosis, whereas some may also be used for monitoring.SUMMARY

[0020] In a first aspect, there is provided a sleep aid system for treating a user with sleep- disordered breathing comprising: a flexible body contacting structure that is arranged to be in contact with or in close proximity to the body of the user during a sleep session; at least one sensor for sensing first condition data relating to at least one condition of the user during the sleep session; at least one stimulus control arrangement for providing stimulus to the user; wherein the at least one stimulus control arrangement is responsive to a detected target condition of the user using the first condition data, the target condition being associated with the user’s sleep disordered breathing and the stimulus control arrangement being configured to instigate a stimulus treatment on the user for guiding the user to change position during the sleep session as therapy for the sleep disordered breathing, wherein the at least one sensor and the at least stimulus control arrangement is provided in or on the flexible body contacting structure to allow the at least one sensor and at least one stimulus control arrangement to be in contact or close proximity with the user’s body.

[0021] In some forms, the first condition data from the at least one sensor comprises position data associated with the sleeping position of the user.

[0022] In some forms, the at least one parameter of the stimulus control arrangement is caused to adaptively adjust based on the first condition data indicating a lack of response to the stimulus treatment.

[0023] In some forms, the determination of the user’s lack of response is based on monitoring changes of position of the user.

[0024] In some forms, the flexible body contacting structure is configured to be in the form of a mattress cover to be applied to a mattress such that the mattress cover is intermediate the user’s body and the mattress during the sleep session.

[0025] In some forms, the flexible body contacting structure to be arranged between a compact configuration for ease of transport and an open configuration for being arranged on the surface of the bed.

[0026] In some forms, the system further comprising memory storing machine readable instructions; and a control system including one or more processors configured to execute machine readable instructions to: receive the condition data associated with the user during a sleep session, the condition data includes the first condition data; determine if a condition of the user, based on the condition data, corresponds to the target condition; and when the user is determined to be in the target condition, cause the stimulus control arrangement to instigate a stimulus based treatment at the at least one region of the user so as to guide the user to change their sleeping position as therapy for the user’s sleep disordered breathing.

[0027] In some forms, the condition data comprises physiological data associated with the breathing of the user, and position data associated with the sleeping position of the user.

[0028] In some forms, the control system is configured to: receive condition data from the one or more sensors during the stimulus based treatment, determine, after an elapsed treatment period, if the target condition of the user persists based on the condition data, and when the target condition of the user is determined to persist, cause the stimulus control arrangement to adaptively adjust at least one parameter of the stimulus based treatment.

[0029] In some forms, the at least one parameter comprises at least one of: the intensity of stimulus, the duration of application, the location of stimulus delivery, or the timing of stimulus treatment events.

[0030] In some forms, the temperature based treatment ceases on detecting a change of the condition of the user from the target condition.

[0031] In some forms, the stimulus treatment comprises temperature-based stimulus applied to at least one region of the user.

[0032] In some forms, the stimulus control arrangement comprises at least one heating element, wherein the at least one heating element is incorporated into at least one part of the flexible structure so as to be in proximity or in contact to the user’s body for providing the temperature-based stimulus.

[0033] In some forms, the stimulus control arrangement comprises at least one cooling element wherein the at least one cooling element is incorporated into at least one part of the flexible structure so as to be in proximity or in contact to the user’s body for providing the temperature-based stimulus.

[0034] In some forms, the cooling element comprises a Peltier cell.

[0035] In some forms, the system further including wearable for being worn by the user during the sleep session wherein the wearable comprising: at least one further sensor for sensing second condition data relating to at least one condition of the user during the sleep session;

[0036] In some forms, the wearable further comprises a communication system for communicating the condition data between the wearable, and the control system.

[0037] In some forms, the wearable includes clothing. In some forms, the wearable includes a wearable device.

[0038] In some forms, the wearable comprises at least one further stimulus control arrangement wherein the further stimulus control arrangement is able to provide stimulus tothe user’s body for guiding the user to change position as part of the therapy for sleep disordered breathing.

[0039] In some forms, the wearable comprises at least one heating element for providing temperature-based stimulus. In some forms, the wearable comprises at least one cooling element for providing temperature -based stimulus.

[0040] In some forms, the one or more further sensors for sensing condition data of the user comprises one or more accelerometers for determining position condition data.

[0041] In some forms, the one or more sensors or further sensors for sensing condition data of the user comprises one or more pressure sensors.

[0042] In some forms, the one or more sensors or further sensors for sensing condition data of the user comprises one or more temperature sensors for determining a temperature of the user or the environment of the user.

[0043] In some forms, the one or more sensors or further sensors for sensing condition data of the user comprises one or more microphones.

[0044] In some forms, the one or more stimulus control arrangement comprises one or more haptic motors.

[0045] In a further aspect, there is provided method for treating a user for sleep disordered breathing, the method comprising: receiving first condition data from a flexible body contacting structure comprising at least one sensor, the flexible body contacting structure being arranged to be in contact with or close proximity to the body of the user during a sleep session, determining if a condition of the user, based on the condition data including the first condition data, corresponds to a target condition; and when it is determined that the condition of the user is in a target condition, providing stimulus to the user for guiding the user to change the position of the user as therapy for the user’s sleep disordered breathing, the stimulus being provided by a stimulus control arrangement provided on or in the flexible body contacting structure.

[0046] In some forms, the stimulus comprises temperature-based stimulus to at least one region of the user’s body.

[0047] In some forms, the stimulus includes one or more of the following: audio stimulus, tactile stimulus or visual stimulus.

[0048] In some forms, the first condition data from the at least one sensor comprises position data associated with the sleeping position of the user.

[0049] In some forms, the method further comprises adaptively adjusting at least one parameter of the stimulus control arrangement based on the first condition data indicating a lack of response to the stimulus treatment.

[0050] In some forms, determining the user’s lack of response is based on monitoring changes of position of the user.

[0051] In some forms, the method further comprises changing the stimulus by one or more of: increasing an intensity of the stimulus, increasing a length of the stimulus, and decreasing a duration between stimulus based treatment events.

[0052] In a further aspect, there is provided a mattress cover or mattress topper comprising a flexible body contacting structure when used in the system in any form described above.

[0053] In a further aspect, there is a mattress cover or mattress topper comprising a flexible body contacting structure when used in treatment method as described in any form above.

[0054] Other aspects of the present technology are related to the systems as described above which may be used in combination with systems as described in the related applications as disclosed herein. In some forms of the present technology, the sleep-aid system comprising a flexible body contacting structure in the form of a mattress topper or mattress cover as described above can be combined with the system comprising the flexible head contacting structure in the form of a pillow cover or insert, pillowcase or pillow as described in the related applications. In other forms of the present technology, additionally, or optionally, the sleep-aid system(s) comprising the head and / or body contacting structures as described above can also be used in combination with a system using temperature change to guide position change as described in the related application as mentioned herein.

[0055] The above summary is not intended to represent each implementation or every aspect of the present disclosure. Additional features and benefits of the present disclosure are apparent from the detailed description and figures set forth below.BRIEF DESCRIPTION OF THE DRAWINGS

[0056] One or more forms of the present technology will hereinafter be described with reference to the accompanying Figures, in which:

[0057] Fig. 1 is a schematic diagram showing an example system for treating a user for sleep disordered breathing according to some forms of the present technology;

[0058] Fig. 2 is a perspective view of an example apparatus for treating sleep disordered breathing in the form of a mattress cover according to some forms of the present technology;

[0059] Fig. 3 is a top view of Fig. 2;

[0060] Fig. 4 is a process flowchart for treating a user for sleep disordered breathing according to some forms of the present technology;

[0061] Fig. 5 is a another process flowchart for treating a user for sleep disordered breathing according to some forms of the present technology;

[0062] Fig. 6 is a view of wearables in the form of a wearable chest or waist strap according to some forms of the present technology for use in the system, method and apparatus of Figs 1 to 5, and

[0063] Fig. 7 is a view of the apparatus in the form of a mattress cover or insert in a compact configuration being stored in a case for portability according to some forms of the present technology.

[0064] While the present disclosure is susceptible to various modifications and alternative forms, specific implementations and embodiments thereof have been shown by way of example in the drawings and will herein be described in detail. It should be understood, however, that it is not intended to limit the present disclosure to the particular forms disclosed, but on the contrary, the present disclosure is to cover all modifications, equivalents, and alternatives falling within the spirit and scope of the present disclosure as defined by the appended claims.DETAILED DESCRIPTION

[0065] In many cases, individuals experience conditions such as snoring or sleep- disordered breathing events that are exacerbated when the user is in a certain positions compared to others, such as in a supine position.

[0066] Individuals often tend to have preferred position for sleeping. This position may be sleeping completely flat (e.g., in a horizontal position), reclined, or sitting upright; or may be on their stomach (e.g., in a prone position), on their back (in a supine position), or on their left or right side. For most people, their body position will change many times during a sleep session. For example, an individual will normally arouse briefly from sleep and change positions before entering sleep again in the new position. For young adults, this shifting of position during sleep may happen in the order of four to five shifts per hour. As humans age, the number of shifts in sleep position per sleep session tends to reduce, such that elderly people more commonly might only shift sleeping positions twice per hour on average. In addition, younger adults and children are expected to experience similar durations in the various trunk positions, whereas more elderly people tend to spend less time in the prone position and more time supine.

[0067] Breathing conditions for an individual’s body are different when the individual is lying down as compared to when the individual is standing up. When the individual is sitting or is on the feet, the individual’s airway is pointing downward, leaving breathing and airflow relatively unrestricted. However, when the individual settles down to sleep, the individual’s body is imposed to breathing in a substantially horizontal position, meaning that gravity is now working against the airway. Sleep apnea and snoring can occur when the muscular tissues in the top airway relax and the individual’s lungs get limited air to breathe via the nose or throat. While the process of breathing is the same at night, the individual’s surrounding tissues can vibrate, causing the individual to snore. Even relaxed muscles can cause sleep apnea because the total blockage of the airway hampers breathing fully, forcing the individual to wake up in the middle of sleep. As a result, there are advantages afforded to the individual for sleeping in positions that best support the individual’s breathing patterns. For example, some individual may benefit from sleeping in a reclined position rather than completely horizontal relative to ground.

[0068] Sleeping in the supine position can often be problematic for those who have snoring problems, breathing problems, or sleep apnea. This happens because the gravitational force enhances the capacity of the jaw, the tongue, and soft palate to drop back toward the throat. It narrows the airways and can cause increased resistance to airflow while breathing.

[0069] Sleeping in the prone position may seem like an alternative to the gravity issue as the downward force pulls the tongue and palate forward. While this is true to an extent, when sleeping in this position, the individual’s nose and mouth can become blocked by the pillow. It may affect the individual’s breathing. Apart from this, it may also cause neck pain, cervical problems, or digestion problems, which in turn affect the individual’s sleep quality.

[0070] Some studies suggest that sleeping on the side may be the most ideal position for snoring and sleep apnea sufferers. Because when the individual’ s body is positioned on its side during rest, the airways are more stable and less likely to collapse or restrict air. In this position, the individual’s body, head and torso are positioned on one side (left or right), arms are under the body or a bit forward or extended, and legs are packed with one under the other or slightly staggered. While both lateral (left and right) sides are considered as good sleeping positions, for some the left lateral position may not be an ideal one. That’s because while sleeping on the left side, the internal organs of the body in the thorax can face some movement. And the lungs may add more weight or pressure on the heart. This can affect the heart’s function, and it can retaliate by activating the kidneys, causing an increased need for urination at night. The right side, however, puts less pressure on the vital organs, such as lungs and heart. Sleeping on a particular side can also be ideal if a joint (often shoulder or hip) on the individual’s other side is causing pain.

[0071] When an individual has sleep apnea or other breathing disorders, getting a good and peaceful sleep becomes difficult. However, being in the right sleeping position can help the user get comfortable and at the same time help overcome the breathing problems that the individual usually face while sleeping. Positional therapy not only can provide treatment for users with mild OSA or snoring , but also for users already undergoing another therapy who could have a more comfortable option (e.g., lower pressure in Positive Airway Pressure (PAP) machine, smaller displacement in mandibular repositioning devices, etc.).

[0072] In some forms of the technology, a system and method is provided that monitors the condition of a user while sleeping — such as snoring, respiratory events, and / or body position — using one or more sensors. When a condition is identified that is likely to benefit from positional therapy, for example, snoring while the user is supine, the system initiates a control process to provide a stimulus at one or more specific areas of the user’s body. This stimulus may be temperature control, which may involve localized heating or cooling, is applied with the aim of prompting the user to change position and thereby alleviate the detected condition. The system may further incorporate an adaptive operation, wherein the response of the user is monitored by sensors after the stimulus control process has been in effect for a period of time. If the monitored data indicate that the desired positional change or improvement in the user’s condition has not occurred, the system can adjust the stimulus control parameters — such as intensity, duration, or location — until the user’s position or respiratory state improves. In this way, the system may provide a closed-loop, user-specific positional therapy system that selectively applies stimulus control only when beneficial, and adaptively optimizes the control process based on the user’s actual response.

[0073] A system and method for treating sleep disordered breathing, wherein positional therapy is delivered through adaptive temperature regulation, is disclosed in co-pending international application filed 29 October 2025 entitled A SYSTEM and METHOD FOR TREATING SLEEP DISORDERED BREATHING and claiming common priority to the present application. The contents of that application are herein incorporated by cross reference.

[0074] The various modules and components of the system of the adaptive positional therapy system may be implemented in a range of physical forms, including mattress covers, pillow inserts, wearable straps, ear buds or other user-contacting devices. The sensors and temperature control elements may be distributed across multiple devices or integrated into a single apparatus, depending on the application and user needs. The system may also be configured for wireless communication with external devices for data logging, remote monitoring, or integration with other therapeutic systems.

[0075] The incorporation of positional therapy components into particular form factors for practical use in a home environment can significantly enhance the useability of the system. In one such aspect, integrating sensors and stimulus actuators within flexible, portable components such as mattress toppers can enables effective monitoring and therapeuticintervention without the need for complex or intrusive equipment. This design allows users to benefit from advanced positional therapy in the comfort of their own home, facilitating regular use and improving compliance with recommended treatment protocols. The ease of application and removal, combined with compatibility with standard bedding, ensures that the device can be seamlessly integrated into existing sleep routines. Furthermore, the portability of the such form factors enable users to maintain continuity of therapy when traveling or sleeping away from home, thereby supporting consistent management of sleep-disordered breathing and related conditions.

[0076] Referring now to Figs 1 to 7, there is described a sleep-aid system 10, methods 100, 200 and apparatus 2 for treating a user for sleep disordered breathing during a sleep session according to some forms of the present technology. The system 10, method 100, 200 and apparatus 2 comprise a flexible body contacting structure 2 which is arranged to be in contact with or in close proximity to the body of a user during the sleep session. The system 10 also comprises one or more sensors 8 configured to generate condition data associated with a condition of the user.

[0077] Fig 1 shows a schematic diagram of a sleep-aid system 10 for treating a user for a sleep - related respiratory disorder during the sleep session according to a form of the present technology. The system 10 may be used treating a sleep disordered breathing by use of a sensing system 11 which comprises the one or more sensors 8 configured to generate condition data associated with a condition of the user (not shown) and generate a condition signal based on the condition data. The flexible body contacting structure 2 can comprise material configured to be flexible and conform to the user’s body such as a woven material or flexible polymer matrix which can be used to cover at least part of a bed as illustrated in Figs 2 and 3.

[0078] The at least one sensor 8 can be in incorporated onto the surface or integrated into the flexible body contacting structure 2 as long as the sensors 8 are still able to easily generate the condition data by having sufficient proximity or contact to the user’ s body which will allow the sensors to gather condition data. It is envisaged that the flexible body contacting structure 2 could preferably comprise a plurality of sensors 8 which would be able to generate multiple condition signals and thereby provide condition data on the different regions of the user’s body, even if the user is wearing thick clothing. Preferably, the plurality of sensors 8 would be arranged at equidistantly spaced apart positions, such as a grid structure, throughout the flexiblebody contacting structure 2. In alternative embodiments, the plurality of sensors 8 could be arranged more densely around particular area to capture condition data at certain regions of the user’s body. For instance, the plurality of sensors 8 could be more densely spaced about the torso, and / or less densely spaced around the feet or legs.

[0079] In preferred forms of the present technology, the flexible body contacting structure 2 is in the form of a mattress topper i.e. a padded section which is typically known to be added to a top surface of a mattress for providing additional padding and comfort. In other preferred forms of the present technology, the flexible body contacting structure is in the form of a mattress cover.

[0080] The system 10 also comprises a stimulus control arrangement 13 comprising at least one stimulus control element 9 for providing stimulus to the user as illustrated in Figs 2 and 3. It is envisaged that the flexible body contacting structure 2 could preferably comprise a plurality of stimulus control elements 9 which would be able to provide stimulus to the different regions of the user’s body, whether simultaneously or at different times. Preferably, the plurality of stimulus control elements 9 would be arranged at equidistantly spaced apart positions, such as a grid structure, throughout the flexible body contacting structure 2. In alternative embodiments, the plurality of stimulus control elements 9 could be arranged more densely around particular areas to provide stimulus at certain regions of the user’s body. For instance, the plurality of stimulus control elements 9 could be more densely spaced about the torso, and / or less densely spaced around the feet or legs.

[0081] The at least one sensor 8 and the at least one stimulus control element 9 is responsive to the condition data for guiding the user to change position during the sleep session, wherein the at least one sensor and at least one stimulus control element 9 is provided in or on the flexible body contacting structure 2 to allow the at least one sensor and at least one stimulus control element to be in contact or close proximity with the user’s body.

[0082] The flexibility of the flexible body contacting structure 2 allows the sleep-aid system or apparatus to be easily conform to the user’s body which allows more condition data to be more accurately generated if there are a plurality of sensors. Additionally, the flexibility of the body contacting structure 2 allows arrangement of the system 10 from a compact configuration which provides ease of transport or storage, and an open configuration where thebody contacting structure is able to be applied to the top of a mattress before the sleep session. Preferably the compact arrangement is a rolled or folded configuration as illustrated in Fig. 9, and can be stored in a container or case 30. Thus the user can easily take the sleep-aid system 10 with them when travelling and which reduces sleep disruption when away from home.

[0083] The system 10 can further comprise a processing system 12 in communication with the stimulus control arrangement 13 comprising the at least one stimulus control element 9 and the sensing system 11. According to a form of the present technology, the processing system 12 can further be configured to monitor the condition signal. The processing system 12 is configured to determine if a condition of the user, based on the condition data, corresponds to at least one pre-determined target condition; and when the user is determined to be in the at least one target condition, communicate a control signal to the stimulus control arrangement and the control signal configured to cause the stimulus control arrangement to provide stimulus to guide the user to change their position from the target condition.

[0084] Referring now to Fig 2, there is described an apparatus 2 for treating a user for a sleep-related respiratory disorder according to some forms of the present technology. The apparatus 2 comprises one or more sensors 8 configured to generate condition data associated with the condition of the user.

[0085] The condition data of the user can relate to any information or data that relates to the user, including respiratory information, sleep state information, i.e. is the user asleep and if so, the stage of sleep, heart rate or other physiological information of the user, including blood oxygen content, eye movements, temperature of the user, and any regions of their body. The data may also include information relating to the user’s environment such as temperature of the sleep environment, bedding, bed or pillow type, humidity of the air and ambient light. The respiratory information can include the rate of respiration, shallow or deep breathing, snoring magnitude and frequency, and apnoea event frequency.

[0086] The condition of the user includes the position of the user, when sleeping, for instance whether the user is on their back or side positions or in a prone position. In the system and method described, if one of the conditions identified from the condition data is that the position of the user is in a predetermined target position then stimulus is provided to the user to the user to guide them to change position from that predetermined target position.

[0087] To assist in guiding the user from a target condition or position to a non-target condition, i.e. snoring to non-snoring, supine to side position, prone to side position, the system 10 can also provide stimulus to the user by means of the stimulus control arrangement 13. The stimulus could include but not limited to audio-based stimulus, including alerts, music or speech, light-based stimulus, such as strobing, flashing or constant light, or tactile stimulus. The tactile stimulus can be delivered by haptic motors, while the audio stimulus can be delivered by speakers, or lights. The light-based stimulus can be delivered by LEDs or display screens. The audio, haptic or light-based stimulus can be delivered by speakers, displays or haptic motors which can be incorporated into the mattress topper or mattress cover 2 as illustrated in Fig. 2. Alternatively, the system 10 can include wearables 14 comprising an associated smart portable device, smart ring, headphones, clothing, face or eye mask or earbuds which is in communication with the processing system 12, stimulus control arrangement 13 and sensing system 11. The wearables 14 can comprise stimulus control elements 9 to provide stimulus as described above, and / or one or more sensors 8 for monitoring condition data as illustrated in Fig. 6.

[0088] In a preferred form of the present technology, the stimulus may also include stimulus delivered by inflatable portions in the mattress topper or mattress cover 2. By inflating or deflating the inflatable portions, the system 10 can also deliver more effective changes in the user by forcibly moving them from a target condition to a non-target condition. For instance, inflatable portions can be inflated to raise one side of the user to assist in moving them from a supine position to a side position, or even from one side position to another side position.

[0089] The stimulus can comprise temperature-based stimulus wherein the temperaturebased stimulus includes changing the temperature of the at least one region of the user so as to guide the user to change their position from the target condition. Heating or cooling regions of a user to guide them into a non-target condition may be considered advantageous by delivering stimulus to the user without being disruptive thereby assisting the user to change positions without altering their sleep state substantively. Furthermore, users may not respond to audio, visual or haptic stimulus, especially in some deep phrases of sleep, and therefore may be more responsive to temperature-based stimulus due to autonomic responses of the body.

[0090] The system 10 and apparatus 2 may also be configured to adaptively delivering stimulus by changing the stimulus until the user changes to the one or more non-target positions. In an example, the stimulus can include adaptively adding one or more nontemperature-based stimulus in addition to or substituted with the temperature-based stimulus. The system can also adaptively deliver stimulus (whether temperature or non-temperature based) by increasing the magnitude of the stimulus, increasing a length of the application of the stimulus, and decreasing a duration between stimulus events.

[0091] The temperature -based stimulus can be delivered by an environment conditioning system or environment conditioning apparatus configured to apply heating and / or cooling to at least one region of the user. As illustrated in Figs. 2 and 3, the environment conditioning device or apparatus 2 can be integrated into the flexible body contacting structure 2 in the form of a mattress topper or a mattress cover 2 configured to overlay a portion of the mattress for receiving the body of the user. The mattress cover or topper 2 could be sized for a single person on a double bed, to accommodate two people on a double bed or sized for a single bed.

[0092] The system 10 can include wearables 14 in the form of a head, chest or waist mounted strap as illustrated in Fig. 6 where the wearables 14 are external to the part of the bed such as the mattress topper or mattress cover 20. In alternative arrangements, the wearables 14 can be in the form of head, chest or waist wrap, that is able to wrap about the chest or waist of the user, the wrap can have portions which are configured to heat or cool one or more regions of the user, or other stimulus control arrangements which can provide stimulus in the form of audio, haptic or light-based stimulus.

[0093] It is envisaged that wearables 14 could be in other forms, such as eye masks, blanket or doona, ear buds or clothing such as pyjamas, or other devices and apparatus that are normally used with the user in a sleep environment. A mattress cover 2 or mattress topper 2 is considered more desirable due to its portability especially for users who have active lifestyles and may sleep in different locations or travel for work or leisure. Therefore in a preferred embodiment, the apparatus 2 is in the form of a flexible mattress topper or mattress cover which can be rolled or otherwise configured into a compact form for easy storage and transport as shown in Fig. 7.

[0094] The system 10 or apparatus 2 can have heating elements (not shown), for example conductive wires which can transmit a current thereby heating one or more portions of the cover which can then heat one or more regions of the user. The system 10 or apparatus 2 could have cooling elements, such as Peltier cells which can cool one or more regions of the user. The heating or cooling elements are insulated from the user to protect the user against risk of injury.

[0095] In some embodiments, the system 10 or apparatus 2 will have the capability of applying both heating and cooling to one or more regions simultaneously to provide more effective stimulus to the user. The regions of the user can include at least part of the torso, at least part of the legs, at least part of the arms, the neck, the head. Temperature-based stimulus may also be applied is to a front, a rear and a side of the following: the torso, at least one leg, at least one arm and head. However, it would be understood that the person skilled in the art would be able to apply the temperature-based stimulus to other regions of the user not explicated stated in this disclosure.

[0096] For example, one side 26 or the opposite side of the cover 28 (to one side of axis A indicated on Fig. 2) could be heated or cooled to cause the user to turn from a supine position to a side position. In another embodiment, one side could be heated, and the other could be cooled to effect more effective guidance of the user into a non-target condition.

[0097] Alternatively, portions of the cover 2 near the feet may be heated or cooled to guide the user to a change in position, i.e. the user may curl into a foetal position, and therefore a side-sleeping position to avoid the cooled or heated bottom portions. It can be understood that the principles applied to the cover 20 in this embodiment could also be applied to a mattress topper.

[0098] Depending on the preference of the user, or even the external environment, the user may wish to avoid the heated portions of the cover 2 or would be drawn to the heated portions and thereby is guided to a non-targeted position from a targeted position. Similarly, the user may wish to avoid the cooled portions of the cover 2 or would be drawn to the cooled portions and thereby is guided to a non-targeted position from a targeted position. For example, if the weather is cold, the user may wish to change position to move closer to a heated portion of the cover 2, or if the weather is hot, the user may wish to change position away from the heatedportion. Similarly, if the weather is hot, the user may wish to change position to move closer to a cooled portion of the cover 2, or if the weather is hot, the user may wish to change position away from the cooled portion.

[0099] Fig 4 shows a method 100 implemented by the sleep-aid system 10 for treating a user for a sleep-related respiratory disorder during a sleep session, according to an embodiment of the present technology.

[0100] First at step S 101, the flexible body contacting structure in a form of a mattress cover or topper 2 is applied to the top surface of a mattress as illustrated in Figs 2 and 3. The portability of the body contacting structure is advantageous if the user is away from home at a hotel or other remote location and wishes to conduct a sleep session away from home. The user can then trigger the start of the sleep session at step S102. This can be triggered by a signal generated by the processing module, which could be triggered automatically when the presence of the user is determined by the mattress topper or mattress cover 2 for example by the activation of pressure sensors and the like. Alternatively, the start of the sleep session can be triggered manually by a user that they are ready to sleep.

[0101] At step S 103, the sensing system 11 collects condition data from the user, from the sensors 8 which are embedded throughout the mattress topper or mattress cover 2, including temperature, movement, respiration or other condition data. The sensing system 11 generates a condition signal based on the condition data.

[0102] At S104, the sleep-aid system 10 monitors the condition data.

[0103] At step S105, if the system 10 determines a response depending on a condition of the user, then at step S106, the system 10 can cause the stimulus control arrangement 13 to provide stimulus to guide the user to change their position, for example to a side sleeping position, from a back sleeping position. If not, the processing system 12 continues to monitor the condition data and returns to step S104.

[0104] At step S107, the sleep session ends. This can be triggered by a signal generated by the system 10, which could be triggered automatically when the absence of the user is determined by the mattress topper or mattress cover 2 for example by the de-activation ofpressure sensors and the like. Alternatively, the end of the sleep session can be triggered manually by a user to indicate that they are awake.

[0105] Fig 5 shows another method 200 implemented by the processing module representing the processing system 12 for treating a user for a sleep - related respiratory disorder during a sleep session, according to a form of the present technology.

[0106] First at step S201, the start of the sleep session by a user is triggered. This can be triggered by a signal generated by the processing module, which could be triggered automatically when the presence of the user is determined by the mattress topper or mattress cover 2 for example by the activation of pressure sensors and the like. Alternatively, the start of the sleep session can be triggered manually by a user that they are ready to sleep.

[0107] At step S202, the sensing system 11 collects condition data from the user, from the sensors 8 which are embedded throughout the mattress topper or mattress cover 2, including temperature, movement, respiration or other condition data. The sensing system 11 generates a condition signal based on the condition data.

[0108] At S203, the processing system 12, in communication with the sensing system 11, monitors the condition data.

[0109] At step S204, if the processing system 12 determines a condition of the user, and if the user corresponds to at least one pre-determined target condition. In this example, the user may be sleeping on their back, which can be set as the pre-determined target condition. If the user is sleeping in the predetermined target condition (i.e. on their backs), the processing system 12, communicates a control signal to the stimulus control arrangement 13 and the control signal configured to cause the stimulus control arrangement 13 to provide stimulus to guide the user to change their position, for example to a side sleeping position, from the predetermined target condition. If not, the processing system 12 continues to monitor the condition data and returns to step S202.

[0110] At step S205, if it is determined that the user is still in the predetermined target condition, then the processing system 12 is configured to continue the stimulus based treatment, and may even adaptively change the stimulus signal to the stimulus control arrangement 13 at step S206 so as to change the type, frequency, intensity of the stimulus until it is determinedthat the user is no longer in the predetermined target condition. At which point, the processing system 12 continues to monitor the condition data and returns to step S202.

[0111] At step S207, the sleep session ends. This can be triggered by a signal generated by the processing module, which could be triggered automatically when the absence of the user is determined by the mattress topper or mattress cover 20 for example by the de-activation of pressure sensors and the like. Alternatively, the end of the sleep session can be triggered manually by a user that they are awake.

[0112] The temperature-based stimulus or other stimulus can be controlled by the processing system 12 having memory storing machine readable instructions; including one or more processors configured to execute machine readable instructions to: receive the condition data associated with the user during a sleep session; and then determine if a condition of the user, based on the condition data, corresponds to at least one pre-determined target condition; and provide the stimulus on that basis.

[0113] The system 10 and method 100, 200 can also include receiving body temperature information from the condition data of the user, and wherein the application of the temperature change includes heating or cooling a predetermined number of degrees above or below a measured body temperature of the user or the user’s environment. Therefore, a number of temperature sensors 8 can be used to monitor the temperature of the user, preferably at different regions of the user, and then apply the heating and / or cooling at the different regions. The sensors 8 for receiving information on the condition of the user or user’s environment of the user can include temperature sensors, pressure sensors, audio and light collecting sensors, position sensors such as accelerometers, gyroscopes or cameras, heart rate monitors, microphones, respiratory sensors and oximeters. The sensors can be located within different regions of the system 10 or apparatus 2 for monitoring of the temperature of the user and / or the region, and / or the portion of the device or apparatus 2. It is also expected that sensor information from other devices such as wearables, including smart watches, smart rings, smart devices including tablets or phones could also be used. In other embodiments, if the user is also using a CPAP machine, sensor information from the CPAP machine and system could also be used in the system 10, method 100 or apparatus 2 of this disclosure.

[0114] It is also expected that the mattress topper or mattress cover of the system 10 and apparatus 2 described herein can also be used in combination with the pillow or pillow cover comprising a flexible head contacting structure as described in in co-pending international application filed 29 October 2025 entitled A SYSTEM AND METHOD FOR TREATING SLEEP DISORDERED BREATHING and claiming common priority to the present application. The contents of that application are herein incorporated by cross reference. In this way, both the systems comprising a flexible head-contacting structure and a flexible bodycontacting structure can form a more complete sleep-aid system which can address the sleep- related respiratory disorders more effectively. Additionally, or optionally, the system(s) comprising the head and / or body contacting structures can also be used in combination with a system using temperature change to guide position change as described in the related application as mentioned in paragraph

[0074] .

[0115] The system 10, method 100, 200 and apparatus 2 may also be configured to provide information to the user or a therapist on the efficacy of the system, method and apparatus, and in particular the efficacy of the stimulus. The information of the efficacy of the system, method or apparatus can be based on monitoring the condition of the user as described above over a period of time to obtain condition data. The specific condition data can include, for example respiratory information including the Apnoea- Hypopnea Index (AHI), sleep state, total sleep time, reduced daytime sleepiness, increased daytime activity, sleep environment, and other physiological information of the user. By understanding if the user’s condition improves or degrades over a period of time and correlating that with the treatment being provided to the user, a customised or personalised treatment can be developed for the user. In addition, there can be a deeper understanding of how one type of stimulus may be more or less effective i.e. for example whether cooling or heating is better for assisting the user to move from a target position to the non-targeted position, the treatment including the type, frequency and intensity of stimulus can be tailored to the user.

[0116] In the claims which follow and in the preceding description of the invention, except where the context requires otherwise due to express language or necessary implication, the word “comprise” or variations such as “comprises” or “comprising” is used in an inclusive sense, i.e. to specify the presence of the stated features but not to preclude the presence or addition of further features in various embodiments of the invention.

Claims

CLAIMS:

1. A sleep aid system for treating a user with sleep- disordered breathing comprising: a flexible body contacting structure that is arranged to be in contact with or in close proximity to the body of the user during a sleep session; at least one sensor for sensing first condition data relating to at least one condition of the user during the sleep session; at least one stimulus control arrangement for providing stimulus to the user; wherein the at least one stimulus control arrangement is responsive to a detected target condition of the user using the first condition data, the target condition being associated with the user’s sleep disordered breathing and the stimulus control arrangement being configured to instigate a stimulus treatment on the user for guiding the user to change position during the sleep session as therapy for the sleep disordered breathing, wherein the at least one sensor and the at least stimulus control arrangement is provided in or on the flexible body contacting structure to allow the at least one sensor and at least one stimulus control arrangement to be in contact or close proximity with the user’s body.

2. The system according to claim 1, wherein the first condition data from the at least one sensor comprises position data associated with the sleeping position of the user.3 The system according to claim 1 or 2, wherein at least one parameter of the stimulus control arrangement is caused to adaptively adjust based on the first condition data indicating a lack of response to the stimulus treatment.

4. The system according to claim 3, wherein the determination of the user’s lack of response is based on monitoring changes of position of the user.

5. The system of any preceding claim, wherein the flexible body contacting structure is configured to be in the form of a mattress cover to be applied to a mattress such that the mattress cover is intermediate the user’s body and the mattress during the sleep session.

6. The system of claim 4, wherein the flexible body contacting structure to be arranged between a compact configuration for ease of transport and an open configuration for being arranged on the surface of the bed.

7. The system of any one of the preceding claims, further comprising memory storing machine readable instructions; and a control system including one or more processors configured to execute machine readable instructions to: receive the condition data associated with the user during a sleep session, the condition data includes the first condition data; determine if a condition of the user, based on the condition data, corresponds to the target condition; and when the user is determined to be in the target condition, cause the stimulus control arrangement to instigate a stimulus based treatment at the at least one region of the user so as to guide the user to change their sleeping position as therapy for the user’s sleep disordered breathing.

8. A system according to claim 7, wherein the condition data comprises physiological data associated with the breathing of the user, and position data associated with the sleeping position of the user.

9. The system according to either claim 7 or 8, wherein the control system is configured to: receive condition data from the one or more sensors during the stimulus based treatment, determine, after an elapsed treatment period, if the target condition of the user persists based on the condition data, and when the target condition of the user is determined to persist, cause the stimulus control arrangement to adaptively adjust at least one parameter of the stimulus based treatment.

10. The system of claim 9, wherein the at least one parameter comprises at least one of: the intensity of stimulus, the duration of application, the location of stimulus delivery, or the timing of stimulus treatment events.

11. The system according to any preceding claim, wherein the temperature based treatment ceases on detecting a change of the condition of the user from the target condition.

12. The system of any one of the preceding claims, wherein the stimulus treatment comprises temperature-based stimulus applied to at least one region of the user.

13. The system of claim 12, wherein the stimulus control arrangement comprises at least one heating element, wherein the at least one heating element is incorporated into at least one part of the flexible structure so as to be in proximity or in contact to the user’s body for providing the temperature-based stimulus.

14. The system of any one of claim 12 or claim 13, wherein the stimulus control arrangement comprises at least one cooling element wherein the at least one cooling element is incorporated into at least one part of the flexible structure so as to be in proximity or in contact to the user’s body for providing the temperature-based stimulus.

15. The system of claim 9, wherein the cooling element comprises a Peltier cell.

16. The system of any one of the preceding claims, further including wearable for being worn by the user during the sleep session wherein the wearable comprising: at least one further sensor for sensing second condition data relating to at least one condition of the user during the sleep session.

17. The system of claim 16, when dependent on claim 7, wherein the wearable further comprises a communication system for communicating the condition data between the wearable, and the control system.

18. The system of claim 16 or 17, wherein the wearable includes clothing.

19. The system of any one of claims 16 to 18, wherein the wearable includes a wearable device.

20. The system of any one of claims 16 to 19, wherein the wearable comprises at least one further stimulus control arrangement wherein the further stimulus control arrangement is able to provide stimulus to the user’s body for guiding the user to change position as part of the therapy for sleep disordered breathing.

21. The system according to any one of claims 16 to 20, wherein the wearable comprises at least one heating element for providing temperature-based stimulus.

22. The system according to any one of claims 11 to 15, wherein the wearable comprises at least one cooling element for providing temperature-based stimulus.

23. The system according to any one of claims 16 to 22, wherein the one or more further sensors for sensing condition data of the user comprises one or more accelerometers for determining position condition data.

24. The system according to any one of the preceding claims, wherein the one or more sensors or further sensors for sensing condition data of the user comprises one or more pressure sensors.

25. The system according to any one of the preceding claims, wherein the one or more sensors or further sensors for sensing condition data of the user comprises one or more temperature sensors for determining a temperature of the user or the environment of the user.

26. The system according to any one of the preceding claims, wherein the one or more sensors or further sensors for sensing condition data of the user comprises one or more microphones.

27. The system according to any one of the preceding claims, wherein the one or more stimulus control arrangements comprises one or more haptic motors.

28. A method for treating a user for sleep disordered breathing, the method comprising: receiving first condition data from a flexible body contacting structure comprising atleast one sensor, the flexible body contacting structure being arranged to be in contact with or close proximity to the body of the user during a sleep session, determining if a condition of the user, based on the condition data including the first condition data, corresponds to a target condition; and when it is determined that the condition of the user is in a target condition, providing stimulus to the user for guiding the user to change the position of the user as therapy for the user’s sleep disordered breathing, the stimulus being provided by a stimulus control arrangement provided on or in the flexible body contacting structure.

29. The method of claim 28, wherein the stimulus comprises temperature-based stimulus to at least one region of the user’s body.

30. The method of either claim 28 or 29, wherein the stimulus includes one or more of the following: audio stimulus, tactile stimulus or visual stimulus.

31. The method according to any one of claims 28 to 30, wherein the first condition data from the at least one sensor comprises position data associated with the sleeping position of the user.

32. The method according to any one of claims 28 to 31, comprising adaptively adjusting at least one parameter of the stimulus control arrangement based on the first condition data indicating a lack of response to the stimulus treatment.

33. The method according to claim 32, comprising determining the user’s lack of response based on monitoring changes of position of the user.

34. The method of any either claim 32 or 33, comprising changing the stimulus by one or more of: increasing an intensity of the stimulus, increasing a length of the stimulus, and decreasing a duration between stimulus based treatment events.

35. A mattress cover or mattress topper comprising a flexible body contacting structure when used in the system of any one of claims 1 to 27.

36. A mattress cover or mattress topper comprising a flexible body contacting structure when used in the method of any one of claims 28 to 35.

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