A system and method for treating sleep disordered breathing

Abstract

A system and method for treating sleep disordered breathing, wherein positional therapy is delivered through adaptive temperature regulation. The system includes one or more sensors configured to monitor user conditions such as body position, respiratory activity, and sleep quality. Upon detection of a target condition—such as snoring or sleep-disordered breathing in a supine position—the system initiates a control process to apply localised heating and / or cooling to specific regions of the user's body The system may operate in a closed-loop manner, receiving feedback from the sensors to determine the effectiveness of the treatment and adaptively adjusting temperature parameters such as intensity, duration, and location.

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 a narrowing of the pharynx. The consequence of this narrowing is an increase in the speed of theinhaled 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 with respect 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] The present technology provides systems and methods for delivering positional therapy that may utilise temperature regulation to prompt beneficial changes in user position and thereby support management of sleep disordered breathing.

[0021] In a first aspect, there is provided a system for treating a user with sleep disordered breathing, comprising; one or more sensors configured to generate condition data associated with a condition of the user; a temperature control arrangement configured to apply heating and / or cooling to at least one region of the user; memory storing machine readable instructions; anda 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; determine if a condition of the user, based on the condition data, corresponds to at least one target condition associated with the user’s sleep disordered breathing; and when the user is determined to be in the at least one target condition, cause the temperature control arrangementto instigate a temperature 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.

[0022] 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.

[0023] In some forms, the control system is configured to: receive condition data from the one or more sensors during the temperature 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 temperature control arrangement to adaptively adjust at least one parameter of the temperature based treatment.

[0024] In some forms, the at least one parameter comprises at least one of: the intensity of heating or cooling, the duration of application, the location of temperature delivery, or the timing of temperature control events.

[0025] In a further aspect, there is provided a system for treating a user with sleep disordered breathing, comprising; one or more sensors configured to generate condition data associated with a condition of the user, the condition data comprises physiological data associated with the breathing of the user, and position data associated with the sleeping position of the user; a temperature control arrangement configured to apply heating and / or cooling to at least one region of the user; 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, determine if a condition of the user, based on the condition data, corresponds to at least one target condition associated with the user’ s sleep disordered breathing, the target condition including the position of the user; and when the user is determined to be in the at least one target condition, cause the temperature control arrangement to instigate a temperature 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; and adjust at least one parameter of the temperature based treatment if the position of the user remains unchanged after an elapsed time period.

[0026] In some forms, the at least one parameter comprises at least one of: the intensity of heating or cooling, the duration of application, the location of temperature delivery, or the timing of temperature control events.

[0027] In some forms, the control system is configured to cause the temperature control arrangement to alternate between heating and cooling, or to apply heating and / or cooling to different regions of the user’s body, in response to the user’s lack of response to a temperature based treatment in a previous period.

[0028] In some forms, the control system is configured to cause the temperature control arrangement to alternate the intensity of heating and / or cooling in response to the user’s lack of response to a temperature based treatment in a previous period.

[0029] In some forms, the determination of the user’s lack of response is based on monitoring changes of position of the user.

[0030] In some forms, the determination of the user’s lack of response is based on changes of physiological data associated with the breathing of the user.

[0031] In some forms, the temperature based treatment ceases on detecting a change of the condition of the user from the target condition.

[0032] In some forms, the control system is configured to receive sleep data measuring one or more physiological parameters of the user correlated with sleep quality.

[0033] In some forms, the control system utilises the sleep data to determine if a condition of the user corresponds to at least one target condition and / or a parameter of the temperature based treatment at the at least one region of the user under the temperature control arrangement.

[0034] In some forms, the control system is configured to receive temperature data from one or more sensors configured to measure the body temperature of the user.

[0035] In some forms, a characteristic of the regulation of the temperature at the at least one region of the user includes heating or cooling a predetermined amount above or below the measured body temperature of the user.

[0036] In some forms, the control system is further configured to receive environmental data from one or more sensors configured to measure at least one of light exposure, temperature, or humidity in the user’s environment.

[0037] In some forms, a parameter of the temperature based treatment at the at least one region of the user is dependent on a measured characteristic of the environmental data.

[0038] In some forms, the target condition is associated with one or more of: a condition relating to the position of the user; a condition relating to the respiration of the user; a condition relating to interruptions in sleep of the user; a condition relating to snoring of the user; a condition relating to snoring magnitude of the user; or a condition relating to snoring frequency of the user.

[0039] In some forms, the control system is configured to terminate or reduce the temperature event if sensor data indicates that the user’s sleep quality or physiological state is adversely affected by the event.

[0040] In some forms, the control system is configured to store historical sensor data and user responses temperature based treatment to adaptively refine future temperature based treatments for the user.

[0041] In a further aspect, a method for treating a user for sleep disordered breathing, the method comprising: receiving condition information from at least one sensor configured to sense condition information relating to at least one condition of the user; determining if a condition of the user during a sleep session, based on the condition information, corresponds to at least one target condition associated with the user’s sleep disordered breathing; and when it is determined that the condition of the user is in one of the at least one target condition, providing a temperature based event to the user for guiding the user to change sleeping position as therapy for the user’s sleep disordered breathing.

[0042] In some forms, the method further comprises applying heating or cooling to at least one region of the user’ s body in response to the determination that the user is in the target condition.

[0043] In some forms, the method further comprises receiving body temperature information from at least one sensor, and wherein the application of the temperature change includesheating or cooling a predetermined amount above or below a measured body temperature of the user.

[0044] In some forms, the method further comprising: receiving environmental temperature information and wherein the application of the temperature change depends on the ambient temperature of the user’s environment.

[0045] In some forms, the temperature-based treatment is applied by a system having a plurality of heating or cooling elements, and wherein the elements are selectively activated to target specific regions of the user’s body.

[0046] In some forms, the method further comprising: monitoring the user’s position and / or respiratory condition after the application of the temperature-based treatment for an elapsed period, and adaptively adjusting at least one parameter of the temperature-based treatment based on feedback received from the at least one sensor that the target condition persists.

[0047] In some forms, adaptively adjusting the temperature -based treatment comprises at least one of: increasing the intensity of heating or cooling, increasing a length of the application, decreasing a duration between treatment events, or changing from heating to cooling and vice versa.

[0048] In some forms, the method further comprises terminating or reducing the temperaturebased treatment if sensor data indicates that the user’s sleep quality or physiological state is adversely affected by the treatment.

[0049] In some forms, the method further comprises: storing historical sensor data and user responses to adaptively refine future temperature-based treatments for the user.

[0050] In some forms, the temperature-based feedback is provided in combination with at least one other form of feedback selected from the group consisting of: audio feedback, tactile feedback, or visual feedback, to further prompt the user to change position.

[0051] 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

[0052] One or more forms of the present technology will hereinafter be described with reference to the accompanying Figures, in which:

[0053] 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;

[0054] Fig. 2 is a process flowchart for treating a user for sleep disordered breathing according to some forms of the present technology;

[0055] Fig. 3 is a perspective view of an example system component for treating a user for a sleep disordered breathing in the form of a mattress cover in an example environment according to some forms of the present technology;

[0056] Fig. 4 is a top view of Fig. 3;

[0057] Fig. 5 is a perspective view of an example system component for treating a user for sleep disordered breathing in the form of a pillow, pillow insert or cover according to some forms of the present technology;

[0058] Fig. 6 is a top view of the example system component of Fig. 5 according to some forms of the present technology;

[0059] Fig 7 is a perspective view of the example system component of Figs 5 and 6 in an example environment according to some forms of the present technology;

[0060] Fig. 8 is a top view of Fig. 7;

[0061] Fig. 9 is yet another example system component for treating a user for sleep disordered breathing in the form of a wearable chest or waist strap according to some forms of the present technology.

[0062] 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 thecontrary, 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

[0063] 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.

[0064] 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.

[0065] 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 individualmay benefit from sleeping in a reclined position rather than completely horizontal relative to ground.

[0066] 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.

[0067] 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.

[0068] 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.

[0069] 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 whocould have a more comfortable option (e.g., lower pressure in Positive Airway Pressure (PAP) machine, smaller displacement in mandibular repositioning devices, etc.).

[0070] 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 regulate temperature at one or more specific areas of the user’s body. This 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 temperature 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 temperature 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 temperature control only when beneficial, and adaptively optimizes the control process based on the user’s actual response.

[0071] FIG. 1 illustrates an example system 100 for treating sleep-related breathing disorders through adaptive positional therapy. The system 100 is configured to acquire and process data to monitor the user’s condition, and to control temperature at targeted regions of the user’s body in response to identified conditions. The system is organized into several functional modules, each responsible for acquiring and processing specific types of user data.

[0072] The data acquisition arrangement 102 includes a condition monitoring module 104, a sleep data module 106, and an environment and temperature module 108. The condition monitoring module 104 is responsible for gathering data on respiratory events, snoring, and body position. The sleep data module 106 is dedicated to acquiring data related to sleep quality and may include sleep stages. The environment and temperature module 108 monitors the temperature at various regions of the user’s body and the surrounding environment. Data from these modules are provided to a controller 112, which processes the information to determine whether the user is experiencing a condition that may benefit from positional therapy, such as snoring while supine.

[0073] The condition monitoring module 104 may utilise a range of sensors to detect and characterize the user’s body position, movement, and respiratory activity. These sensors may include accelerometers and gyroscopes for detecting body orientation and movement, microphones for capturing snoring and respiratory sounds, and pressure sensors for monitoring contact and load distribution on bedding or wearable devices. This module enables the system to identify when the user is in a supine or lateral position and to detect the presence and severity of snoring or sleep-disordered breathing events.

[0074] In some forms, at least some of the sensors of the condition monitoring module 104 may be incorporated in ear worn devices, such as earbuds, disclosed in co-pending application PCT / IB2025 / 000432, the contents of which are herein incorporated by cross reference. These earbuds are capable of detecting the user’s head position and orientation, monitoring for snoring and respiratory sounds, and capturing additional biometric signals such as movement and oxygen saturation. The earbuds can distinguish between supine, prone, and lateral sleep positions, and can correlate detected respiratory events or snoring with the user’s posture. By leveraging the proximity of the earbuds to the upper airway and head, the system can achieve high-fidelity detection of sleep disordered breathing events and positional changes, thereby enhancing the accuracy and responsiveness of the condition monitoring module.

[0075] The sleep data module 106 is configured to monitor and analyze sleep quality and sleep architecture throughout the sleep session. This module may employ physiological sensors such as heart rate sensors, pulse oximeters, electroencephalography (EEG) sensors, electrooculography (EOG) sensors, and electromyography (EMG) sensors. EEG sensors are used to detect brainwave patterns, EOG sensors monitor eye movements, and EMG sensors assess muscle tone, enabling accurate classification of sleep stages. Additional signals, such as heart rate variability, blood oxygen saturation, and skin or core body temperature, may be used to further assess sleep quality and detect arousals or disturbances.

[0076] Sleep is typically divided into non-REM (NREM) and REM stages, with NREM further subdivided into N1 (lightest sleep), N2 (light sleep with characteristic spindles and K- complexes), and N3 (deep or slow-wave sleep). REM sleep is characterized by rapid eye movements and brain activity similar to wakefulness. The system’s sleep data module 106 enables the detection and tracking of these stages, providing a comprehensive profile of the user’s sleep cycles, sleep efficiency, and the occurrence of arousals or disruptions.

[0077] The environment and temperature module 108 includes sensors for monitoring both the user’s skin and the temperature delivered by the control elements, as well as ambient environmental conditions. Temperature sensors may be embedded in bedding, wearable devices, or positioned in the user’s environment to provide real-time data on thermal conditions relevant to both comfort and therapy.

[0078] The system 100 further comprises a temperature control arrangement 110, which includes one or more heating and / or cooling elements integrated into bedding, wearable devices, or other user-contacting structures. The temperature control arrangement 110 is configured to apply localised temperature changes to specific regions of the user’s body, such as the torso, neck, or limbs, under the direction of the controller 112. The controller 112 initiates the temperature control process when a monitored condition meets predefined criteria for positional therapy intervention, and may also consider sleep stage and quality data to optimise timing and minimise sleep disruption.

[0079] The controller 112 comprises one or more processors configured to execute machine- readable instructions stored in memory. Upon detection of a target condition, the controller 112 activates the temperature control arrangement 110 to deliver heating or cooling to one or more regions of the user’s body. After the control process has been in effect for a predetermined period, the controller 112 evaluates sensor data to determine whether the user’s position or respiratory condition has changed as intended, and may also monitor for any adverse impact on sleep quality or stage transitions. If the desired change is not detected, or if sleep quality is negatively affected, the controller 112 adaptively modifies the temperature control parameters — such as increasing the intensity, changing the location, or adjusting the duration of heating or cooling — until the monitored data indicate that the user’s position or condition has improved without undue sleep disruption.

[0080] The system may be configured in some forms of the technology to deliver an intervention or stimuli of sufficient intensity to intentionally rouse the user from sleep when a persistent or severe condition is detected. For example, if repeated temperature-based interventions fail to resolve a significant respiratory event or positional issue, the controller 112 may escalate the feedback — such as by increasing the temperature differential, activating additional sensory cues (e.g., vibration, audio alerts), or combining modalities — to induce a brief awakening or arousal. This controlled rousing may serve as a safety mechanism to reducethe severity or duration of sleep-disordered breathing events, or to prompt the user to consciously adjust their position. By incorporating the ability to escalate feedback to the point of arousal, the system provides an additional layer of protection and therapeutic efficacy, particularly for users at risk of prolonged or unresponsive respiratory disturbances during sleep.

[0081] The various modules and components of the system 100 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.

[0082] As such, the condition of the user being monitored may be broadly based and include 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 information 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.

[0083] This condition monitoring information 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 some implementations, if one of the conditions identified from the condition monitoring module is that the position of the user is in a predetermined target position then controller 12 instigates the temperature regulation to guide them to change position from that predetermined target position. The system 100 may be arranged to apply this intervention even if a breathing disorder event has not occurred, if it determines that such an event is likely to occur (say from past historical data) or from monitored data. Using temperature management to guide the user to change positions may be less disruptive thereby assisting the user to change positions without altering their sleep state substantively. Furthermore, users may not respond to audio, visual or haptic feedback, especially in some deep phrases of sleep, and therefore may be more responsive to temperature-based feedback due to autonomic responses of the body.

[0084] The controller 112 serves as the central processing unit of the system, receiving and analysing data from the various sensors incorporated in the data acquisition arrangement 102. The controller is configured to process sensor data in real time to determine whether a target condition is present. Such target conditions may include, for example, a target position of the user, the detection of snoring while the user is in a supine position, or the occurrence of sleep- disordered breathing events that are known to be responsive to positional therapy.

[0085] Upon identification of a target condition, the controller 112 initiates a control process to regulate the temperature at one or more specific regions of the user’s body. The controller determines which regions require intervention and selects appropriate parameters for the temperature control arrangement 110, such as the intensity, duration, and location of heating or cooling. The temperature control is applied with the aim of prompting the user to change position and thereby alleviate the detected condition.

[0086] The controller 112 receives feedback from the sensors during and after the temperature control process. This feedback includes updated information on the user’s body position, respiratory activity, and the status of the monitored condition. The controller evaluates whether the applied temperature control has resulted in the desired change, such as a shift from a supine to a lateral position or a reduction in snoring or respiratory events.

[0087] If the feedback from the sensors indicates that the target condition persists or that the user’s position has not changed as intended, the controller 112 adaptively modifies the temperature control parameters. This adaptive process may involve increasing the intensity of heating or cooling, altering the location of temperature application, or adjusting the duration or timing of the control process. The controller may repeat this cycle of intervention and feedback analysis until the monitored data confirm that the user’s position or condition has improved.

[0088] The controller 112 may be programmed to ensure that temperature control is only applied when a monitored condition is likely to benefit from positional therapy, thereby minimising unnecessary intervention. The controller may also store historical sensor data and user responses to optimize future interventions and personalise the control strategy for individual users.

[0089] The controller may further incorporate safety protocols to prevent excessive heating or cooling and to ensure user comfort. Temperature limits and maximum intervention durations may be predefined, and the controller will override or terminate the control process if these thresholds are reached.

[0090] The controller 112 may be implemented using one or more processors executing machine-readable instructions stored in local or remote memory. The controller may also communicate wirelessly with external devices for remote monitoring, data logging, or integration with other therapeutic or diagnostic systems.

[0091] In some embodiments, the controller may utilize machine learning algorithms to analyse sensor data and user responses over time, enabling the system to refine its intervention strategies and improve therapeutic outcomes. The controller may identify patterns in the user’s sleep behaviour and responsiveness to positional therapy, allowing for increasingly personalised and effective control.

[0092] The controller may manage multiple sensor inputs and coordinate the operation of distributed temperature control elements across different regions of the user’s body. This allows for targeted and efficient intervention, tailored to the specific needs and conditions of the user at any given time.

[0093] The controller may also provide alerts or notifications to the user or a caregiver if persistent target conditions are detected or if the system is unable to achieve the desired positional change after repeated interventions.

[0094] The controller’s architecture is designed for scalability and flexibility, supporting a range of system configurations, from single-device implementations to distributed networks of sensors and actuators integrated into bedding, wearables, or other user-contacting structures.

[0095] The controller’s decision-making process may be logged for review by clinicians or researchers, supporting ongoing evaluation and improvement of the system’s performance. The information of the efficacy of the system, may be based on monitoring the condition of the user 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 intervention 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 treatment can be tailored to the user.

[0096] The controller may also interface with user applications or external health platforms, enabling users to review their sleep data, receive personalised recommendations, or share information with healthcare providers.

[0097] In the implementation depicted in FIG. 1, the system 100 may include a user device or mobile computing device 130, such as a smartphone, tablet, or dedicated controller, which communicates with the sensors and temperature control elements of the system. The user device 130 may serve as an interface for system setup, monitoring, and data review, and may facilitate wireless communication with the controller 112 and other system components. The user device 130 may display real-time or historical data regarding the user’s sleep position, respiratory events, and the operation of the temperature control process.

[0098] The user device 130 may be configured to receive data from the sensors embedded in bedding, wearable devices 150, or other user-contacting structures. This data may include information on body position, snoring, respiratory activity, and temperature at various regions of the user’s body. The user device 130 may also receive notifications or alerts generated by the controller 112, such as when persistent target conditions are detected or when the system has initiated or adapted a temperature control process.

[0099] In some embodiments, the user device 130 may allow the user or a caregiver to review summaries of system interventions, including when and where temperature control was applied, the user’s response, and any adaptive changes made by the controller. The device may also provide access to safety settings, such as maximum allowable temperature ranges or intervention durations, and may enable remote adjustment of system parameters within predefined limits.

[0100] The user device 130 may further support the remote monitoring and data sharing, allowing clinicians or caregivers to access relevant information for ongoing assessment and optimisation of therapy.

[0101] Data may be securely transmitted to external health platforms or cloud-based services for long-term storage, analysis, or integration with other therapeutic or diagnostic systems.

[0102] In some implementations, the user device 130 may be used to update or reprogram the controller 112, enabling the deployment of new algorithms, safety features, or therapeutic protocols as advancements in sleep medicine and positional therapy become available. The device may also facilitate user feedback, allowing users to report comfort levels, perceived effectiveness, or any adverse events, which can be incorporated into the system’s adaptive control strategy.

[0103] The architecture of the user device 130 is designed for flexibility and scalability, supporting a range of system configurations from single-user home environments to multi-user clinical settings. The user device may be implemented as a standalone application, a component of a broader health management platform, or as an integrated part of the system’s hardware, ensuring seamless interaction with the controller 112 and other system components for the delivery of personalized, adaptive positional therapy.

[0104] FIG. 2 schematically depicts an embodiment of the processing performed by the controller 112 of the system 100, illustrating the stepwise flow of data acquisition, analysis, intervention, and feedback. The process begins with the acquisition of multi-modal data from the user via the data acquisition arrangement 102, which includes the condition monitoring module 104, sleep data module 106, and environment and temperature module 108.

[0105] In Step SI, the system continuously or periodically acquires sensor data relating to the user’s body position, movement, respiratory activity, snoring, and environmental conditions. Simultaneously, in Step S2, the sleep data module 106 collects physiological signals such as EEG, EOG, EMG, heart rate, pulse oximetry, and temperature to monitor sleep quality and determine the user’s current sleep stage (e.g., NREM, REM, or wake).

[0106] In Step S3, the controller 112 synchronizes and preprocesses the incoming data streams, aligning the time stamps and filtering out noise or artifacts. This ensures that all relevantphysiological, behavioural, and environmental data are temporally correlated for accurate analysis.

[0107] In Step S4, the controller 112 analyses the synchronized data to detect the presence of a target condition. This may include identifying snoring or sleep-disordered breathing events, determining the user’s sleep stage, and assessing whether the user is in a position (such as supine) that is known to exacerbate respiratory events.

[0108] If a target condition is detected, the process advances to Step S5, where the controller 112 initiates a control process to regulate temperature at one or more specific regions of the user’s body. The controller determines the optimal location, intensity, and duration of heating or cooling, taking into account the user’s current sleep stage and the potential impact on sleep quality.

[0109] In Step S6, the temperature control arrangement 110 is activated, and the system continues to monitor the user’s physiological and environmental data in real time. The controller 112 evaluates whether the intervention has resulted in the desired outcome, such as a change in body position, reduction in snoring, or improvement in respiratory patterns, while also monitoring for any adverse effects on sleep quality or arousals.

[0110] If the monitored data indicate that the user’s position or condition has not improved, or if sleep quality is negatively affected, the process proceeds to Step S7. Here, the controller 112 adaptively modifies the temperature control parameters — such as increasing the intensity, changing the location, or adjusting the duration of heating or cooling — and may repeat the intervention and feedback cycle as needed.

[0111] Throughout the process, the system may also log user responses, sleep stage transitions, and intervention outcomes for future analysis and personalization. In Step S8, the controller 112 determines whether the intervention has been successful or if escalation (such as rousing the user) is required. The process then either returns to ongoing monitoring or escalates the intervention as appropriate.

[0112] This stepwise, closed-loop processing framework enables the system to integrate realtime sleep monitoring, targeted temperature -based positional therapy, and adaptive feedback,ensuring that interventions are both effective and minimally disruptive to the user’s sleep architecture.

[0113] In some embodiments, the system employs machine learning algorithms to enhance the detection of target conditions and to optimize the effectiveness of temperature-based positional therapy. The controller 112 receives and processes multiple streams of sensor data, including body position, respiratory activity, snoring intensity, environmental parameters, and sleep data acquired from the sleep data module.

[0114] The algorithmic framework for the system may include several components. First, a condition detection module utilises supervised or semi-supervised learning models — such as decision trees, support vector machines, or neural networks — to classify sensor data and identify when a target condition is present. The model may use features extracted from the sensor data, including sleep stage transitions, sleep fragmentation, and physiological markers of arousal, to improve the accuracy of condition detection. For example, the model may be trained to recognize patterns associated with snoring in a supine position during NREM sleep, apneic events, or other sleep-disordered breathing episodes that are likely to benefit from positional therapy.

[0115] Once a target condition is detected, the system initiates the temperature control process and begins monitoring the user’s response. An effectiveness evaluation module analyses subsequent sensor data, including ongoing sleep data, to determine whether the intervention has resulted in the desired outcome, such as a change in body position, reduction in snoring, or improvement in respiratory patterns, while also assessing whether sleep quality or sleep stage continuity is maintained. This module may employ statistical analysis, pattern recognition, or reinforcement learning techniques to assess the impact of the temperature control. For example, the system may compare pre- and post-intervention features — such as the angle of body rotation, snoring decibel levels, respiratory event frequency, and sleep stage stability — to determine if a meaningful improvement has occurred.

[0116] If the system determines that the temperature control has not been effective, or if the intervention is causing sleep disruption or arousals, an adaptive control module is engaged. This module uses feedback from the sensors and sleep data to adjust the parameters of the temperature control process, such as increasing the intensity, changing the location, orextending the duration of heating or cooling. The adaptation may be guided by reinforcement learning algorithms, which iteratively update the control strategy based on observed outcomes, including sleep stage transitions and arousal events. The system may assign reward values to successful interventions that improve both respiratory condition and sleep quality, and penalize ineffective or disruptive ones, gradually learning the optimal set of control actions for each user and condition.

[0117] The machine learning system is designed to integrate multiple sensor inputs and contextual data, including detailed sleep architecture, to create a robust, intelligent platform. In addition to physiological and environmental data, the system may incorporate user-specific factors such as age, sleep history, and prior responsiveness to therapy. Over time, the model can be refined using user-specific data, allowing for increasingly personalised and effective interventions that are sensitive to the user’s sleep patterns and needs.

[0118] The system may also employ unsupervised learning techniques to discover new patterns or clusters in the data that are predictive of therapy outcomes. For example, clustering algorithms may identify subgroups of users who respond similarly to certain temperature control strategies, or who exhibit similar sleep stage responses to interventions, enabling the system to recommend tailored interventions for different user profiles.

[0119] The system may be capable of continuous learning and self-improvement. As more data are collected from ongoing use — including detailed sleep data, intervention outcomes, and user feedback — the machine learning models are retrained or updated to reflect the latest user responses and environmental conditions. This enables the system to adapt to changes in user behaviour, sleep patterns, or health status, maintaining high levels of accuracy and therapeutic benefit.

[0120] The machine learning framework also supports safety and compliance features. The system can detect anomalous sensor readings, unexpected user responses, or sleep disruptions, triggering alerts or safety shutdowns as needed. It can also log intervention outcomes, sleep stage transitions, and user feedback, providing valuable data for clinicians or researchers to further refine therapy protocols.

[0121] As the system accumulates more user data, including longitudinal sleep monitoring, it can leverage population-level insights to further enhance its predictive capabilities and intervention strategies, ensuring that both new and experienced users benefit from the most effective and up-to-date therapy protocols.

[0122] The machine learning modules may be implemented locally on the controller 112 or remotely via secure cloud-based services, depending on system configuration and privacy requirements. In either case, data security and user confidentiality are maintained in accordance with applicable regulations and best practices.

[0123] The system may utilise population-based data to supplement or initialize its algorithms, particularly when user-specific data is limited or unavailable. A database of population-level information, including demographic factors, sleep patterns, and typical responses to positional therapy, can be accessed by the controller 112 to establish baseline intervention strategies. The population data may be segmented into subgroups based on characteristics such as age, gender, body type, or sleep disorder classification, allowing the system to tailor initial control parameters to the most relevant cohort. In addition to informing baseline control strategies, population data may be analysed to recognize patterns and conditions that have been shown to respond effectively to positional therapy. For example, the system may identify that snoring in a supine position or certain types of sleep-disordered breathing events are more likely to benefit from temperature-based positional interventions, based on aggregated outcomes from similar users. This enables the system to prioritize and target interventions for conditions with demonstrated therapeutic efficacy, even before sufficient individual data is available. Furthermore, population data can be leveraged to refine the adaptive control process, providing reference models for how temperature control parameters — such as intensity, duration, and location — can be adjusted in response to specific conditions and user responses. By comparing individual user data to population-level trends, the system can more effectively calibrate its adaptive algorithms, ensuring that interventions are both evidence-based and tailored to the user’s evolving needs. As the system accumulates individual user data through ongoing monitoring and intervention, the algorithms are progressively refined to reflect the user’s unique physiological and behavioural responses. This approach ensures that the system delivers effective positional therapy from the outset, while enabling increasingly personalised and adaptive control as more user-specific data becomes available.

[0124] The temperature control arrangement 110 may be implemented in a variety of physical forms, including a mattress cover or topper 200 (as illustrated in FIGS. 3 and 4), a pillow, pillow insert, or pillow cover 300 (as illustrated in FIGS. 5 to 8), or a wearable strap or band, such as a chest or waist strap 400 (as illustrated in FIG. 9). Each embodiment is designed to deliver targeted temperature-based interventions to specific regions of the user’s body to prompt beneficial changes in position and manage sleep-related breathing disorders.

[0125] In some forms, the temperature control arrangement 110 is capable of applying both heating and cooling to one or more regions of the user’s body simultaneously. Heating and / or cooling may be affected using integrated devices such as resistive heating wires, Peltier cells, or fluid-based thermal channels. These elements 210, 310, 410 can be distributed throughout the device in a grid or other arrangement, allowing for precise and localised temperature control. The regions targeted for temperature regulation can include at least part of the torso, legs, arms, neck, and head. Temperature-based control may be applied to the front, rear, or sides of these regions, and the system may be configured to deliver temperature changes to multiple areas at once or to specific areas as needed.

[0126] The elements 210, 310, 410 may be located at equidistantly spaced positions or in a denser configuration around particular body regions, depending on therapeutic requirements. For example, the mattress cover 200 may have more densely spaced feedback generators around the torso and fewer around the feet or legs, while the pillow 300 may have a higher density of elements around the neck region. This arrangement allows the system to selectively heat or cool one side or region of the device to encourage the user to turn from a supine to a lateral position, or to guide the user into or out of a particular posture. For instance, one side of the mattress or pillow may be heated while the opposite side is cooled, or portions near the feet may be regulated to prompt the user to curl into a foetal or side-sleeping position.

[0127] The system may be designed to accommodate user preferences and environmental conditions. For example, a user may be drawn toward or away from heated or cooled regions depending on ambient temperature or personal comfort, and the system can adapt its control strategy accordingly. All heating and cooling elements are insulated and controlled to ensure user safety and comfort, and the devices may be designed for portability and compatibility with a range of bedding and sleep environments.

[0128] It is envisaged that the temperature control arrangement 110 could be in other forms, such as eye masks, blanket or doona, or clothing such as pyjamas, or other devices and apparatus that are normally used with the user in a sleep environment. A mattress cover 200, pillow or pillow cover 300, clothing or other portable devices may be considered more desirable due to their portability especially for users who have active lifestyles and may sleep in different locations or travel for work or leisure.

[0129] 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 can also provide non-temperature-based interventions. These interventions could include but not limited to being audio-based, including alerts, music or speech, light-based, such as strobing, flashing or constant light, or tactile interventions. The tactile interventions can be delivered by haptic motors, while the audio feedback can be delivered by speakers, or lights. The light-based interventions can be delivered by LEDs or display screens. The audio, haptic or light-based interventions can be delivered by speakers, displays or haptic motors including those in an associated smart portable device, or in headphones or earbuds or contained in a primary product such as in the mattress, pillow, mattress cover or pillow cover, pillow insert or pillowcase.

[0130] The non-temperature-based feedback may also include feedback delivered by inflatable portions in the mattress, mattress cover, pillow insert or pillow cover. By inflating or deflating the inflatable portions, the system can also deliver more effective changes in the user by 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.

[0131] The user application 135 is provided as an executable program for a mobile device, such as a smartphone or tablet, and may also be available for a wearable device. The application is designed to facilitate user interaction with the system, including initial setup, data review, and limited user input. The user application may provide a simple interface for receiving system notifications, reviewing summaries of interventions, and entering subjective feedback such as comfort ratings or sleep quality assessments.

[0132] In some embodiments, the user application may prompt the user to provide information relevant to system operation, such as sleep and wake times, or to respond to alerts generated by the system. The application may also display basic recommendations or insights generated by the controller, such as suggestions to adjust sleep position or feedback on recent interventions.

[0133] The user application is designed to be user-friendly and may be customized based on device capabilities and user preferences. In certain forms, the application may support secure data sharing with caregivers or clinicians, subject to privacy and security requirements. The application may also allow the user to review historical data, intervention outcomes, and system status in a clear and accessible format.

[0134] As set forth above, the data acquisition arrangement 102 is configured to gather data for determining whether a target condition for positional therapy is present. Data collection may be continuous, with sensors operating throughout the sleep session or over extended periods to provide ongoing monitoring of the user’s state. This approach enables the system to detect changes in position or the onset of conditions such as snoring or sleep-disordered breathing events in real time, and to maintain a comprehensive record of the user’s sleep patterns and responses to interventions.

[0135] Alternatively, data gathering may be event-driven, commencing in response to a trigger event. For example, the system may initiate more frequent or detailed data collection when a preliminary indication of snoring, abnormal respiratory activity, or a change in body position is detected by a low-power or background sensor. Triggered data collection allows the system to conserve resources while still capturing high-resolution data during periods of interest, such as when a target condition is suspected or when a temperature control intervention is initiated.

[0136] In addition to sensor-based data, the system may incorporate user input to supplement or clarify the sensed data. The user application 135 may prompt the user to provide subjective information, such as perceived sleep quality, comfort, or the occurrence of specific symptoms. Users may also manually indicate their position, report awakenings, or log relevant events through the application interface. This user-supplied information can be correlated with sensor data to improve the accuracy of condition detection and to personalize the system’s response.

[0137] The data acquisition arrangement 102 may also be configured to synchronize and integrate data from multiple sources, ensuring that information on body position, respiratory activity, and environmental conditions is temporally aligned. This enables the controller 112 to accurately assess the user’s state at any given time and to determine the effectiveness of positional therapy interventions.

[0138] The system may further process the collected data to filter out noise, compensate for missing values, and extract relevant features such as position changes, snoring episodes, or respiratory rate variability. These processed data streams are then analysed by the controller 112 to establish whether a target condition is present and to monitor the user’s response to temperature-based control processes.

[0139] The system may include the capability to monitor the user’s body temperature at one or more regions, enabling precise and adaptive application of heating or cooling. A plurality of temperature sensors 212, 312, 412 may be integrated within the environmental conditioning device — such as the mattress cover, pillow, or strap — or positioned in proximity to the user’s body. These sensors can be distributed to monitor temperature at the torso, limbs, neck, head, or other relevant regions, and may also measure the temperature being applied under the temperature control arrangement 110 or the surrounding environment. Other sensors 214, 314, 414, may be integrated into the components of the temperature control arrangements (mattress cover, 200, pillow cases or covers 300 , wearable straps 400) for monitoring information on the condition of the user or user’s environment of the user can include pressure sensors, audio and light collecting sensors, position sensors such as accelerometers, gyroscopes or cameras, heart rate monitors, microphones, respiratory sensors and oximeters. A set forth herein some of these are sensors may be integrated in other devices (wearable or other separate devices).

[0140] Similarly it is also expected that the system using temperature change to guide positional change as described herein can be used in combination with a sleep-aid systems utilising flexible contacting structures as described in the co-pending PCT applications filed by the applicants on 29 October 2025, claiming common priority to the present application, and entitled A SYSTEM and METHOD FOR TREATING SLEEP DISORDERED BREATHING, the contents of which are herein incorporated by cross reference. The sleep aid systems as described in these co-pending applications utilise flexible head-contacting structure and / or a flexible body-contacting structure, can be used with the systems described herein to form asingle system which can provide a more complete sleep-aid system which can address the sleep-related respiratory disorders more effectively.

[0141] The temperature data acquired from these sensors is used by the controller to determine the user’s current thermal state and to guide the application of temperature changes. For example, the system may be configured to apply heating or cooling to a specific region so as to achieve a predetermined number of degrees above or below the measured body temperature, or to maintain a target temperature differential relative to the ambient environment.

[0142] In addition to integrated sensors, the system may receive temperature or physiological data from external wearable devices 150, such as smart watches, smart rings, or other health monitoring devices. These external devices may communicate sensor information to the system via a wireless communications interface, allowing for a more comprehensive assessment of the user’s condition. In some embodiments, sensor data from other medical devices, such as positive airway pressure (PAP) machines, may also be incorporated to further inform the system’s control strategy. The wearable or separate medical device data may be integrated into the data acquisition arrangement via the user application 135 or the user device 130 or through a separate communication system

[0143] Accordingly, the present technology relates to systems and methods for treating sleep- related respiratory disorders and sleep disturbances by employing positional therapy, wherein temperature regulation is used as a non-invasive means to prompt beneficial changes in user position. The system is designed to monitor the user’s condition — such as body position, snoring, sleep quality and respiratory events — using one or more sensors integrated into wearable devices, bedding, or other user-contacting structures.

[0144] When a target condition is detected, the system initiates a control process to regulate temperature at one or more specific regions of the user’s body. This temperature regulation, which may involve localised heating or cooling, is applied with the aim of prompting the user to change position, thereby alleviating the detected condition.

[0145] The system operates in a closed-loop manner, receiving feedback from the sensors to determine whether the temperature control has resulted in the desired positional change or improvement in the user’s condition. If the monitored data indicate that the user’s position orcondition has not improved, the system adaptively modifies the temperature control parameters — such as intensity, duration, or location — until the monitored data confirm that the user’s position or respiratory state has improved.

[0146] The system is capable of distinguishing between conditions that are likely to benefit from positional therapy and those that are not, thereby minimising unnecessary interventions. The temperature-based positional therapy may be selectively applied only when a monitored condition is amenable to such intervention, improving therapeutic effectiveness and user comfort.

[0147] Through this adaptive approach, the system provides a non-invasive, user-specific solution for managing sleep disorders, particularly those exacerbated by body position. By leveraging temperature regulation as a positional therapy tool, the system offers an alternative or adjunct to conventional treatments, supporting improved sleep quality and respiratory health for individuals affected by sleep-related disorders.

[0148] In some embodiments, the positional therapy systems described herein may be used in combination with other established respiratory therapies to enhance overall treatment efficacy and patient comfort. For example, the positional therapy systems disclosed herein, may be used as an adjunct to PAP therapy. For example, the system may be configured to detect when a user is experiencing residual apneic events or snoring despite the use of PAP and selectively apply temperature-based positional therapy to further reduce airway obstruction. This combined approach may improve therapeutic outcomes for users who are suboptimally controlled on PAP alone or who experience positional OSA.

[0149] Overall, the integration of temperature-based positional therapy with other respiratory therapies provides a comprehensive, user-centered approach to the management of sleep- related and respiratory disorders. By addressing both the mechanical and positional contributors to airway patency and respiratory function, the disclosed systems offer the potential for improved patient adherence, comfort, and clinical outcomes across a broad spectrum of respiratory care scenarios.

[0150] 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, theword “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 system for treating a user with sleep disordered breathing, comprising; one or more sensors configured to generate condition data associated with a condition of the user; a temperature control arrangement configured to apply heating and / or cooling to at least one region of the user; 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; determine if a condition of the user, based on the condition data, corresponds to at least one target condition associated with the user’s sleep disordered breathing; and when the user is determined to be in the at least one target condition, cause the temperature control arrangement to instigate a temperature 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.

2. A system according to claim 1, 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.

3. The system according to either claim 1 or 2, wherein the control system is configured to: receive condition data from the one or more sensors during the temperature 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 temperature control arrangement to adaptively adjust at least one parameter of the temperature based treatment.

4. The system of claim 3, wherein the at least one parameter comprises at least one of: the intensity of heating or cooling, the duration of application, the location of temperature delivery, or the timing of temperature control events.

5. A system for treating a user with sleep disordered breathing, comprising;one or more sensors configured to generate condition data associated with a condition of the user, the condition data comprises physiological data associated with the breathing of the user, and position data associated with the sleeping position of the user; a temperature control arrangement configured to apply heating and / or cooling to at least one region of the user; 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, determine if a condition of the user, based on the condition data, corresponds to at least one target condition associated with the user’s sleep disordered breathing, the target condition including the position of the user; and when the user is determined to be in the at least one target condition, cause the temperature control arrangement to: instigate a temperature 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; and adjust at least one parameter of the temperature based treatment if the position of the user remains unchanged after an elapsed time period.

6. The system of claim 5, wherein the at least one parameter comprises at least one of: the intensity of heating or cooling, the duration of application, the location of temperature delivery, or the timing of temperature control events.

7. The system of any one of claims 3 to 6, wherein the control system is configured to cause the temperature control arrangement to alternate between heating and cooling, or to apply heating and / or cooling to different regions of the user’s body, in response to the user’s lack of response to a temperature based treatment in a previous period.8 The system of any one of claims 3 to 7, wherein the control system is configured to cause the temperature control arrangement to alternate the intensity of heating and / or cooling in response to the user’s lack of response to a temperature based treatment in a previous period9. The system of claim 7 or 8, wherein the determination of the user’s lack of response is based on monitoring changes of position of the user.

10. The system of claim 7 or 8, wherein the determination of the user’s lack of response is based on changes of physiological data associated with the breathing of the user.

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. A system according to claim any preceding claim, wherein the control system is configured to receive sleep data measuring one or more physiological parameters of the user correlated with sleep quality.

13. A system according to claim 12, wherein the control system utilises the sleep data to determine if a condition of the user corresponds to at least one target condition and / or a parameter of the temperature based treatment at the at least one region of the user under the temperature control arrangement.

14. A system according to any preceding claim, wherein the control system is configured to receive temperature data from one or more sensors configured to measure the body temperature of the user.

15. A system according to claim 14, wherein a characteristic of the regulation of the temperature at the at least one region of the user includes heating or cooling a predetermined amount above or below the measured body temperature of the user.

16. A system according to any preceding claim, wherein the control system is further configured to receive environmental data from one or more sensors configured to measure at least one of light exposure, temperature, or humidity in the user’s environment.

17. A system according to claim 17, wherein a parameter of the temperature based treatment at the at least one region of the user is dependent on a measured characteristic of the environmental data.

18. A system according to any one of the preceding claims, wherein the target condition is associated with one or more of: a condition relating to the position of the user; a condition relating to the respiration of the user; a condition relating to interruptions in sleep of the user; a condition relating to snoring of the user; a condition relating to snoring magnitude of the user; or a condition relating to snoring frequency of the user.

19. The system of any preceding claim, wherein the control system is configured to terminate or reduce the temperature event if sensor data indicates that the user’s sleep quality or physiological state is adversely affected by the event.

20. The system of any one of claims 10 to 13, wherein the control system is configured to store historical sensor data and user responses temperature based treatment to adaptively refine future temperature based treatments for the user.

21. A method for treating a user for sleep disordered breathing, the method comprising: receiving condition information from at least one sensor configured to sense condition information relating to at least one condition of the user; determining if a condition of the user during a sleep session, based on the condition information, corresponds to at least one target condition associated with the user’s sleep disordered breathing; and when it is determined that the condition of the user is in one of the at least one target condition, providing a temperature based event to the user for guiding the user to change sleeping position as therapy for the user’s sleep disordered breathing.

22. The method of claim 21, further comprising: applying heating or cooling to at least one region of the user’ s body in response to the determination that the user is in the target condition.

23. The method of claim 21 or 22, further comprising: receiving body temperature information from at least one sensor, and wherein the application of the temperature change includes heating or cooling a predetermined amount above or below a measured body temperature of the user.

24. The method of any one of claims 21 to 23, further comprising: receiving environmental temperature information and wherein the application of the temperature change depends on the ambient temperature of the user’s environment.

25. The method of any one of claims 21 to 24, wherein the temperature-based treatment is applied by a system having a plurality of heating or cooling elements, and wherein the elements are selectively activated to target specific regions of the user’s body.

26. The method of any one of claims 21 to 25, further comprising: monitoring the user’s position and / or respiratory condition after the application of the temperature-based treatment for an elapsed period, and adaptively adjusting at least oneparameter of the temperature-based treatment based on feedback received from the at least one sensor that the target condition persists.

27. The method of claim 26, wherein adaptively adjusting the temperature -based treatment comprises at least one of: increasing the intensity of heating or cooling, increasing a length of the application, decreasing a duration between treatment events, or changing from heating to cooling and vice versa.

28. The method of any one of claims 21 to 27, further comprising: terminating or reducing the temperature-based treatment if sensor data indicates that the user’s sleep quality or physiological state is adversely affected by the treatment.

29. The method of any one of claims 21 to 28, further comprising: storing historical sensor data and user responses to adaptively refine future temperature-based treatments for the user.

30. The method of any one of claims 2 Ito 29, wherein the temperature-based feedback is provided in combination with at least one other form of feedback selected from the group consisting of: audio feedback, tactile feedback, or visual feedback, to further prompt the user to change position.

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