WO2020115773A1

WO2020115773A1 - An apparatus and a method for detecting and providing therapeutic treatment for sleep disordered breathing

Info

Publication number: WO2020115773A1
Application number: PCT/IN2019/050893
Authority: WO
Inventors: Gunjanbhai Patel; Prashant Jha; Vijay HADDA
Original assignee: Secretary, Department Of Biotechnology
Priority date: 2018-12-07
Filing date: 2019-12-06
Publication date: 2020-06-11

Abstract

The present invention in its aspects provides an apparatus (100) and a method for detecting and rectifying sleep disordered breathing. The apparatus (100) comprises a pillow (110) comprising a head portion and a neck portion. The pillow (110) is provided a motion bio-sensor (150) and an active mechanism comprising Electro-Mechanical Angular Active Mechanism, EMAAM, (155) and Gear Integration Turning Assemble, GITA. Upon detecting the disordered movements and sounds, the pillow (110) activates the said active mechanism to adjust head-neck movements left/right side rotation for user to manage and restore breathing airflow (pharynx) without waking from sleep.

Description

AN APPARATUS AND A METHOD FOR DETECTING AND

PROVIDING THERAPEUTIC TREATMENT FOR SLEEP

DISORDERED BREATHING

FIELD OF INVENTION

The present disclosure relates to an apparatus for providing solution for people’s suffering from breathing disorders. More specifically, the present invention relates to an apparatus and a method for detecting condition of people suffering from sleep disordered breathing and providing rectification of the disorder, and evaluating information related to sleep quality.

BACKGROUND OF THE INVENTION

It is known that sleep is necessary and restorative to every individual and sleep greatly influences the quality of life. The human sleep/wake cycle generally conforms to a circadian rhythm that is regulated by a biological clock. Regular sleep enables the body and mind to refresh, rejuvenate and rebuild.

The prevalence of sleep disordered breathing affects more than 936 million people worldwide, according WHO 2007 report. However, the sleep disordered breathing is a respiratory system condition that affects at any age of people. Figure 1 shows the airflow in the respiratory tract of a person for normal conditions, when a person is snoring and during apnea. The sleep disordered breathing, including apnea and hypopnea, may be caused, for example, by an obstructed airway, or by derangement of the signals from the brain controlling respiration. Sleep disordered breathing is associated with excessive daytime sleepiness, a greater risk of high blood pressure, obesity, fatal heart conditions, Type-2 DM and stroke. An increased risk of behavior problems, such as aggression or learning problems in children with OSA, an increased risk of motor vehicle accidents due to lack of sleep. Untreated snoring and sleep apnea lead to high risk of other serious health complications and increases co-morbidity. The sleep disordered breathing may be identified by the acoustics of snoring or obstructive sleep apnea or upper airflow in respiratory tract or breathing pauses or vibration Sound of an anatomical structure in the upper pharyngeal airway.

Snoring and obstructive sleep apnea is a sleep disordered breathing characterized by pauses in breathing during sleep. Those affected by sleep apnea stop breathing during sleep numerous times during the night. Current treatments are ranging from drug intervention, positive airway pressure, upper airway stimulator implantable devices, oral appliances, to more surgical procedures. Positive airway pressure (PAP) therapy generally considered first-line therapy for the management of sleep-related breathing disorders and obstructive sleep apnea (OSA) syndrome. The common problem has been reported with PAP therapy include a leaky mask, trouble falling asleep, stuffy nose and a dry mouth because therapy devices use a mask and hose or nosepiece to deliver constant and steady air pressure either Continues or Bilevel PAP, it is not well tolerated by patients. The compliance for PAP therapy is often reported less than 60%. The oral appliances have also used an alternative to manage sleep apnea conditions, which are not as effective treatment, Jaw pain, soreness, or tension, Excessive salivation or even dry mouth and have a limited life expectancy. There is implantable hypoglossal electric stimulator device, but it is highly expensive, required upper airway surgery to treat, and makes it difficult to remove due to any internal scars, allergic and/or rejection response to the implanted electronics parts, infection and discomfort from the stimulation during sleep. In many of these instances, therapy compliance and patient acceptance are well below desired levels, an adaptation the current solutions ineffective as a long-term solution.

Sleep disordered breathing has been treated using a variety of patient-external and patient-internal therapy devices. Several devices have been disclosed in the past for treating sleep disorder. One such example is disclosed in the United States patent application 20140310878. In US20140310878, it is disclosed that a head support for stopping snoring of a sleeping individual, wherein the head support has a head resting surface for the head of a sleeping individual to rest on, including an active layer with an arrangement of neighboring deforming elements for controlling the height of the head support section by section, and a sensing layer which is arranged between the head resting surface and the active layer to detect a position of the head resting on the head resting surface.

Another example is disclosed in the United States patent application US20130245395A1. In US20130245395A1, it is disclosed that the present invention provides an improved pillow and mattress set to be used as a means for reducing snoring and obstructive sleep apnea during sleep by allowing a true prone position of the head. The pillow and mattress set further provides a support for lying with the body in a prone position. The pillow and mattress set comprises a pillow to support the head in a prone position and a mattress to support the body in a prone position, wherein the pillow and mattress are freely adjustable in relation to each other.

Another example is disclosed in the Korean patent KR101716262B1. In KR101716262B1, it is disclosed that the present invention relates to a multi-purpose functional pillow, and more particularly, to multi-purpose made to improve the blood circulation is irradiated with light, and can be the cervical spine massage using a fine vibration, adjustable height according to the user's body, such as young and old.

Another example is disclosed in the Korean patent KR101797189B1. In KR101797189B1, it is disclosed that the present invention relates to a smart pillow, in the pillow main body consisting of a shell surrounding the sponge, and the sponge has a cushion function supply the charged power from the power charger and the electric power charging unit for charging when supplied with power from outside a sleep monitoring unit that monitors the sleep state of the sleep in real time, and in a state configured on the other side of the pillow body, while driven according to an instruction the sleep monitoring unit to the air tube inside is formed at a side upper end of the shell automatically injected into the air or through a configuration including an electric air pump that drew, to clearly improve the factors that act as sleep disturbances depending on can determine based on the data objectify the sleep state information to provide a smart pillow which can lead to deep sleep do. Although the above disclosures are effective in treating sleep apnea or snoring, they have few limitations. For example, they do not disclose anything about monitoring conditions associated with sleep disordered breathing to provide feedback for enhanced therapy delivery. Further, they do not disclose detecting condition of people suffering from sleep disordered breathing and providing therapeutic treatment, and evaluating information related to sleep quality. Furthermore, nothing related to managing Apnea- hypopnea Index (AHI) index for OSA patients is addressed in prior art.

In view of the solutions disclosed hitherto, there is a dire need in the art to provide an apparatus which is capable of detecting condition of people suffering from sleep disordered breathing and providing a rectification to their condition. Further, it is desirable to evaluate the information (breathing pattern during sleep) and managing AHI index related to sleep quality.

SUMMARY OF THE INVENTION

The following disclosure presents a simplified summary of the invention in order to provide a basic understanding of some aspects of the invention. This summary is not an extensive overview of the present invention. It is not intended to identify the key/critical elements of the invention or to delineate the scope of the invention. Its sole purpose is to present some concept of the invention in a simplified form as a prelude to a more detailed description of the invention presented later.

It is one of the main objects of the present invention to provide an apparatus and a method to detect loud snoring and obstructive upper airflow or breathing pauses and provide a solution for sleep-disordered breathing.

It is another object of the present invention to provide an apparatus to detect the loud snoring or obstruction upper airflow in the supine position or prone position and manage restoring breathing airflow (pharynx) same time by adjusting the position of the head without waking from sleep. It is yet another object of the present invention to provide an apparatus for identifying sounds differentiating two different users snoring or obstructive upper airflow or breathing pauses in any sleep positions and tactile head-neck movements, wherein one of the users is a user of the herein disclosed Pillow and the other is a non-user.

It is a further object of the present invention to provide data analytics platform, a processing interface, sleep quality assessment and prediction trend with sleep report in order to provide objective assessment of healing, determine the effectiveness and AHI index score.

It is yet another object of the present invention to provide a qualitative sleep data analytics platform and application tool both online and offline.

In an aspect of the present invention is disclosed an apparatus for detecting and providing treatment sleep disordered breathing comprising a means for placing head of a user comprising an outer portion having a head portion and a neck portion and an inner portion comprising a processing unit operably configured to a transceiver; a detecting unit comprising plurality of sensors to detect snoring or obstructive upper airflow in the upper respiratory airway or breathing pauses of a person and is communicatively coupled to the transceiver; wherein the said means for placing the head comprises an active mechanism, at the inner portion, for adjusting the biomechanics of the person by an orthopedic non- implant/non-invasive body apparatus to stop the obstructive upper airflow or breathing pauses or snoring of the person to restore normal breathing airflow without awakening the person from sleep, wherein the active mechanism is activated by the processing unit, upon receiving, by the transceiver, signals of disordered breathing from the detecting unit for more than a threshold unit of time.

In another aspect of the present invention is disclosed a method of rectifying sleeping disorder by an apparatus having a means for placing the head wherein the method comprises detecting, by a detecting unit, an obstructive upper airflow in the upper respiratory airway or breathing pauses of a person sleeping; communicating the detected signal, by the detecting unit, to a processing unit; activating, by the processing unit, an active mechanism of the means for placing the head, if an obstructive upper airflow in the upper respiratory airway or breathing pauses is detected for a threshold unit of time; and adjusting, by the active mechanism, biomechanics of the person by an orthopedic non- implant/non-invasive body apparatus to stop the obstructive upper airflow or breathing pauses of the person to restore normal breathing airflow without awakening the person from sleep.

The foregoing and additional features and advantages of the invention will be more readily apparent from the following detailed description, which is provided with reference to the accompanying drawings.

BRIEF DESCRIPTION OF THE ACCOMPNAYNG DRAWINGS

The above and other aspects, features, and advantages of certain exemplary embodiments of the present invention will be more apparent from the following description taken in conjunction with the accompanying drawings in which:

Figure 1 illustrates the different paths of airflow in the respiratory tract of a person during different conditions, in accordance with the background art of the present invention.

Figure 2 illustrates a schematic diagram an apparatus for detecting and providing rectification of sleep disordered breathing, in accordance with one embodiment of the present invention.

Figure 3 illustrates a block diagram the apparatus, in accordance with one embodiment of the present invention.

Figure 4 illustrates a cross-sectional view of chamber compartment of an active mechanism comprising an Electro-Mechanical Angular Active Mechanism (EMAAM) and Gear Integration Turning Assemble (GITA), in accordance with one embodiment of the present invention. Figure 5 illustrates a top cross-sectional view of the motion bio-sensors and tactile movements’ mechanism and sounds detection mechanism, in accordance with one embodiment of the present invention.

Figure 6 illustrates an exemplary scenario of the user of the herein disclosed pillow and another user of a normal pillow (user’s partner, who is a non-user of the disclosed invention), in accordance with one embodiment of the present invention.

Figures 7A, 7B, and 7C illustrate a cross-section view of the head-Neck movements Left/Right side rotation by the active mechanism, in accordance with one embodiment of the present invention.

Figure 8 illustrates a top view of the head-neck adjustment biomechanically with down slope wedge extension to support the upper back to provide muscle relaxation during sleep, in accordance with one embodiment of the present invention.

Figure 9 illustrates the pillow communicatively coupled to an electronic device, in accordance with one embodiment of the present invention.

Figure 10 illustrates a screenshot showing data analytics platform, in accordance with one embodiment of the present invention.

Persons skilled in the art will appreciate that elements in the figures are illustrated for simplicity and clarity and may have not been drawn to scale. For example, the dimensions of some of the elements in the figure may be exaggerated relative to other elements to help to improve understanding of various exemplary embodiments of the present disclosure. Throughout the drawings, it should be noted that like reference numbers are used to depict the same or similar elements, features, and structures. DETAILED DESCRIPTION OF THE INVENTION

The following description with reference to the accompanying drawings is provided to assist in a comprehensive understanding of exemplary embodiments of the invention. It includes various specific details to assist in that understanding but these are to be regarded as merely exemplary.

Accordingly, the persons skilled in the art will recognize that various changes and modifications of the embodiments described herein can be made without departing from the scope of the invention. In addition, descriptions of well-known functions and constructions are omitted for clarity and conciseness.

The terms and words used in the following description are not limited to the bibliographical meanings, but, are merely used by the inventor to enable a clear and consistent understanding of the invention. Accordingly, it should be apparent to those skilled in the art that the following description of exemplary embodiments of the present invention are provided for illustration purpose only and not for the purpose of limiting the invention as defined by their equivalents.

It is to be understood that the singular forms“a”,“an,” and“the” include plural referents unless the context clearly dictates otherwise.

By the term“substantially” wherever used or will be used later it is meant that the recited characteristic, parameter, or value need not be achieved exactly, but that deviations or variations, including for example, tolerances, measurement error, measurement accuracy limitations and other factors known to those of skill in the art, may occur in amounts that do not preclude the effect the characteristic was intended to provide.

Features that are described and/or illustrated with respect to one embodiment may be used in the same way or in a similar way in one or more other embodiments and/or in combination with or instead of the features of the other embodiments. It should be emphasized that the term“comprises/comprising” when used in this specification is taken to specify the presence of stated features, integers, steps or components but does not preclude the presence or addition of one or more other features, integers, steps, components or groups thereof.

The present invention discloses an apparatus and a method for detecting and providing therapeutic treatment for sleep disordered breathing. The apparatus comprises a means for placing the head, of the person sleeping, comprising a head portion and a neck portion. The said means for placing the head is and not limited to a pillow. The pillow is provided a motion bio-sensor and an active mechanism comprising an Electro- Mechanical Angular Active Mechanism (EMAAM) and Gear Integration Turning Assemble (GITA). Further, the apparatus comprises an Infrared sensor or camera, a tactile mechanism and sound sensors. The IR sensor or camera is used to detect the body or head positions during sleeping time of the Pillow and the sound sensors are used to detect the snoring or obstructive upper airflow or breathing pauses in any sleep position. Upon detecting the movements and sound, the pillow activates the active mechanism to adjust head-neck movements Left/Right side rotation for managing to restore normal breathing airflow (pharynx) without waking from sleep. Further, the apparatus is communicatively coupled to an electronic device and/or a server to derive qualitative sleep analytics data report indicating an Apnea / Hypopnea Index (AHI) score and the severity of sleep apnea to provide the effectiveness of treatment for the clinical evolution and compliances. The apparatus is capable to identify sounds definition or characteristics that includes snore sound versus non-snore sounds (breathing, coughing, somniloquy or sleep-talking, sleeping partner breathing, environmental noises). It is also capable of analyzing sound characteristics which comprises power spectrum method to provide AHI score for snorer (AHI < 1) or obstructive sleep apnea (AHI >= 1)

The various embodiments of an apparatus and a method for detecting and providing the rectification for sleep disordered breathing are explained with the help of figures 2-10. Referring to figures 2 and 3, a schematic diagram and a block diagram of an apparatus (100) for detecting and rectifying sleep disordered breathing is shown, respectively, in accordance with one embodiment of the present disclosure. The apparatus (100) comprises a pillow (110). The apparatus further comprises a detecting unit mainly comprises plurality of sensors. It includes at least one Infrared (IR) Sensor or a camera (160), plurality of sound sensors (165 A, 165B), at least one vibration sensor (145), at least one motion bio-sensor (150), and a tactile mechanism (158). At an outer portion, the pillow (110) comprises a head portion (115) and a neck portion (120). As can be seen in figure 2, the head portion (115) is lowered compared to the neck portion (120). As such, when a user lies down on the pillow (110), the user can position his head at the head portion (115) and neck at the neck portion (120).

Further, at the inner portion, the pillow (110) may comprise a processing unit (125), a memory (130), an interface (135), a transceiver (140), at least one vibration sensor (145), at least one motion bio-sensor (150) and an Active mechanism (155) comprising an Electro-Mechanical Angular Active Mechanism and a Gear Integration Turning Assemble (GITA). Further, the pillow (110) may comprise a tactile mechanism (158). Furthermore, the pillow (110) may comprise a sound sensor (165B).

The processing unit (125) may be implemented as a processor, one or more microprocessors, microcomputers, microcontrollers, digital signal processors, central processing units, state machines, logic circuitries, and/or any devices that manipulate signals based on operational instructions. Among other capabilities, the processing unit (125) is configured to fetch and execute computer-readable instructions stored in the memory (130). In the embodiments explained herein below, the processing unit is regarded as the processor (125) by way of exemplary embodiment of the invention and not by way of limiting the scope of the invention.

The memory (130) may include any computer-readable medium known in the art including, for example, volatile memory, such as static random access memory (SRAM) and dynamic random access memory (DRAM), and/or non-volatile memory, such as read only memory (ROM), erasable programmable ROM, flash memories, hard disks, and so on, but are not limited to the said examples.

The interface (135) may include a variety of software and hardware interfaces, for example, a web interface, a graphical user interface, and the like. The interface (135) may allow the pillow (110) to communicate with other computing devices, such as web servers and external data servers-cloud application and data analytics platform (not shown). In one example, the interface (135) may include one or more ports for connecting a number of devices to one another or to another server.

The detecting unit of the apparatus includes an active layer having an (inertial) motion bio-sensors network in an arrangement. The arrangement may be in the ID array or 2D matrix. The matrix may be having 3 rows x 5 columns or 3 rows x 3 columns or 5 rows x 5 columns. The arrangement of 2D matrix includes adjacent elements for controlling the head movements and either left or right side of rotation and a support section. Bio-motion sensors may be arranged in different ways. An arrangement of bio motion sensors may be Quadrilateral arrangements, triangle on the right side and triangle on the left side or any other possible combinations of arrangement. The tactile head-neck movements are detected with active and passive layer of motion bio-sensors mechanisms.

The transceiver (140) may be used to send or receive data or information from the pillow (110) to other devices or server.

The at least one vibration sensor (145) may indicate a sensor used for detecting vibrations in the pillow (110). It should be understood that the at least one vibration sensor (145) is communicatively coupled to the processor (125).

The at least one motion bio-sensor (150) may indicate a sensor used for detecting motion in the pillow (110). It should be understood that the at least one motion bio-sensor (150) is communicatively coupled to the processor (125). The at least one tactile mechanism (158) is for detecting the head-neck movements and monitoring movements internally or externally. It should be understood that the at least one tactile mechanism (158) is communicatively coupled to the processor (125).

The active mechanism (155) comprising the Electro-Mechanical Angular Active Mechanism (EMAAM) and Gear Integration Turning Assemble (GITA) may indicate a mechanical arrangement for adjusting the biomechanics of head portion (115) and the neck position (120) and cervical spinal alignment by orthopedic non-implant body apparatus. The said assemble includes electronics components that help to rotate the gear parts. The gear parts are configured for turning (left or right as desired), lifting (up or down) and so on. The said assemble includes electronics parts to serve this purpose as would be known to a person skilled in the art. Referring to figure 4, a cross-section view of chamber compartment of the active mechanism (155) is shown.

Further, figure 5 shows a top cross-sectional view of the motion bio-sensors and tactile movements’ mechanism and sounds detection mechanism.

Further, the apparatus (100) comprises at least one Infrared (IR) Sensor or camera (160) and a sound sensor (165A). Each of the IR sensor (160) and the sound sensor (165A) are provided external to the pillow (110). For instance, the IR sensors (160) and the sound sensor (165A) placed externally may be installed at side and rear of a bed on which the pillow (110) is placed. Further, the sound sensor (165A) may be placed close to the IR sensor (160) or proximity to the pillow (110).

It should be understood that the IR sensors (160) and the sound sensor (165A) externally placed may be used to detect movement of a user when resting head on the pillow (110). Further, the externally placed sound sensor (165A) may be used to detect sounds such as snoring made by the user while resting on the pillow (110).

In order to detect sleep disorder of a user lying on the pillow (110), the vibration sensor (145), the bio-motion sensors (150), the IR sensors (160), the sound sensors (165A and 165B) and the tactile mechanism (158) are used. Specifically, the sounds sensors (165B) inbuilt within apparatus (100) are placed nearby the pillow (110) to record sound i.e., to detect the snoring or obstructive upper airflow or breathing pauses in any sleep position. Further, the IR sensors (160) detect the body or head positions during sleeping time of users of the pillow (110) user and non-therapeutic Pillow (user’s partner). An example scenario of the therapeutic Pillow (110) user and non- therapeutic Pillow (user’s partner) is depicted in figure 6.

The method of rectifying sleeping disorder by the said apparatus comprises detecting, by the detecting unit, an obstructive upper airflow in the upper respiratory airway or breathing pauses of a person sleeping, followed by communicating the detected data, by the detecting unit, to the processing unit (125). Further, the method includes adjusting, by the active mechanism, biomechanics of the person by orthopedic non- implant/non-invasive body apparatus to stop the obstructive upper airflow or breathing pauses of the person to restore normal breathing airflow without awakening the person from sleep, if an obstructive upper airflow in the upper respiratory airway or breathing pauses is detected.

After detecting that the user is snoring or moving during his sleep, the vibration sensor (145), the bio-motion sensors (150), the IR sensors (160), the sound sensors (165A and 165B), and the tactile mechanism (158) may send signals to the processor (125). It should be understood that the apneas (pauses in breathing) should last for at least 10 seconds or longer, which is the same time of pillow user to send the signals to the processor (125). Thus, the threshold unit of time for the detecting unit to send signal of detection of disordered breathing is 10 seconds. This is clinically identified threshold time to identify sleep disorders. Upon receiving signals indicating that the user is sleep deprived or has sleeping disorder, then the processor (125) may employ the EMAAM (155). Specifically, the processor (125) activates the EMAAM (155) in order to adjust head-neck movements Left/Right side rotation for managing to restore normal breathing airflow (pharynx) without waking from sleep. Within the apparatus, positional Sleep Apnea can be detected to provide positional therapy. The detection is done by tracking the body physical characteristics movements of the user in sleep in supine or non-supine or lateral sleeping position or position in starfish or sleeping on stomach position.

Referring to figures 7A, 7B, and 7C, a cross-section view of the head-Neck movements Left/Right side rotation by the active mechanism i.e., EMAAM (155) for managing to restore normal breathing airflow (pharynx) without waking from sleep are shown. It should be understood that the EMAAM (155) is operated for head-neck adjustment biomechanically with down slope wedge extension to support the upper back to provide muscle relaxation during sleep. In one example, the EMAAM (155) may comprise at least two chambers i.e., a fabric or textile material comprising, two chambers or portion of the active mechanism i.e., EMAAM (155) wherein fixing the EMAAM (155) midway in between the side edges in middle active layer of the two passive layers (Top layer and bottom layer) as shown in figures 7A, 7B, and 7C. Figure 7A shows a position of the head of the person with the EMAAM in the middle active layer and the GITA at the side edges. The EMAAM and GITA are configured to provide therapeutic treatment upon detection of snoring or obstructive upper airflow or breathing pauses in any sleep positions of the body of sleeping in the sleeping individual. Figure 7B shows the head of the individual being tilted towards the left upon detection of abnormalities while figure 7C shows the head of the individual being tilted towards the right, when sleep related abnormalities are detected.

The processor (125) assists the Active mechanism (EMAAM) or Gear Integration Turning Assemble (GITA) to identify which side (either left or right) of the body of the sleeping person requires adjustment. This advantageously restores the breathing back to normal.

Now, referring to figure 8, a top view of the embodiment of the head-neck adjustment biomechanically with down slope wedge extension to support the upper back to provide muscle relaxation during sleep is shown. When activated, EMAAM (155), the tactile mechanism (158), the motion bio-sensor (150) adjust head and cervical neck position to restore the normal airway in upper respiratory airway until the disorder stops during sleep. Further, the processor (125) continuously checks with the IR sensors (160) and the sound sensor (165) for movements and snoring sound. Upon detecting that the body or head movement have stopped and snoring has stopped, the processor (125) may instruct the EMAAM (155) and the motion bio-sensor (150) to deactivate. The method of rectifying the sleep disorder is repeated whenever the IR sensors (160) and the sound sensor (165) and the tactile mechanism (158) detect movements and snoring sound.

In one implementation, the pillow (110) is communicatively coupled to an electronic device (200) of the user, as shown in figure 9. The electronic device (200) may include but not limited to a mobile phone, a tablet, a smart watch, a desktop computer, cloud application and data analytics platform and so on. Further, the pillow (110) may be communicatively coupled to a server-cloud application and data analytics platform (not shown). The pillow (110) is coupled to the electronic device (200) or the server for sharing that data processed by the processor (125). Specifically, the data is shared for performing data analytics on the sleep patterns of the user and reporting AHI index score.

In an embodiment, the detection of sound disordered breathing by the sound sensor (165B) for a pre-set time and for predetermined physical characteristics can be used to identify a pattern event using Artificial intelligence (AI) / Machine Learning (ML) data analytics to consequently activate bio-sensors (150). Further, the sleep positions of the user can be tracked to activate the active mechanism when predetermined physical characteristics of identified patterns result in detected on-going and/or up coming events during the course of sleep of the person. The apparatus is configured to restore breathing or airflow in pharynx (or upper airway respiratory track) of the user and at the same time it is done by adjusting the position of head and neck without waking from sleep. The said restoration of breather and adjustment is done if at least one of the body physical characteristics is detected for a pre-set time and the predetermined physical characteristics of the identified pattern specific to user having events. Artificial intelligence (AI) / Machine Learning (ML) data analytics are used to activate EMAAM. The apparatus can further track the sleep position of the user to activate the mechanism when a predetermined physical characteristic of the identified pattern of events is detected as an on-going and/or as an up-coming event during sleep of the individual.

In an embodiment of the invention, the Active mechanism (EMAAM) or Gear Integration Turning Assemble (GITA) are activated to orient the user to an identified side which is either left or right of the body. The identified side for restoring the breathing in the user is based on body physical characteristics. The desired orientation of the user is brought by tilting the head and neck. Tilting operation includes setting an inclination angle or slope to the horizontal axis on the opposite side of the head position or movement. The said inclination angle is within the range of 0 degree to a maximum of 90 degree.

To derive qualitative sleep analytics data report indicating the Apnea / Hypopnea Index (AHI) score and the severity of sleep apnea that provided the effectiveness of treatment for the clinical evolution and compliances.

An example of a screenshot showing data analytics platform to monitor snoring or apnea events episodes and head movements for sleep-disorders that to provide the effectiveness of treatment for the clinical evolution and compliances is depicted in figure 10

The data is analyzed for assessment and prediction trend Sleep Report to provide objective assessment of treatment, determine the effectiveness (is not influenced by a doctor’s bias or user feedback or user’s partner inputs as followed by evaluation using ESS score or Berlin questionnaire (BQ) in clinical settings).

Based on the above, the present disclosure facilitates in reducing the snoring and managing AHI index of OSA syndrome to indicate the severity of sleep apnea. Based on the AHI, the severity of OSA is classified as follows:

1. None/Minimal: AHI < 5 per hour,

2. Mild: AHI > 5, but < 15 per hour, 3. Moderate: AHI > 15, but < 30 per hour,

4. Severe: AHI > 30 per hour.

It should be understood that shape of the therapeutic pillow is not restricted to specific area of Head or neck or cervical. The pillow should detect the snoring or obstructive respiratory events and manage the OSA AHI index or reducing snoring level as per the gold-standard treatment/therapy for sleep disordered breathing.

Based on the above, it is evident that the present disclosure is used for detecting and therapeutic treatment of sleep-disordered breathing in the upper respiratory airway. The therapeutic orthopedic sleeping pillow is utilizing in combination with detecting mechanism of loud snoring or obstruction upper airflow in the pharynx and restoring normal breathing without waking up during sleep in the supine position or non-supine position.

Whenever, the apparatus comprising therapeutic pillow detects snoring and obstructive upper airflow or breathing pauses and tactile mechanism for head-neck movements, then the apparatus activates the active mechanism to restore breathing airflow without awakening from sleep. Further the qualitative sleep data analytics and database storage (online/offline) platform on a mobile device or computer system and - cloud application and data analytics platform that provides the effectiveness of treatment for the sleep-disordered.

Within the apparatus, a head and cervical (neck) support, in particular anatomically contorted shaped orthopedic apparatus to provide muscle relaxation during sleep of the individual. The upper side slope of downhill curve shape for head positioning wherein biomechanical head (height adjustment or maintain) support surface. The said downhill curve shape angle is having a curvature of 10 degrees to a maximum of 60 degrees. This is not a limiting range. The lower curve shape has an angle of inclination within the apparatus in the middle part to support the cervical upper back support wherein hyper-extension of the neck to keep open airway during sleep. The said angle of inclination of the lower curve shape is in the range 80 degrees to a 120 degrees but it is not limited to this range.

Bed-side or wall mounted apparatus that can be or connected to the body surface to monitor the oxygenation level either wearable or non-wearable device and taking the body-position to give feedback to an active mechanism. The Blood oxygen levels are recorded and monitoring during sleep. At sea level, a normal blood oxygen level (saturation) is usually 96 - 97% that is accepted as per clinical classifications in sleep medicine for severity of oxygen de- saturation, reductions to not less than 90% - considered mild. Further dips into the 80 - 89% range -considered moderate, and those below 80% are considered severe.

The health benefits with the disclosed pillow apparatus for sleep disordered breathing and the parameter compliances achieved by way of the herein disclosed solution are same as gold-standard (i.e. AHI should be < 5 per hour or None). It is an alternative solution that helps in improvement in health conditions that includes solutions to:

• cardiovascular problems,

• Atrial fibrillation (irregular heartbeat),

• Coronary artery disease,

• Regulates blood pressure both during daytime and night,

• Reduce the risk of stroke,

• Management of type 2 diabetes,

• Obesity

The apparatus is configured to identify and distinguish the sounds of the user using herein disclosed pillow and user of other pillows (user’s partner, who is a non-user) and activates electro-mechanical mechanism to prevent sleeping disorder breathing in the upper respiratory airway of the user using the herein disclosed apparatus. The electro mechanical mechanism does not activate by detecting user’s partner (non-user) sounds. The foregoing description conveys the best understanding of the objectives and advantages of the present invention. Different embodiments may be made of the inventive concept of this invention. It is to be understood that all matter disclosed herein is to be interpreted merely as illustrative, and not in a limiting sense.

Claims

1. An apparatus for detecting and providing treatment for sleep disorder comprising: a means for placing head of a user (110) comprising an outer portion having a head portion (115) and a neck portion (120), and an inner portion comprising a processing unit (125) operably configured to a transceiver (140);

a detecting unit comprising plurality of sensors to detect snoring or obstructive upper airflow in the upper respiratory airway or breathing pauses of a person and is communicatively coupled to the transceiver (140); wherein

the said means for placing the head (110) comprises an active mechanism, at the inner portion, for adjusting the biomechanics of the person by an orthopedic non-implant/non- invasive body apparatus to stop the obstructive upper airflow or breathing pauses or snoring of the person to restore normal breathing airflow without awakening the person from sleep, wherein the active mechanism is activated by the processing unit (125), upon receiving, by the transceiver (140), signals of disordered breathing from the detecting unit for more than a threshold unit of time.

2. The apparatus as claimed in claim 1, wherein the threshold unit of time is 10 seconds.

3. The apparatus as claimed in claim 1, wherein the processing unit (125) is configured to identify the acoustics of snoring or obstructive sleep apnea or upper airflow or breathing pauses or vibration sounds of an anatomical structure in the upper pharyngeal airway of the user; and wherein the processing unit (125) is configured to distinguish the snore sound from non-snore sounds and further configured to analyse the sound characteristics.

4. The apparatus as claimed in claim 1, wherein the processing unit (125) is configured to analyze the sound characteristics by power spectrum method to obtain an Apnea- hypopnea Index (AHI) score for the user, wherein the AHI score is less than 1 for a snorer and AHI score is more than or equal to 1 for obstructive sleep apnea. 5. The apparatus as claimed in claim 1, wherein the active mechanism is a mechanical arrangement comprising an Electro-Mechanical Angular Active Mechanism, EMAAM, (155) and Gear Integration Turning Assemble, GITA, operably coupled to each other to adjust the biomechanics of the person by adjusting the head portion (115), neck portion (120) and the cervical spinal alignment of the person.

6. The apparatus as claimed in claim 5, wherein the EMAAM (155) is operated for head- neck adjustment biomechanically with down slope wedge extension to support the upper back to provide muscle relaxation when the person is sleeping.

7. The apparatus as claimed in claim 5, wherein the active mechanism is a fabric or textile material comprising, two chambers on left side and right side of the means for placing the head wherein a tilting control chamber having the EMAAM (155) or the GITA is fixed midway wherein the said chamber is in between the side edges in a middle active layer of two passive layers.

8. The apparatus as claimed in claim 7, wherein the EMAAM comprises an active layer of motion bio-sensors and a passive layer of motion bio-sensors configured to detect the tactile head-neck movements.

9. The device as claimed in claim 5, wherein the EMAAM and the GITA are configured to restore breathing airflow in the upper airway respiratory track and adjust the position of head and neck without waking the user from sleep simultaneously.

10. The device as claimed in claim 1, wherein the processing unit (125) is configured to track the body physical characteristics of the user for a pre-set time and identify a pattern in the characteristics; and determining a pre-determined physical characteristics specific to the user from the identified pattern, wherein a pre-determined physical characteristics specific to the user is determined using Artificial intelligence (AI) and Machine Learning (ML) data analytics to the plurality of sensors (150).

11. The device as claimed in claim 10, wherein the physical characteristics is the plurality of sleep positions of the user, wherein the device is further configured to activate the EMAAM, when the processing unit detects the predetermined physical characteristics of identified patterns and the processing unit (125) is configured to detect on-going and/or up-coming physical characteristics from the identified pattern of the user during sleep of the individual.

12. The device as claimed in claim 11, wherein the EMAAM and the GITA are configured to tilt the body of the user to a determined orientation of the body based on the up-coming or on-going event; wherein the body is tilted corresponding to an angle of inclination, wherein the said angle of inclination is in the range between 0 degree to a maximum 90 degree to the horizontal axis on the opposite side of the head position or movement.

13. The device as claimed in claim 1, wherein the device is configured to operate in continued feedback loop to restore normal breathing airflow without awakening the user from sleep based on predetermined physical characteristics of sleep-disordered.

14. The device as claimed in claim 10, wherein apparatus is configured to detect positional sleep Apnea by tracking the body physical characteristics movements in supine or non-supine or lateral sleeping position or starfish sleeping position or sleeping on stomach position of the user; wherein when positional sleep Apnea is detected the device is configured to correct the position of the user.

15. The apparatus as claimed in claim 1, wherein the orthopedic apparatus is a head and cervical support having anatomically contorted shaped to provide muscle relaxation when the person is sleeping.

16. The apparatus as claimed in claim 15, wherein the apparatus comprises an upper side slope of downhill curve shape with an angle of curve for head positioning and a biomechanical head support surface.

17. The apparatus as claimed in claim 15, wherein the apparatus further comprises a lower curve shape having an angle of inclination within the apparatus in the middle part to support the cervical upper back and the hyper-extension of the neck to keep open the airway of the person.

18. The apparatus as claimed in claim 1, wherein detecting unit comprises at least one Infrared (IR) Sensor or a camera (160), plurality of sound sensors (165A, 165B), at least one vibration sensor (145), at least one motion bio-sensor (150), and a tactile mechanism (158); wherein the detecting unit is configured to obtain information about sleep positions of the user, sound produced during the sleep and movement of the user.

19. The device as claimed in claim 1, wherein the detecting unit comprises an active layer of at least network of motion bio-sensors arranged in an arrangement of 1-D array or 2-D array of bio-sensors placed as adjacent elements configured to control the head movements and

a support section.

20. The device as claimed in claim 19, wherein the arrangements include Quadrilateral arrangements, triangle on right side and/or left side or other possible combinations arrangements.

21. The apparatus as claimed in claim 18, wherein the at least one IR sensor (160) for detecting movement of the user when the user is resting head on the means for placing the head (110) and at least one sound sensor (165A) for detecting breathing sounds are adapted to be placed external to the means for placing the head (110).

22. The apparatus as claimed in claim 18, wherein the at least one vibration sensor (145) for detecting vibrations in the means for placing the head (110), the at least one motion bio-sensor (150) for detecting motion in the means for placing the head (110) and the at least one tactile mechanism (158) for detecting the head-neck movements by monitoring the movements internally or externally are provided at the inner portion of the means for placing the head (110). 23. The apparatus as claimed in claim 1, wherein the head portion (115) is comparatively lower to the neck portion (120) such that when the person lies down on the means for placing the head (110), the person can position the head at the head portion (115) and neck at the neck portion (120).

24. The apparatus as claimed in claim 1, wherein the detecting unit detects the obstructive upper airflow or breathing pauses in any sleep positions of the body of the sleeping person.

25. The apparatus as claimed in claim 1, wherein the means for placing the head (110) is communicatively coupled to an electronic device (200) of the person, wherein the electronic device (200) is a mobile phone, a tablet, a smart watch, a desktop computer, a cloud application and/or a data analytics platform.

26. The apparatus as claimed in claim 25, wherein the apparatus is communicatively coupled to a server-cloud application and a data analytics platform for performing data analytics on the sleep patterns of the person and for reporting AHI index score.

27. The apparatus as claimed in claim 1, wherein the means for placing the head (110) comprises an interface (135) to communicate with other computing devices.

28. A method of rectifying sleeping disorder by an apparatus (100) having a means for placing the head (110), wherein the method comprises:

detecting, by a detecting unit, an obstructive upper airflow in the upper respiratory airway or breathing pauses of a person sleeping;

communicating the detected signal, by the detecting unit, to a processing unit

(125);

activating, by the processing unit, an active mechanism of the means for placing the head (110), if an obstructive upper airflow in the upper respiratory airway or breathing pauses is detected for a threshold unit of time; and adjusting, by the active mechanism, biomechanics of the person by an orthopedic non-implant/non-invasive body apparatus to stop the obstructive upper airflow or breathing pauses of the person to restore normal breathing airflow without awakening the person from sleep.

29. The method as claimed in claim 28, wherein detecting unit comprises at least one Infrared (IR) Sensor or a camera (160), plurality of sound sensors (165A, 165B), at least one vibration sensor (145), at least one motion bio-sensor (150), and a tactile mechanism (158).

30. The method as claimed in claim 28, wherein the processing unit (125) continuously checks with the IR sensors (160) and the sound sensors (165) for movements and undesired sounds, and the processing unit (125) deactivates EMAAM (155) and the motion bio-sensor (150), upon detecting that the body or head movements and the undesired sounds have stopped.

31. The method as claimed in claim 28, wherein the steps are repeated whenever the IR sensors (160), the sound sensor (165) and the tactile mechanism (158) detect movements and/or undesired sounds.

32. The method as claimed in claim 28, wherein the threshold unit of time is 10 seconds.