WO2009149375A1

WO2009149375A1 - Headgear device and methods thereto

Info

Publication number: WO2009149375A1
Application number: PCT/US2009/046448
Authority: WO
Inventors: Bret F. Randall
Original assignee: Randall Bret F
Priority date: 2008-06-05
Filing date: 2009-06-05
Publication date: 2009-12-10

Abstract

This disclosure concerns headgear devices useful generally in allowing the comfortable engagement of external apparatuses to the head or face of a human subject, and methods thereto. More specifically, devices according to the present disclosure may be used by subjects treated by continuous positive airway pressure during sleep.

Description

HEADGEAR DEVICE AND METHODS THERETO

PRIORITY CLAIM This application claims the benefit of the filing date of United States Provisional Patent Application Serial Number 61/059,167, filed June 5, 2008, for "HEADGEAR DEVICE AND METHODS THERETO".

TECHNICAL FIELD The present disclosure relates primarily to the field of external devices fitted to the head of a human subj ect.

BACKGROUND

Sleep apnea is a serious breathing disorder characterized by repeated sequences of snoring, breathing difficulty, lack of breathing, waking enough to resume breathing and returning to sleep. Often, the sufferer is not consciously aware of the sleep disorder. Individuals suffering from sleep apnea usually experience symptoms characteristic of sleep deprivation, such as severe drowsiness, irritability, functional and mental limitations, etc. Sleep apnea sufferers are also at greater risk to develop hypertension, heart attack, and stroke. In addition, untreated sleep apnea may be responsible for poor performance in everyday activities, such as at work and school, motor vehicle crashes, as well as academic underachievement in children and adolescents. The most common form of sleep apnea is obstructive sleep apnea (OSA). OSA is a potentially fatal sleep disorder that affects an estimated 5% of the population in which muscles which normally hold the airway open during sleep relax and ultimately collapse, sealing the airway. Less common central sleep apnea (CSA) results when the central nervous system fails to initiate respiratory muscle activity. Mixed sleep apnea (MSA) is characterized by a combination ofCSA and OSA.

Continuous Positive Airway Pressure (CPAP) treatment is a common ameliorative treatment for breathing disorders including OSA. CPAP has also been shown to be an effective treatment, for example, of patients suffering from Alzheimer's Disease with a sleep-related breathing disorder. (American Academy of Sleep Medicine (2007, June 13), CPAP Improves Sleep In Patients With Alzheimer's Disease, Sleep-related Breathing Disorder, ScienceDaily, sciencedaily.com- /releases/2007/06/070611074214.htm). CPAP decreases daytime sleepiness and lowers blood pressure during both the day and the night. Additionally, people with coronary artery disease who use CPAP for sleep apnea are less likely to have heart problems such as heart failure. Sleeping partners of individuals treated with CPAP may also enjoy improved sleep, at least in part due to control of the treated individual's breathing volume and restlessness-related motor activity.

CPAP may be used nightly, during sleep. CPAP therapy increases air pressure in the throat of the subject, so that the subject's airway does not collapse when the subject inhales. The preferred CPAP apparatuses in common use presently comprise a mask covering the nose (Nasal Continuous Positive Airway Pressure: NCPAP); examples of alternative devices include those with breathing tubes inserted directly into the nasal passage, and full-face masks that cover the nose and mouth.

DISCLOSURE OF INVENTION Embodiments include devices for use in the treatment of sleep apnea, and more particularly, OSA. It is understood that these embodiments are illustrative, and in no way limit the scope of the invention. These or other embodiments may be used in the treatment of other breathing disorders, in the comfortable attachment of external devices in a fixed position to the face or mouth of a human subject during sleep, in the delivery of assisted respiration to an adult or a neonate, in the attachment of orthodontic hardware to the face or mouth of a human subject, or in any context where a comfortable means of attaching an external device in a fixed position to the face of a subject is desired. These or other embodiments may also be used to provide additional comfort or more restful sleep, either for the subject wearing a device according to these or other embodiments, or for other humans near enough to the subject to be affected by restlessness of the subject. Additional features and elements may be added to, or subtracted from, disclosed embodiments as understood by those of ordinary skill in the art.

Embodiments include a device for receiving a human head comprising: at least one means for adjustably fitting the device to the human head, a chin portion capable of engaging a human chin, and a portion capable of engaging a continuous positive airway pressure system (CPAP) in an operative position on the head. In embodiments, the tension holding the device against the head may be distributed essentially evenly across the top and/or back of the head. In further embodiments, the tension is distributed over a wide surface area so that in any given location, the force is small. In embodiments, the chin portion may bias the lips of the wearer toward a closed position. Also, in embodiments, the chin portion of the device may be detachable from the remainder of the headgear device. In further embodiments, a device may further comprise one or more cushions between the head of the wearer and the chin portion of the device. In other embodiments, a device may comprise one or more cushions that may dampen the passage of external sound to the ear. In other embodiments, a device may conform itself to fit the human head when the head is received within the device. And, in additional embodiments, a device may be adjusted by an individual to conform to the specific dimensions of the head of the wearer. In further embodiments, a device may comprise an opening in a portion contacting the back of the head. Embodiments of the device may be manufactured from a stiff material. In some embodiments, said stiff material may be selected from a group comprising cotton, leather, and/or natural fibers. Embodiments may be machine washable. Embodiments may not necessarily comprise a CPAP interface, and may be worn independently of a CPAP interface.

Further embodiments include a device for receiving the head of a human comprising: a first end that engages the top of the head, a second end that engages the chin of a wearer, and a surface defining a space in which may be received the face and mouth of a wearer, wherein a continuous positive airway pressure system (CPAP) may be engaged with a wearer's head when the head is received within the device. An embodiment may be of unitary construction, such as, by way of example, a one-piece fabric tube. In embodiments, the second end that engages the chin may bias the lips of a wearer toward a closed position. In embodiments, a device may comprise one or more cushions retained in a position between the one-piece fabric tube and the head. In embodiments, a device may comprise one or more elements capable of retaining a CPAP interface in contact with the wearer's head in an operative position. In further embodiments, a device may comprise a means for attaching tubing from a positive airway pressure system in a fixed position to the front or top of a head. In one embodiment, a method for treating a breathing disorder in a human subject is disclosed. A method may comprise receiving the head of a wearer in a device, wherein the device may comprise one or more means for adjustably fitting the device to the head, and wherein the device may be capable of securely holding a continuous positive airway pressure apparatus in an operative position when the head is received within the device. In embodiments, a breathing disorder treated by a disclosed method may be obstructive sleep apnea. In some embodiments, a method may further comprise allowing a human subject to sleep. In some embodiments, a method may further comprise treating a human subject with a continuous positive airway pressure system (CPAP). In some embodiments, a method may further comprise adjustment of a device to conform to the specific dimensions of the head of a human subject. In some embodiments, a method may further comprise maintaining a seal between a continuous positive airway pressure system and the head of a human subject. In further embodiments, a neck pillow or neck brace may be provided to a human subject.

The foregoing and other features will become more apparent from the following detailed description of several embodiments, which proceeds with reference to the accompanying figures.

BRIEF DESCRIPTION OF DRAWINGS FIG. IA is an illustration of an embodiment of a headgear device comprising a single fabric tube, wherein the tension keeping the device in contact with the head is distributed essentially evenly across the top and back of the head and the chin. FIG. IB is an illustration of an embodiment of a headgear device of unitary construction, wherein the tension is distributed over a wide surface area.

FIG. 2 illustrates further embodiments of a headgear device useful, for example, in the treatment of a breathing disorder.

FIG. 2A is a right-side view of one such embodiment. FIG. 2B is a left-side view of the embodiment in 2 A.

FIG. 2C is a frontal view of an alternative further embodiment, wherein the chin strap portion is detachable from the remainder of the headgear device.

FIG. 3 is an illustration of a further embodiment of a headgear device useful, for example, in the treatment of a breathing disorder, wherein the head of a human subject is received within the embodiment at the same time the human subject is receiving continuous positive airway pressure treatment. FIG. 3A is a left-side view of the embodiment fitted to the head of a human engaged with a continuous positive airway pressure apparatus in the operative position.

FIG. 3 B is a left-side view of the embodiment fitted to the head of a human engaged with a continuous positive airway pressure apparatus in the operative position, wherein the continuous positive pressure apparatus is capable of being retained in the operative position.

FIG. 4 is a posterior view of a further embodiment of a headgear device useful, for example, in the treatment of a breathing disorder, wherein the headgear device is capable of being adjustably fitted to a human head. FIG. 4A depicts the embodiment placed on a human head in a first, unfitted position.

FIG. 4B depicts the embodiment fitted to a human head.

MODE(S) FOR CARRYING OUT THE INVENTION CPAP treatment is only effective if the subject of treatment wears the apparatus during sleep. CPAP apparatuses, and devices associated therewith, may cause, for example, acne or molding of the subject's hair into undesirable positions and are often not worn, or else removed, to avoid these undesirable results that may accompany CPAP treatment. Furthermore, several troublesome side-effects of CPAP therapy limit its usefulness as an ameliorative treatment. Patients treated with CPAP may experience nightmares and excessive dreaming during early use, dry nose, nosebleeds, sore throat, nasal congestion, runny nose, sneezing, irritation of the eyes and the skin on the face, abdominal bloating, headaches, and/or leaks around the mask. The primary causes of these side-effects are a poor fit between the device and the patient's head, discomfort from the device material, or a combination thereof. A CPAP apparatus may fail to provide a therapeutic benefit if the pressure seal between the CPAP apparatus interface and the face of the human subject is broken. Additionally, the effectiveness of CPAP using a nasal mask or nasal tubes is contingent upon the subject breathing exclusively through the nose. When a subject fitted with such a CPAP apparatus breathes through the mouth, the positive air pressure exerted by the device cannot act to prevent airway collapse.

To prevent subjects treated by CPAP from breathing through the mouth while the nasal CPAP apparatus is in use, a variety of techniques are employed to bias the subject's mouth to a closed position during sleep. Such techniques include chinstrap devices and neck pillows. These additional measures further encumber the subject with uncomfortable external hardware while the subject desires sleep, and makes it increasingly difficult for the subject to obtain a restful position. Moreover, combinations of devices that exist in the art hold the CPAP apparatus in place through tension that is exerted through one or more straps of discrete diameter. The area of the subjects' head beneath these straps experiences that focused tension during the entire time the devices are used. Periods of extended use, such as during sleep, lead to side effects of this focused tension, for example, acne, abrasions, rashes, and the destruction of desired hair designs. In many subjects, these undesired side effects cause the subject to discontinue use of the devices and/or the CPAP apparatus.

Embodiments include a single headgear device which comfortably accommodates a CPAP apparatus, which may simultaneously bias the subject's mouth towards a closed position, and may incorporate a minimal amount of uncomfortable external hardware. In various embodiments, the tension holding the device against the head of a human subject is distributed essentially evenly across the top and back of the head of a human subject. Such distribution may allow a more secure fit than traditional CPAP headgear devices, without the acne, rashes, bruising, or hair-shaping that often accompanies use of a traditional device with discrete straps. In further embodiments, points of attachment for a CPAP interface and/or a chin strap portion are widely distributed across the surface of a device. Such distributions may allow individual wearers to fit a device comfortably and securely according to their individual facial anatomy.

In order to facilitate review of the various embodiments of the disclosure, the following explanations of specific terms are provided: Continuous Positive Airway Pressure (CPAP) Apparatus: CPAP apparatuses are often used at home for the treatment of sleep apnea, but are also useful more generally in the treatment of patients suffering from respiratory failure and neonates. Typically, a CPAP apparatus includes a flow generator, a hose or tubing, and an interface. Common examples of CPAP interfaces include, but are not limited to, nasal or full face masks, nasal pillows, and lipseal mouthpieces. Embodiments of the present disclosure may be useful in combination with these and other interface designs. In some CPAP apparatuses, exhalation pressure relief is provided to reduce the positive airway pressure during exhalation, and reduce the effort required for breathing.

Operative Position: A CPAP apparatus is engaged with a human subject in an operative position if it is capable of providing positive pressure to the airway of said human subject. A CPAP apparatus is retained in an operative position if a human is not needed to hold the CPAP apparatus in place, for the CPAP interface to remain sealed to the face of the wearer, and for the apparatus to provide positive pressure to the airway of a human subject.

Securely Holding: A CPAP apparatus is securely held if it remains engaged in an operative position with a human subject through the body movements typically experienced by a sleeping individual.

Stiff Material: A device is constructed of a stiff material if the material possesses sufficient resilience to resist large changes in its surface area when exposed to a stretching force. A stiff material may be capable of distributing tension throughout the material. A stiff material may also be sufficiently flexible to allow changes in shape and configuration such that the material is suitable for use in a headgear fitted for individual use.

Tension is Distributed Essentially Evenly across the top and back of the head of a human subject if the subject does not perceive any particular loci where tension is concentrated against the head of the subject. Examples of devices wherein the tension is not essentially evenly distributed across the top and back of the head include those with isolated straps that bear the force of an attached object.

Tension is Distributed over a Wide Surface Area of a device if a large portion of the outer surface area of the device is able to compensate for and relieve increased tension applied to a different portion of the outer surface area of the device. A device that distributes tension over a wide surface area may have, by way of non-limiting example, one or more straps that may be 5.08, 6.35, 7.62, 8.89 or 10.16 cm wide.

Unitary Construction: A device is of unitary construction if the device comprises a single external surface. A device may be of unitary construction if it is manufactured from a single, continuous piece of material. Devices manufactured from several pieces of material may also be of unitary construction if they are stitched, glued, sewn, knitted, or otherwise attached together so as to make one continuous surface. EXAMPLES

The present disclosure proceeds by reference to the following examples, which are offered by way of illustration and are not intended to limit the invention in any manner. FIGs. 1-4 show several embodiments of a headgear device 100 useful, for example, in the treatment of a breathing disorder. In embodiments, tension 102 is distributed essentially evenly across the surface of the head 104 contained within the headgear device 100. In further embodiments, the tension 102 is distributed over a wide surface area so that in any given location, the force is small. The face 106, nose 108, and mouth 110 of a head 104 received within the headgear device 100 are exposed such that they can be engaged with any type of continuous positive airway pressure apparatus 300. In some embodiments, the device 100 is manufactured from a stiff material, such as cotton fabric. Devices 100 manufactured from a stiff material distribute tension essentially evenly through the device 100 when it is formed into a spherical shape on the head 104 of a human subject.

/. A headgear device capable of receiving a human head engaged with a continuous positive airway pressure apparatus in the operative position. Certain embodiments of a headgear device according to the disclosure may receive a human head while exposing the face, nose and mouth, such that the human may be treated with a CPAP apparatus, for example, during sleep. In further embodiments, the device is capable of exerting a force on the chin of the head such that the mouth of the head is biased towards a closed position while the human is treated with a CPAP apparatus. Often, devices designed to limit mouth breathing of a subject treated with a CPAP apparatus may be ineffective, because the subject may be able to release pressure through his/her closed mouth by movements of the subject's lips, even though the subject's mouth remains closed. Therefore, in further embodiments, the device according to the disclosure exerts a force on the lower lip flesh to bias the subject's lips toward a closed position. In still further embodiments, the device comprises one or more elements providing a point of attachment for a CPAP apparatus. In still further embodiments, the device comprises a point of attachment for the tubing associated with a CPAP apparatus. In some embodiments, the device is capable of being adjustably fitted to a human head. FIG. 1 depicts embodiments of a headgear device 100 comprising a single fabric tube. Referring to FIG. IA, the single-piece construction of a device distributes the tension 102 holding the device to the head essentially evenly across portions of a head 104 received within the device 100. Referring to FIG. IB, the tension 102 is distributed over a wide surface area so that in any given location, the force is small. In embodiments, a device 100 does not contain, for example, one, two, or three straps or separate fasteners that focus the tension on a number of foci equal to the number of separate fasteners. FIG. 2 depicts further embodiments of a headgear device 100. FIG. 2A and

FIG. 2B depict embodiments comprising a single piece of material. The device 100 may comprise a top portion 200 substantially covering the front 202, top 204, and back 206 of a human head 104 received within the device 100. The device may further comprise a chin strap portion 208. The chin strap portion 208 may extend from one side of the device (FIG. 2B depicts a chin strap portion 208 extending from left-side of a device 100). The chin strap portion 208 may extend from a point of extension 210 that may be located, for example, over the side of a human head 104 received within the device. Alternatively, the chin strap portion 208 may be completely removable from the device 100. FIG. 2C depicts an embodiment wherein the chin strap portion 208 is completely removable from the device 100. Because the device 100 may comprise a top portion 200 substantially covering the front 202, top 204, and back 206 of a human head 104 received within the device 100, one or more points of attachment 212 for a means of retaining a CPAP apparatus 300 in an operative position may be positioned variably to conform to the individual anatomy of the human subject utilizing the headgear device 100. These points of attachment 212 may be positioned broadly across the surface of the device 100, so that individuals with unusual anatomy, such as, for example, a high forehead, long nose, or hollow cheeks, may comfortably fit a device 100 of a single design to their individual comfort. Points of attachment 212 may include, by way of non-limiting example, hook and loop fasteners, Velstretch™ or other elastic loop tape, clips, buckles, ties, adhesives, and/or buttons. In embodiments wherein the chin strap portion 208 is completely removable from the device 100, the chin strap portion 208 may be attached to the device 100 at one or more points of attachment 212. Additionally, the device 100 may comprise one or more second points of attachment 214 for fastening the distal end 216 of a chin strap portion 208 to the top portion 200 of the device. Referring now to FIG. 3, therein is depicted a particular embodiment of a headgear device 100 with a human head 104 received within it, and a CPAP apparatus 300 simultaneously engaged with the face 106 of the human head 104. In FIG. 3 A, the CPAP apparatus 300 is engaged with the face 106 of the human head 104 in an operative position. In FIG. 3B, the CPAP apparatus is engaged with the face 106 of the human head 104 in an operative position, and is capable of being retained in the operative position by one or more fasteners 304. The fasteners 304 may be comprised of hook and loop fastener straps, Velstretch™, clips, buckles, buttons, ties, adhesive tape, or any other fastening mechanism known in the art. The fasteners 304 may securely hold the CPAP apparatus 300 in an operative position. These fasteners 304 may contact one or more points of attachment 212 on the headgear device 100. One or more of these fasteners 304 may contact, for example, a fabric loop 302 on the front of the top portion 200 of the headgear device 100, to which may be attached tubing 306 from a continuous positive airway pressure system in a fixed position to the front or top of the human head 104.

In some embodiments, the headgear device 100 further comprises at least one tab 400 which can be fastened to a first portion 402 of the device 100. By manually positioning the point 404 where the tab(s) 400 is/are fastened to the first portion 402 of the device 100, the tab(s) 400 may be used for adjustably fitting the device 100 to the human head 104. FIG. 4 illustrates such an embodiment in the unfastened (FIG. 4A) and fastened (FIG. 4B) positions. Fastening of the tab(s) 400 of the device 100 can be accomplished using a second fastener 406. Any fastener known to those of skill in the art may be used. For example, hook and loop fastener straps, Velstretch™, clips, buckles, buttons, ties, and/or adhesive tape may be used. In some embodiments, a second portion 408 of the device 100 may positioned between the tab(s) 400, or the point 404 where the tab(s) is/are fastened to the first portion 402 of the device. This second portion 408 may provide comfort to the human subject by occluding the second fastener 406 from directly contacting the human head 104. In some embodiments, by manually pulling the tab(s) 400 across the second portion 408 of the device 100 toward the configuration shown in FIG. 4B, the human subject may cause the device to conform to the specific dimensions of his/her head 104. In further embodiments, the device 100 further comprises one or more openings 410 between the tab(s) 400 and the first portion 402. Said opening 410 may be positioned such that, when the tab(s) 400 is/are pulled to contact the first portion 402, the portions of the device 100 do not collect uncomfortably and "bunch" in the area between the tab(s) 400 and the first portion 402. Embodiments of a headgear device according to the present disclosure may additionally comprise features for a variety of purposes, including, for example, additional comfort, increased compatibility with assisted breathing devices, compatibility with orthodontic hardware or accessories, and compatibility with head- or face-protective devices. Such additional features include, for example, cushions placed between the device and the human head, sound retarding obstructions over the ears, and blindfolds.

//. A method for treating a breathing disorder in a human subject. Specifically illustrated embodiments may be useful to facilitate treatment of a breathing disorder in a human subject, for example, OSA. Human subjects afflicted with a breathing disorder, for example, OSA, are fitted with a headgear device according to the present disclosure prior to an attempt by the subject to obtain restful sleep. The human subject may then adjust the headgear device so that it conforms to the specific dimensions of the head of the human subject. The human subject may then be engaged with a CPAP apparatus in an operative position, and the CPAP apparatus may be further engaged with the headgear device so that it is capable of being retained in an operative position while the subject is asleep.

Specific embodiments of headgear devices according to the present method may be used in combination with other ameliorative therapies for breathing disorders. Other ameliorative therapies for breathing disorders include, for example, neck pillows and neck braces. Such other ameliorative therapies may be combined with specific embodiments, for example, to provide additional support for the mouth of the human subject in a closed position. Specific embodiments of headgear devices according to the present method may also be used in combination with techniques and devices useful in improving sleep. Such techniques and devices include, for example, eye shields, earplugs, and aromatherapy.

While this disclosure has described certain embodiments, the present embodiments may be further modified within the spirit and scope of this disclosure. This application is therefore intended to cover any variations, uses, or adaptations of the present disclosure using general principles. Further, this application is intended to cover such departures from the present disclosure as come within known or customary practice in the art to which this disclosure pertains and which fall within the limits of the appended claims.

Claims

CLAIMS What is claimed is:

1. A device for receiving a human head, said device comprising: at least one means for adjustably fitting the device to the human head; a chin portion capable of engaging a human chin; and a portion capable of engaging a continuous positive airway pressure system in an operative position on the head; wherein the tension holding the device against the head of the human subject is distributed across the head of the human subject.

2. The device according to claim 1, wherein the tension holding the device against the head of the human subject is distributed essentially evenly across the top and back of the head of the human subject.

3. The device according to claim 1, wherein the tension is distributed over a wide surface area.

4. The device according to claim 1, wherein the device does not comprise a continuous positive airway pressure interface.

5. The device according to claim 1, wherein the device further comprises one or more cushions, wherein said cushions contact the human head.

6. The device according to claim 5, the cushions further comprising: a first surface contacting the chin of the human head; and a second surface contacting the chin portion of the device.

7. The device according to claim 5, wherein the cushions dampen the passage of external sound to the ear of a human head received within the device.

8. The device according to claim 1, wherein the device is constructed of stiff material.

9. The device according to claim 1 , wherein the device is constructed of a material selected from a group comprising cotton, leather, silk, and natural fibers.

10. The device according to claim 1, wherein the device further comprises a portion separating the forehead mount of a continuous positive airway pressure system from the head of the human head.

11. The device according to claim 1, the chin portion further comprising one or more means for reversibly detaching the chin portion from the device at one or more points of contact.

12. The device according to claim 1 , wherein the device is machine washable.

13. The device according to claim 1 , the device further comprising a means for attaching to the device tubing from a continuous positive airway pressure system in a fixed position at the front or top of the human head.

14. The device according to claim 1, the device further comprising one or more elements capable of removably retaining a continuous positive airway pressure system in contact with the head in an operative position.

15. The device according to claim 1 , wherein the portion capable of engaging a continuous positive airway pressure system in an operative position on the head is capable of removably retaining a continuous positive airway pressure system in contact with the head in an operative position.

16. A device for receiving the head of a human, said device comprising: a first end that engages the top of the head; a second end that engages the chin of the human; and a surface defining a space capable of receiving the face and mouth of the human; wherein a continuous positive airway pressure system is capable of being engaged in an operative position with the head when the head is received within the device; and wherein the tension is distributed over a wide surface area.

17. The device according to claim 16, wherein the device does not comprise a continuous positive airway pressure interface.

18. The device according to claim 16, wherein the device is of unitary construction.

19. The device according to claim 16, wherein the device further comprises one or more cushions, said cushions contacting the head.

20. The device according to claim 16, wherein the device further comprises one or more means for removably retaining a continuous positive airway pressure system in contact with the head in an operative position.

21. The device according to claim 16, wherein the device is machine washable.

22. The device according to claim 16, the device further comprising a means for attaching to the device tubing from a continuous positive airway pressure system in a fixed position at the front or top of the human head.

23. The device according to claim 16, wherein the device is constructed of stiff material.

24. The device according to claim 23, wherein the device is constructed of a material selected from a group comprising cotton, leather, silk, and natural fibers.

25. A method for treating a breathing disorder in a human subject comprising: receiving the head of the human subject in a device, the device comprising: one or more means for adjustably fitting the device to the human head; wherein the device is capable of securely holding a continuous positive airway pressure apparatus in an operative position when the head of the human subject is received within the device; wherein the device is capable of exerting a force on the chin of the human subject such that the mouth of the human subject is biased toward a closed position; and attaching a continuous positive airway pressure interface to the device.

26. The method according to claim 25, wherein the tension holding the device against the head of the human subject is distributed essentially evenly across the top and back of the head of the human subject.

27. The method according to claim 25, wherein the tension is distributed over a wide surface area.

28. The method according to claim 25, wherein the breathing disorder is obstructive sleep apnea.

29. The method according to claim 25, the method further comprising allowing the human subject to sleep.

30. The method according to claim 25, the method further comprising treating the human subject with a continuous positive airway pressure system.

31. The method according to claim 25, the method further comprising adjustment of the device to conform to the specific dimensions of the head of the human subject.

32. The method according to claim 25, the method further comprising maintaining a seal between the continuous positive airway pressure system and the head of the human subject.

33. The method according to claim 25, the method further comprising administering a neck pillow to the human subject.

34. The method according to claim 26, the method further comprising administering a neck brace to the human subject.