Study Using Negative Pressure to Reduce Apnea
Study Using Negative Pressure to Reduce Apnea
The objective of this study is to determine the safety and effectiveness of the aerSleep® II
 device for treatment of moderate to severe Obstructive Sleep Apnea (OSA) over 24 weeks of
 home use in spontaneously breathing adult subjects who are intolerant of Continuous Positive
 Airway Pressure (CPAP) therapy.
This is a multi-center, single-arm, prospective, observational intervention study to
 determine the safety and effectiveness of the aerSleep II System. Up to 200 subjects will be
 enrolled at up to ten study sites in the United States to ensure that approximately 79
 subjects who are termed initial responders can be evaluated after 24 weeks of home use with
 the aerSleep II device. As part of screening and prior to intervention, home sleep testing
 will be performed to establish baseline apnea-hypopnea index (AHI). Subjects meeting study
 criteria will wear the aerSleep II device at home. After a 1-week period of acclimation,
 subjects will have a second HST (HST #2). Initial responders with a ≥50% reduction in AHI
 from baseline with an AHI <20/hour will be continued on home treatment. Non-responders will
 be discontinued from the study. After 12 weeks, subjects will have an interim home sleep
 study. After 24 weeks of home use, subjects will have HST #4 to determine the primary
 effectiveness endpoint.
Inclusion Criteria:

 1. Age ≥ 18 years old

 2. Body mass index <38 kg/m2

 3. Prior documented diagnosis of OSA by means of a polysomnography (PSG) test or home
 sleep test (HST)

 4. Documented evidence from a screening HST following consent to demonstrate:

 1. AHI 15 - 50/hour

 2. >80% of the apneas and hypopneas are obstructive

 5. Previous treatment attempt with CPAP resulting in failure to treat or discontinuation
 due to intolerance, subject choice, or struggle to use CPAP

 6. Have not used CPAP or oral appliances within 1 week of the screening home sleep test
 and agree not to use CPAP or oral appliances throughout the study duration

 7. Access to and ability to use a smart device such as a smartphone or tablet

 8. Able to speak, read, and write English

 9. In the opinion of the investigator, the subject will be able to understand and comply
 with all study procedures.

 Exclusion Criteria:

 1. Known sleep disorder other than OSA, such as narcolepsy, restless leg syndrome,
 idiopathic hypersomnolence or chronic insomnia

 2. Craniofacial abnormalities that may be contributing to OSA

 3. Previous surgery, injury, or radiation to the neck which, in the Investigator's
 judgment, could interfere with collar fit or comfort

 4. Excessive hair or beard in the area of the neck where the collar will be placed,
 and/or unwillingness to shave that area for the duration of this study

 5. Inflammatory skin condition, such as acne or eczema in the area where the collar will
 be affixed to the skin, which, in the Investigator's judgment, could interfere with
 collar fit or comfort

 6. Known silicone allergy

 7. Night shift work because of irregular sleep-wake cycles

 8. Excessive alcohol intake, defined as that leading to interference with work, home
 life, or the ability to optimally perform normal everyday duties and tasks

 9. Use of illicit drugs (including marijuana) currently or within the past 5 years

 10. Serious pulmonary disease (e.g., cor pulmonale, CO2 retention, or poorly controlled
 asthma)

 11. Use of home oxygen or baseline oxygen saturation <94%

 12. Cancer that has been in remission for less than one year

 13. Psychiatric illness that, in the opinion of the Investigator, is not reasonably
 well-controlled with treatment

 14. Serious cardiac disease (e.g., congestive heart failure, unstable coronary artery
 disease, or poorly controlled rhythm disturbance)

 15. Prior carotid endarterectomy, prior percutaneous coronary angiography (including any
 placement of carotid stents), or known stenosis of either internal carotid artery >
 70% from prior carotid imaging (e.g., carotid duplex ultrasound, angiography, computed
 tomography angiography, or magnetic resonance angiography)

 16. Previous surgery for peripheral arterial disease

 17. Presence of possible or definite carotid artery disease, defined as any of the
 following:

 1. history of cerebrovascular accident (CVA) or transient ischemic attack (TIA) with
 uncertain etiology that is compatible with carotid artery disease

 2. diminished carotid pulse on screening physical examination*

 3. > 70% stenosis in either extra-cranial internal carotid artery as determined by
 duplex ultrasound* (only performed on those who do not exhibit 17 a. or b.)

 18. Tonsil size 3 or 4 (Appendix C)*

 19. Currently pregnant* or planning to become pregnant during participation in this study

 20. Unable to obtain adequate collar fit*

 21. Any condition or circumstance that, in the opinion of the investigator, may preclude
 study completion, interfere with accurate data collection, or bias the results

 22. The investigator believes that the subject's participation may not be in his or her
 best interest