Apnea, Sleep, Sleep Apnea, Obstructive
Conditions
Keywords
sleep apnea, OSA, obstructive sleep apnea, CPAP failure, apnea
Brief summary
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.
Detailed description
This is a multi-center, single-arm, prospective, observational intervention study to determine the safety and effectiveness of the aerSleep II System. Up to 900 subjects will be enrolled at up to 30 study sites in the United States and outside 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.
Interventions
DEVICEaerSleep II
Continuous negative external pressure (cNEP) system that maintains an open airway by applying negative pressure to the anterior neck via a soft silicone collar
Sponsors
Sommetrics, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Age ≥ 18 years old 2. Body mass index ≤42 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 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Sustained response to aerSleep II therapy at 24 weeks | 24 weeks | The primary effectiveness endpoint is to demonstrate that a majority of adult subjects who are initial responders to aerSleep II therapy experience a change of at least 50% of their baseline AHI with an AHI rate less than 20 per hour at the final home sleep test at 24 weeks. |
| Adverse Device Effects | 24 weeks | The primary safety endpoint is to characterize the adverse device effects experienced throughout the study. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in sleep disturbance from baseline as measured by Patient Reported Outcomes Measurement Information System (PROMIS) Sleep Disturbance questionnaire | 24 weeks | Determine the change in sleep disturbance at the end of the study compared to baseline using the validated PROMIS Short Form Sleep Disturbance 8b questionnaire |
| ODI change | 24 weeks | Demonstrate a change in Oxygen Desaturation Index (ODI) at HST #4 compared to baseline HST for initial responders |
| Change in sleep from baseline as measured by Patient Global Impression Scale questionnaire | 24 weeks | Determine any change in sleep at the end of the study from baseline as measured by the Patient Global Impression Scale questionnaire |
| Change in sleep impairment from baseline as measured by PROMIS Sleep Sleep-Related Impairment questionnaire | 24 weeks | Determine the change in sleep impairment at the end of the study from baseline as measured by the validated PROMIS Short Form Sleep-Related Impairment 8a questionnaire |
| AHI change from baseline for all subjects that acclimate to the aerSleep II device | 24 weeks | Determine the proportion of subjects that acclimate to the device that exhibit a change in AHI after 24 weeks of home use with the aerSleep II device |
Countries
United States
Outcome results
None listed