Status:
ACTIVE_NOT_RECRUITING
Study Using Negative Pressure to Reduce Apnea
Lead Sponsor:
Sommetrics, Inc.
Conditions:
Sleep Apnea, Obstructive
Apnea, Sleep
Eligibility:
All Genders
18+ years
Phase:
NA
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 spont...
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 s...
Eligibility Criteria
Inclusion
- Age ≥ 18 years old
- Body mass index ≤42 kg/m2
- Prior documented diagnosis of OSA by means of a polysomnography (PSG) test or home sleep test (HST)
- Documented evidence from a screening HST following consent to demonstrate:
- AHI 15 - 50/hour
- \>80% of the apneas and hypopneas are obstructive
- Previous treatment attempt with CPAP resulting in failure to treat or discontinuation due to intolerance, subject choice, or struggle to use CPAP
- 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
- Access to and ability to use a smart device such as a smartphone or tablet
- Able to speak, read, and write English
- In the opinion of the investigator, the subject will be able to understand and comply with all study procedures.
Exclusion
- Known sleep disorder other than OSA, such as narcolepsy, restless leg syndrome, idiopathic hypersomnolence or chronic insomnia
- Craniofacial abnormalities that may be contributing to OSA
- Previous surgery, injury, or radiation to the neck which, in the Investigator's judgment, could interfere with collar fit or comfort
- 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
- 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
- Known silicone allergy
- Night shift work because of irregular sleep-wake cycles
- Excessive alcohol intake, defined as that leading to interference with work, home life, or the ability to optimally perform normal everyday duties and tasks
- Use of illicit drugs currently or within the past 5 years
- Serious pulmonary disease (e.g., cor pulmonale, CO2 retention, or poorly controlled asthma)
- Use of home oxygen or baseline oxygen saturation \<94%
- Cancer that has been in remission for less than one year
- Psychiatric illness that, in the opinion of the Investigator, is not reasonably well-controlled with treatment
- Serious cardiac disease (e.g., congestive heart failure, unstable coronary artery disease, or poorly controlled rhythm disturbance)
- 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)
- Previous surgery for peripheral arterial disease
- Presence of possible or definite carotid artery disease, defined as any of the following:
- history of cerebrovascular accident (CVA) or transient ischemic attack (TIA) with uncertain etiology that is compatible with carotid artery disease
- diminished carotid pulse on screening physical examination\*
- \> 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.)
- Tonsil size 3 or 4 (Appendix C)\*
- Currently pregnant\* or planning to become pregnant during participation in this study
- Unable to obtain adequate collar fit\*
- Any condition or circumstance that, in the opinion of the investigator, may preclude study completion, interfere with accurate data collection, or bias the results
- The investigator believes that the subject's participation may not be in his or her best interest
Key Trial Info
Start Date :
November 29 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2025
Estimated Enrollment :
900 Patients enrolled
Trial Details
Trial ID
NCT04861038
Start Date
November 29 2021
End Date
December 1 2025
Last Update
April 16 2024
Active Locations (15)
Enter a location and click search to find clinical trials sorted by distance.
1
University of Arizona
Tucson, Arizona, United States, 85719
2
Preferred Research Partners
Little Rock, Arkansas, United States, 72211
3
Infinitive Bioresearch
Los Angeles, California, United States, 90048
4
BetterNight
San Diego, California, United States, 92123