Reimagining Therapy for Obstructive Sleep Apnea
- Age 18 or older
- Have a diagnosis of OSA that is considered to be moderate or severe
- Are unable or unwilling to use CPAP as a form of treatment
- During screening and the rest of the study, you cannot use other therapy such as CPAP or an oral appliance
- Able to speak, read, and write English and have access to a smart phone or tablet
- Cannot have a beard that interferes with the aerSleep II
- Cannot have other sleep disorders or serious illness, history of disease in your neck blood vessels, surgery to the head and neck, stroke or use of home oxygen
- Have a health exam
- Undergo 2 ultrasound tests to look at your neck blood vessels
- Have 4 home sleep tests
- Wear the aerSleep II every night as much as possible
- Come to the clinic at least 3-4 times and have video calls with study staff every 2 weeks
Clinical Trial Locations
- Tucson, Arizona
- Miami, Florida
- Columbia, South Carolina
- Philadelphia, PA
- Pittsburgh, PA
- Cleveland, OH
- Columbus, OH
- External Negative pressure
- Non claustrophobic
- Comfortable Patient interface
- No masks or hoses
Clinical Trial NCT # 04861038
Frequently Asked Questions
What is being studied?
The study is testing a form of treatment for OSA called negative pressure using the aerSleep® II System (aerSleep II). The study sponsor is Sommetrics.
How does it work?
The individual places the aerSleep II, a silicone oval collar with a small pump, on the front of the neck and under the chin area. Once in place, the small pump creates a forward pulling or suction of the neck tissues into the collar, which opens the airway. There are no tubes, masks or electricity required.
How long does the study last?
Your participation in the study would last about 28 weeks if you qualify and go through all of the study procedures.
Will I be paid to be in the study?
Compensation is available to qualified participants. Study-related procedures and the study device will be provided at no cost.
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