Study Using Negative Pressure to Reduce Apnea
Last updated on July 2021Recruitment
- Recruitment Status
- Not yet recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Apnea, Sleep
- Sleep Apnea - Obstructive
- Type
- Interventional
- Phase
- Not Applicable
- Design
- Allocation: N/AIntervention Model: Single Group AssignmentMasking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
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 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 res...
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.
Tracking Information
- NCT #
- NCT04861038
- Collaborators
- Not Provided
- Investigators
- Principal Investigator: Kingman P. Strohl, M.D. Case Western Reserve University School of Medicine