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 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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
900
Continuous negative external pressure (cNEP) system that maintains an open airway by applying negative pressure to the anterior neck via a soft silicone collar
University of Arizona
Tucson, Arizona, United States
Preferred Research Partners
Little Rock, Arkansas, United States
Infinitive Bioresearch
Los Angeles, California, United States
Sustained response to aerSleep II therapy at 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.
Time frame: 24 weeks
Adverse Device Effects
The primary safety endpoint is to characterize the adverse device effects experienced throughout the study.
Time frame: 24 weeks
ODI change
Demonstrate a change in Oxygen Desaturation Index (ODI) at HST #4 compared to baseline HST for initial responders
Time frame: 24 weeks
AHI change from baseline for all subjects that acclimate to the aerSleep II device
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
Time frame: 24 weeks
Change in sleep disturbance from baseline as measured by Patient Reported Outcomes Measurement Information System (PROMIS) Sleep Disturbance questionnaire
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
Time frame: 24 weeks
Change in sleep impairment from baseline as measured by PROMIS Sleep Sleep-Related Impairment questionnaire
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
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BetterNight
San Diego, California, United States
Delta Waves
Colorado Springs, Colorado, United States
Baptist Hospital
Miami, Florida, United States
Clayton Sleep Institute
St Louis, Missouri, United States
The MetroHealth System
Cleveland, Ohio, United States
Cleveland Clinic Foundation
Cleveland, Ohio, United States
The Ohio State University
Columbus, Ohio, United States
...and 5 more locations
Time frame: 24 weeks
Change in sleep from baseline as measured by Patient Global Impression Scale questionnaire
Determine any change in sleep at the end of the study from baseline as measured by the Patient Global Impression Scale questionnaire
Time frame: 24 weeks