Primary Endpoints: •Comparison of difference in AHI at one-week in-lab polysomnography between "device on" and "device off" nights, controlling for sleep position (supine vs. non-supine) Secondary Endpoints: By polysomnography, reduction in: * AHI with device on vs. off at 3 months, controlling for sleep position * Oxygen desaturation index with device on vs. off * Arousal index with device on vs. off * Duration of snoring with device on vs. off * Epworth Sleepiness Scale Patient acceptance, in terms of: * Refusal rate at screening * Discontinuation rate during follow-up * Daily compliance rate * Device-related adverse events * Serious adverse events
Please see summary above
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
250
Application of active device (Provent)
Sham device will be applied
Pulmonary Associates
Glendale, Arizona, United States
Pulmonary Associates
Phoenix, Arizona, United States
Stanford Center for Human Sleep Research
Redwood City, California, United States
Gaylord Sleep Medicine
Wallingford, Connecticut, United States
University Of Florida College of Medicine
Gainesville, Florida, United States
Sleep Disorders Center of Georgia
Atlanta, Georgia, United States
Chicago Sleep Group of Suburban Lung Associates
Elk Grove Village, Illinois, United States
Kentucky Research Group
Louisville, Kentucky, United States
Sleep Health Center
Brighton, Massachusetts, United States
Wayne State University
Detroit, Michigan, United States
...and 7 more locations
Comparison of difference in AHI at one-week in-lab polysomnography between "device on" and "device off" nights, controlling for sleep position (supine vs. non-supine)
Time frame: 3 months
Reduction in AHI, Oxygen desat index, Arousal index & Duration of snoring w/ device on/off;ESS,Patient acceptance,Device-related AEs & SAEs
Time frame: 3 months
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