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Randomized Study of Provent Versus Sham Device to Treat Obstructive Sleep Apnea

Ventus Medical, Inc. · 2008
ClinicalTrials.gov · Datasets · License: Public Domain · 2008
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sleep-apnea
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
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