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

OSA Clinical Trial

Official title: Randomized, Double-blind Study to Compare Safety and Effectiveness of the ProventTM Professional Sleep Apnea Therapy Device to Sham for the Non-invasive Treatment of OSAH

Status Completed

Clinical Trial Summary

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

Clinical Trial Description

Please see summary above ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Apnea
• Obstructive Sleep Apnea Hypopnea
• OSA
• OSAH
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive

• NCT number: NCT00772044
• Study type: Interventional
• Source: Ventus Medical, Inc.
• Status: Completed
• Phase: Phase 4
• Start date: November 2008
• Completion date: December 2009