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

NCT00772044 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 250

Last updated 2010-04-01

No results posted yet for this study

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

Conditions

  • Obstructive Sleep Apnea Hypopnea
  • OSA
  • OSAH

Interventions

DEVICE

Provent Professional Sleep Apnea Therapy Device

Application of active device (Provent)

DEVICE

Sham Device

Sham device will be applied

Sponsors & Collaborators

  • Ventus Medical, Inc.

    lead INDUSTRY

Principal Investigators

  • Richard B Berry, M.D. · University of Florida

  • Connie A Rey · Ventus Medical

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-11-30
Primary Completion
2009-09-30
Completion
2009-12-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00772044 on ClinicalTrials.gov