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NCT00772044 · ClinicalTrials.gov registry record · Phase 4

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

A Phase 4 study of OSA and Obstructive Sleep Apnea Hypopnea, sponsored by Ventus Medical.

Completed
Registry status
Phase 4
Development phase
250
Enrollment target
17
Study locations

NCT00772044 is a Phase 4 study of OSA and Obstructive Sleep Apnea Hypopnea that has completed, run by Ventus Medical. The registered enrollment target is 250 participants, above the 147-participant average among 14 other OSA trials with a reported enrollment target (70% higher). The trial reports 17 study locations across 14 states.

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The verdict

NCT00772044, a Phase 4 study of OSA and Obstructive Sleep Apnea Hypopnea, has completed, sponsored by Ventus Medical.

COMPLETED
Registry status
Phase 4
Development phase
250 participants
Enrollment target
17
Study locations

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 Studied

OSA Obstructive Sleep Apnea Hypopnea OSAH

Interventions

  • DEVICE Sham Device
  • DEVICE Provent Professional Sleep Apnea Therapy Device

Study Locations (17)

Arizona

  • Pulmonary Associates - Glendale
  • Pulmonary Associates - Phoenix

Michigan

  • Wayne State University - Detroit
  • Borgess Research Institute - Kalamazoo

Texas

  • Sleep Medicine Associates of Texas - Dallas
  • Sleep Therapy and Research Center - San Antonio

California

  • Stanford Center for Human Sleep Research - Redwood City

Connecticut

  • Gaylord Sleep Medicine - Wallingford

Florida

  • University Of Florida College of Medicine - Gainesville

Georgia

  • Sleep Disorders Center of Georgia - Atlanta

Illinois

  • Chicago Sleep Group of Suburban Lung Associates - Elk Grove Village

Trial Details

FieldValue
Enrollment Target 250 participants
Start Date 2008-11
Est. Completion 2009-12
Phase Phase 4

Sponsor

Ventus Medical

2 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT00772044

The ClinicalTrials.gov registry entry for NCT00772044 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 250 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 147-participant average among 14 other OSA trials with a reported enrollment target (70% higher). The listed sponsor is Ventus Medical, which has 2 total studies on file at ClinicalTrials.gov.

The record links to 3 conditions, with OSA appearing as the primary indexed condition, and to 2 interventions - of which Sham Device is the first listed.

NCT00772044 reports 17 study locations spanning 14 distinct geographic areas - top geographies include Arizona, Michigan, Texas.

Frequently Asked Questions

What is clinical trial NCT00772044 about?

NCT00772044 is a clinical study titled "Randomized Study of Provent Versus Sham Device to Treat Obstructive 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 f...

What is the current status of trial NCT00772044?

This trial is currently completed. It is a Phase 4 study. The enrollment target is 250 participants. The study started on 2008-11. Estimated completion is 2009-12.

What conditions does trial NCT00772044 study?

This clinical trial studies the following conditions: OSA, Obstructive Sleep Apnea Hypopnea, OSAH.

What interventions are being tested in trial NCT00772044?

The interventions under investigation include: Sham Device (DEVICE), Provent Professional Sleep Apnea Therapy Device (DEVICE).

Who is sponsoring clinical trial NCT00772044?

This trial is sponsored by Ventus Medical, which has 2 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT00772044 being conducted?

This trial has 17 study locations across Arizona, California, Connecticut, Florida, Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.