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COMPLETED Phase 4

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

NCT00772044 · View on ClinicalTrials.gov ↗

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

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

1 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. It is categorized as Phase 4, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 250 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Ventus Medical, which has 1 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT00772044 reports 17 study locations spanning 14 distinct geographic areas — top geographies include Arizona, Michigan, Texas. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT00772044?

The interventions under investigation include: Sham Device (DEVICE), Provent Professional Sleep Apnea Therapy Device (DEVICE). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT00772044?

This trial is sponsored by Ventus Medical, which has 1 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

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