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NCT01461473 · ClinicalTrials.gov registry record · NA

Comparative Outcomes Management With Electronic Data Technology (COMET) Study

A NA study of Sleep Apnea, Obstructive, sponsored by Stanford University.

Completed
Registry status
NA
Development phase
131
Enrollment target
4
Study locations

NCT01461473: Completed NA study of Sleep Apnea, Obstructive, sponsored by Stanford University.

NCT01461473 is a NA study of Sleep Apnea, Obstructive that has completed, run by Stanford University. The registered enrollment target is 131 participants, below the 259-participant average among 45 other Sleep Apnea, Obstructive trials with a reported enrollment target (49% lower). The trial reports 4 study locations across 4 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01461473, a NA study of Sleep Apnea, Obstructive, has completed, sponsored by Stanford University.

COMPLETED
Registry status
NA
Development phase
131 participants
Enrollment target
4
Study locations

Study Summary

STAGE I of the COMET study was to develop an Electronic Network Informatics Infrastructure that prospectively enabled access to and the sharing of clinical and research data. STAGE II: This was a Comparative Effectiveness Trial (CET) evaluating positive airway pressure (PAP) vs. oral appliance (OA) therapy in improving hypertension and abnormalities in cardiovascular function in overweight/obese patients with obstructive sleep apnea (OSA). Data collected during the STAGE II study was incorporated in Part 3 of the STAGE I study. STAGE III of the COMET study was completion of data analysis and preparation of the electronic network informatics infrastructure for use beyond the four Clinical Centers to interested CTSA institutions. We also explored expanding ontologies, and the use of federated database methodology.

Conditions Studied

Sleep Apnea, Obstructive

Interventions

  • DEVICE Positive Airway Pressure (PAP)
  • DEVICE Oral Appliance (OA)

Study Locations (4)

California

  • Stanford Sleep Medicine Center - Redwood City

Massachusetts

  • Harvard Brigham and Women's Hospital - Boston

Pennsylvania

  • Center for Sleep and Circadian Neurobiology, University of Pennsylvania School of Medicine - Philadelphia

Wisconsin

  • University of Wisconsin-Madison School of Medicine, Department of Psychiatry - Madison

Trial Details

FieldValue
Enrollment Target 131 participants
Start Date 2011-12
Est. Completion 2014-06
Phase NA

Sponsor

Stanford University

1,744 total trials

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What the Registry Record Tells You About NCT01461473

The ClinicalTrials.gov registry entry for NCT01461473 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 131 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 259-participant average among 45 other Sleep Apnea, Obstructive trials with a reported enrollment target (49% lower). The listed sponsor is Stanford University, which has 1,744 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Sleep Apnea, Obstructive appearing as the primary indexed condition, and to 2 interventions - of which Positive Airway Pressure (PAP) is the first listed.

NCT01461473 reports 4 study locations spanning 4 distinct geographic areas - top geographies include California, Massachusetts, Pennsylvania.

Frequently Asked Questions

What is clinical trial NCT01461473 about?

NCT01461473 is a clinical study titled "Comparative Outcomes Management With Electronic Data Technology (COMET) Study". STAGE I of the COMET study was to develop an Electronic Network Informatics Infrastructure that prospectively enabled access to and the sharing of clinical and research data. STAGE II: This was a Comparative Effectiveness Trial (CET) evaluating positive airway pressure (PAP) vs. oral appliance (OA)...

What is the current status of trial NCT01461473?

This trial is currently completed. It is a NA study. The enrollment target is 131 participants. The study started on 2011-12. Estimated completion is 2014-06.

What conditions does trial NCT01461473 study?

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

What interventions are being tested in trial NCT01461473?

The interventions under investigation include: Positive Airway Pressure (PAP) (DEVICE), Oral Appliance (OA) (DEVICE).

Who is sponsoring clinical trial NCT01461473?

This trial is sponsored by Stanford University, which has 1,744 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT01461473 being conducted?

This trial has 4 study locations across California, Massachusetts, Pennsylvania, Wisconsin. 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

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, the data changelog, or report a data error.