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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.

Primary Outcome

Mean arterial blood pressure during the sleep period as recorded by 24-hour ambulatory blood pressure monitoring after approximately 2 months of treatment

Conditions Studied

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
Stanford University

1,744 total trials

What the finished NCT01461473 record still lists

NCT01461473 is an interventional study that assigns participants to a tested intervention. The registered 131 participants enrollment target is mid-sized for trials with a published cap, below the 259-participant average among 45 other Sleep Apnea, Obstructive trials with a reported enrollment target (49% lower).

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 a single indexed study location in 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.

Similar trials for Sleep Apnea, Obstructive

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT01461473's enrollment target sits among peer trials

131 15th of 45 higher than 31 of 45 other Sleep Apnea, Obstructive trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Sleep Apnea, Obstructive trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT01461473, the US trial registry maintained by the National Library of Medicine. NCT01461473 (mid enrollment · single site footprint · completed) retrieved and formatted by PlainTrial, see methodology.