At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
R01: Comparative Outcomes Management With Electronic Data Technology (COMET) Study
In Brief
A clinical study evaluating Positive Airway Pressure (PAP) and Oral Appliance (OA) for Sleep Apnea, Obstructive. Completed, enrolled 131 participants across 4 sites.
Detailed 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.
Study Details
Timeline
Interventions
Participants randomized to the Positive Airway Pressure treatment group received adequate Positive Airway Pressure (PAP) pressure therapy by a PAP titration study and used the device for 6 months.
Participants randomized to the Oral Appliance treatment group received a dental evaluation to determine the optimal setting for the Oral Appliance (OA), and used the appliance for 6 months.