CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 50 enrolled
Drug / intervention
Continuous Positive Airway Pressure (CPAP) (Philips-Respironics RemStar Pro® CPAP) +1 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01385995
NCT01385995Phase 2Completed

A Controlled Trial of Continuous Positive Airway Pressure (CPAP) Therapy on Metabolic Control in Individuals With Impaired Glucose Tolerance and Sleep Apnea

Brigham and Women's Hospital·interventional·Posted Jun 30, 2011·Updated Mar 12, 2014

In Brief

A Phase 2 clinical trial evaluating Continuous Positive Airway Pressure (CPAP) (Philips-Respironics RemStar Pro® CPAP) and Sham-Continuous Positive Airway Pressure (CPAP) (Philips-Respironics) for Impaired Glucose Tolerance and Obstructive Sleep Apnea. Completed, enrolled 50 participants.

Detailed Summary

The investigators performed a randomized, cross-over controlled clinical trial comparing 8 weeks of Continuous Positive Airway Pressure (CPAP) to 8 weeks of sham-CPAP in patients with moderate to severe Sleep Disordered Breathing (SDB) and impaired glucose tolerance. A rigorous assessment of metabolic responses to SDB treatment in this group is of great clinical significance because this sample is at high risk for developing diabetes. The paradigm shift of CPAP as a mode of prevention can affect clinical practice in the fields of both primary care and sleep medicine.

Study Details

Timeline

Phase 2CompletedFinished
200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJun 30, 2011
Enrollment StartJan 1, 2004
Primary CompletionSep 1, 2008
TodayJul 2, 2026
Enrollment to primary: 4.7 yearsPosted 15.0 years ago

Interventions

Continuous Positive Airway Pressure (CPAP) (Philips-Respironics RemStar Pro® CPAP)device

Subjects will be randomized to 8 weeks of CPAP or sham-CPAP, followed by the alternate therapy after a one month wash-out.

Sham-Continuous Positive Airway Pressure (CPAP) (Philips-Respironics)device

Subjects will be randomized to 8 weeks of CPAP or sham-CPAP, followed by the alternate therapy after a one month wash-out.