Sponsor study identifier
Secondary identifiers
NIH
interventional
50
0 countries
N/A
Study Start
January 2004
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
September 2008
Actual (reported)Study Completion
September 2008
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
September 2008
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
January 2004
Date type not reportedThis date has not been verified as actual or estimated.
September 2008
Actual (reported)September 2008
Actual (reported)June 23, 2011
Actual (reported)June 30, 2011
Actual (reported)July 26, 2012
Actual (reported)Number of Subjects With Normalization of Impaired Glucose Tolerance (IGT)
Number of subjects who experienced normalization of the mean 2-hour oral glucose tolerance test (OGTT) in the overall sample undergoing therapeutic CPAP vs. sham CPAP. (2-hour OGTT glucose\< 140 mg/dL)
20 weeks
Mean and Standard Deviation of Glucose Indices After Therapeutic CPAP vs. Sham
20 weeks
Mean and Standard Deviation of Insulin Indices After Therapeutic CPAP vs. Sham
20 weeks
Mean and Standard Deviation of Indices of Insulin Resistance With Therapeutic CPAP vs. Sham
20 weeks
Mean and Standard Deviation of Insulin Sensitivity Index (ISI(0,120)) With Therapeutic CPAP vs. Sham
20 Weeks
Subjects will be randomized to 8 weeks of CPAP or sham-CPAP, followed by the alternate therapy after a one month wash-out.
Weinstock TG, Wang X, Rueschman M, Ismail-Beigi F, Aylor J, Babineau DC, Mehra R, Redline S. A controlled trial of CPAP therapy on metabolic control in individuals with impaired glucose tolerance and sleep apnea. Sleep. 2012 May 1;35(5):617-625B. doi: 10.5665/sleep.1816.
Susan Redline, M.D., M.P.H.
Brigham and Women's Hospital
Faramarz Beigi
Case Western Reserve University
H Lester Kirchner, PhD
Case Western Reserve University
Carol Rosen, M.D.
Case Western Reserve University
50 participants (actual enrollment reported by the registry).
First Submitted
June 23, 2011
First Posted
June 30, 2011
Study Start
January 2004
Date type not reportedThis date has not been verified as actual or estimated.
Cognitive Effects of Aerobic Exercise for IGT Adults
Subjects will be randomized to 8 weeks of CPAP or sham-CPAP, followed by the alternate therapy after a one month wash-out.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
John Haaga, M.D.
Case Western Reserve University
Kingman Strohl, M.D.
Case Western Reserve University
Reena Mehra, M.S., M.S.
Case Western Reserve University
Denise Babineau, PhD
Case Western Reserve University
Tanya Weinstock, M.D.
Brigham and Women's Hospital
Primary Completion
September 2008
Actual (reported)Study Completion
September 2008
Actual (reported)Last Updated
March 12, 2014
Results First Posted
July 26, 2012
Record last verified: 2014-02
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
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