Effects of Treatment of Sleep Apnea on Metabolic Syndrome

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.

Conditions

• Impaired Glucose Tolerance
• Obstructive Sleep Apnea

Interventions

DEVICE

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

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

DEVICE

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

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

Sponsors & Collaborators

• National Institutes of Health (NIH)

  collaborator NIH

• National Center for Research Resources (NCRR)

  collaborator NIH

• Beth Israel Deaconess Medical Center

  collaborator OTHER

• Case Western Reserve University

  collaborator OTHER

• Brigham and Women's Hospital

  lead OTHER

Principal Investigators

• 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

• 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

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

CROSSOVER

Eligibility

Min Age

18 Years

Max Age

75 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2004-01-31

Primary Completion

2008-09-30

Completion

2008-09-30