Effects of Treatment of Sleep Apnea on Metabolic Syndrome

Obstructive Sleep Apnea Clinical Trial

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

Status Completed

Clinical Trial 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.

Clinical Trial Description

There are few controlled studies that address whether treatment of sleep apnea improves glucose tolerance. This is a randomized, double-blind cross-over study of subjects with sleep apnea (apnea hypopnea index > 15) and impaired glucose tolerance. Subjects will be randomized to 8 weeks of Continuous Positive Airway Pressure (CPAP) or sham-CPAP, followed by the alternate therapy after a one month wash-out. After each treatment, subjects will undergo 2-hour oral glucose tolerance testing, polysomnography, actigraphy, and measurements of indices of glucose control. The investigators intend to analyze the changes in glucose metabolism and insulin sensitivity in patients with sleep apnea with CPAP intervention. ;

Study Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Apnea
• Glucose Intolerance
• Impaired Glucose Tolerance
• Obstructive Sleep Apnea
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive

• NCT number: NCT01385995
• Study type: Interventional
• Source: Brigham and Women's Hospital
• Status: Completed
• Phase: Phase 2
• Start date: January 2004
• Completion date: September 2008