NCT00612157

Continuous Positive Airway Pressure (CPAP) Promotion And Prognosis - the Army Sleep Apnea Program (ASAP)

Prospective, Randomized, Double-Blind, Placebo-Controlled Trial Assessing the Effect of Eszoplicone on Initial Continuous Positive Airway Pressure (CPAP) Compliance

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 154 (estimated)
• Sponsor: Walter Reed Army Medical Center · Federal
• Sex: All
• Age: 18 Years – 64 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to assess the efficacy of Eszopiclone in improving short and intermediate-term compliance with continuous positive airway pressure (CPAP) in patients newly diagnosed with obstructive sleep apnea (OSA).

Detailed description

CPAP is the treatment of choice for patients with OSA. However, patients are frequently intolerant of this therapy initially. After continued use, tolerance is achieved. However, this initial discomfort or intolerance frequently leads to a patient-initiated discontinuation of therapy. It has been shown that CPAP use at 1 month predicts use at 6 months and 1 year. Patients who initially struggle with or are intolerant of CPAP frequently abandon therapy and are unlikely to use it long term. To prevent this, sleep physicians often prescribe short courses of sedatives to help improve initial tolerance and promote better compliance with therapy. However, the effectiveness of this practice has not been validated in a clinical trial. Compliance, in reference to this study is the willingness of the patients to follow the prescribed course of treatment.

Conditions

• Obstructive Sleep Apnea

Interventions

Type	Name	Description
DRUG	Eszopiclone	Eszopiclone 3mg orally at bedtime for 14 nights
DRUG	Placebo control	Matching placebo

Timeline

• Start date: 2008-01-01
• Primary completion: 2008-06-01
• Completion: 2009-02-01
• First posted: 2008-02-11
• Last updated: 2009-02-26

Locations

1 site across 1 country: United States