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

Phase 4

Completed

• Conditions: Obstructive Sleep Apnea
• Interventions: Drug: Placebo control; Drug: Eszopiclone

• Registration Number: NCT00612157
• Lead Sponsor: Walter Reed Army Medical Center

Brief 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.

Study Timeline

• Study Start: 2008-01
• Study First Submitted: 2008-01-29
• Study First Submitted QC: 2008-02-08
• Study First Posted: 2008-02-11
• Primary Completion: 2008-06
• Status Verified: 2009-02
• Study Completion: 2009-02
• Last Update Submitted: 2009-02-25
• Last Update Posted: 2009-02-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 154

Inclusion Criteria

• Adult patients
• Newly diagnosed with OSA who are prescribed CPAP therapy

Exclusion Criteria

• Patients < 18 years old
• Patients over 65 years
• Pregnant women
• Patients with chronic liver disease
• Patients who abuse alcohol
• Patients taking narcotics or using sedative-hypnotic agents such as Ambien, Klonopin or Benadryl

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo control	-
OSA CPAP	Eszopiclone	-

Primary Outcome Measures

Name	Time	Method
Short term CPAP Compliance	3 months
Intermediate CPAP Compliance	1 year

Secondary Outcome Measures

Name	Time	Method
Quality of Life Issue - Prostate Symptoms for men	1 month, 3 months, 6 months, 9 months, 12 months
Quality of Life Issue - Erectile Dysfunction for men	1 month, 3 months, 6 months, 9 months, 12 months
Quality of Life Issue - Fatigue	1 month, 3 months, 6 months, 9 months, 12 months
Quality of Life Issue - Sleepiness	1 month, 3 months, 6 months, 9 months, 12 months
Quality of Life Issue - Subjective Sleep Quality	1 month, 3 months, 6 months, 9 months, 12 months

Trial Locations

Locations (1)

Walter Reed Army Medical Center; 🇺🇸 Washington, District of Columbia, United States