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

Sponsor

Walter Reed Army Medical Center (U.S. Fed)

Overall Status

Completed

CT.gov ID

NCT00612157

Collaborator

Sunovion (Industry)

154

Enrollment

Location

Arms

Duration (Months)

11.8

Patients Per Site Per Month

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Obstructive Sleep Apnea	Drug: Eszopiclone Drug: Placebo control	Phase 4

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 Design

Study Type:

Interventional

Anticipated Enrollment :

154 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Supportive Care

Official Title:

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

Study Start Date :

Jan 1, 2008

Actual Primary Completion Date :

Jun 1, 2008

Actual Study Completion Date :

Feb 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: OSA CPAP	Drug: Eszopiclone Eszopiclone 3mg orally at bedtime for 14 nights Other Names: Lunesta
Placebo Comparator: Placebo	Drug: Placebo control Matching placebo

Arm

Intervention/Treatment

Active Comparator: OSA CPAP

Drug: Eszopiclone

Eszopiclone 3mg orally at bedtime for 14 nights

Other Names:

Lunesta

Placebo Comparator: Placebo

Drug: Placebo control

Matching placebo

Outcome Measures

Primary Outcome Measures

Short term CPAP Compliance [3 months]
Intermediate CPAP Compliance [1 year]

Secondary Outcome Measures

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 - Sleepiness [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 - Subjective Sleep Quality [1 month, 3 months, 6 months, 9 months, 12 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 64 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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