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

February 25, 2009 updated by: Walter Reed Army Medical Center

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

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

154

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • District of Columbia
      • Washington, District of Columbia, United States, 20307
        • Walter Reed Army Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 64 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Short term CPAP Compliance
Time Frame: 3 months
3 months
Intermediate CPAP Compliance
Time Frame: 1 year
1 year

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Walter Reed Army Medical Center

Collaborators

Sunovion

Investigators

  • Principal Investigator: Christopher J Lettieri, MD, Walter Reed Army Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2008

Primary Completion (Actual)

June 1, 2008

Study Completion (Actual)

February 1, 2009

Study Registration Dates

First Submitted

January 29, 2008

First Submitted That Met QC Criteria

February 8, 2008

First Posted (Estimate)

February 11, 2008

Study Record Updates

Last Update Posted (Estimate)

February 26, 2009

Last Update Submitted That Met QC Criteria

February 25, 2009

Last Verified

February 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • WRAMC07-17022

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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