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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00612157
Recruitment Status : Completed
First Posted : February 11, 2008
Last Update Posted : February 26, 2009
Information provided by:
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).

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 Type : Interventional  (Clinical Trial)
Estimated 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 : January 2008
Actual Primary Completion Date : June 2008
Actual Study Completion Date : February 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sleep Apnea
Drug Information available for: Eszopiclone

Arm Intervention/treatment
Active Comparator: OSA CPAP Drug: Eszopiclone
Eszopiclone 3mg orally at bedtime for 14 nights
Other Name: Lunesta

Placebo Comparator: Placebo Drug: Placebo control
Matching placebo

Primary Outcome Measures :
  1. Short term CPAP Compliance [ Time Frame: 3 months ]
  2. Intermediate CPAP Compliance [ Time Frame: 1 year ]

Secondary Outcome Measures :
  1. Quality of Life Issue - Prostate Symptoms for men [ Time Frame: 1 month, 3 months, 6 months, 9 months, 12 months ]
  2. Quality of Life Issue - Erectile Dysfunction for men [ Time Frame: 1 month, 3 months, 6 months, 9 months, 12 months ]
  3. Quality of Life Issue - Sleepiness [ Time Frame: 1 month, 3 months, 6 months, 9 months, 12 months ]
  4. Quality of Life Issue - Fatigue [ Time Frame: 1 month, 3 months, 6 months, 9 months, 12 months ]
  5. Quality of Life Issue - Subjective Sleep Quality [ Time Frame: 1 month, 3 months, 6 months, 9 months, 12 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 64 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00612157

United States, District of Columbia
Walter Reed Army Medical Center
Washington, District of Columbia, United States, 20307
Sponsors and Collaborators
Walter Reed Army Medical Center
Principal Investigator: Christopher J Lettieri, MD Walter Reed Army Medical Center

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Christopher J. Lettieri, MD / Pulmonary, Critical Care & Sleep Medicine, Walter Reed Army Medical Center Identifier: NCT00612157     History of Changes
Other Study ID Numbers: WRAMC07-17022
First Posted: February 11, 2008    Key Record Dates
Last Update Posted: February 26, 2009
Last Verified: February 2009

Keywords provided by Walter Reed Army Medical Center:
Obstructive Sleep Apnea
Continuous Positive Airway Pressure
CPAP Compliance
Non-benzodiazepine hypnotics

Additional relevant MeSH terms:
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Sleep Disorders, Intrinsic
Sleep Wake Disorders
Nervous System Diseases
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs