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Completed

NCT Number: NCT00612157

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

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).

Completed

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Key information

Age range

18 year–64 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Walter Reed Army Medical Center

Washington D.C., District of Columbia, 20307, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Eszopiclone

Drug

Eszopiclone 3mg orally at bedtime for 14 nights

Other names: Lunesta

Placebo Control

Drug

Matching placebo

Primary outcomes

  1. Short term CPAP Compliance

    Time frame: 3 months

  2. Intermediate CPAP Compliance

    Time frame: 1 year

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Walter Reed Army Medical Center

Fed

Collaborators

  • Sumitomo Pharma America, Inc.

Registry information

Official study title

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

Acronym: CPAPASAP

Important dates

Study start
2008
Primary completion
2008
Study completion
2009
First posted
Feb 11, 2008
Registry last updated
Feb 26, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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