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

This study has been completed.
Sponsor:
Collaborator:
Sunovion
Information provided by:
Walter Reed Army Medical Center
ClinicalTrials.gov Identifier:
NCT00612157
First received: January 29, 2008
Last updated: February 25, 2009
Last verified: February 2009

January 29, 2008
February 25, 2009
January 2008
June 2008   (final data collection date for primary outcome measure)
  • Short term CPAP Compliance [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • Intermediate CPAP Compliance [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00612157 on ClinicalTrials.gov Archive Site
  • Quality of Life Issue - Prostate Symptoms for men [ Time Frame: 1 month, 3 months, 6 months, 9 months, 12 months ] [ Designated as safety issue: No ]
  • Quality of Life Issue - Erectile Dysfunction for men [ Time Frame: 1 month, 3 months, 6 months, 9 months, 12 months ] [ Designated as safety issue: No ]
  • Quality of Life Issue - Sleepiness [ Time Frame: 1 month, 3 months, 6 months, 9 months, 12 months ] [ Designated as safety issue: No ]
  • Quality of Life Issue - Fatigue [ Time Frame: 1 month, 3 months, 6 months, 9 months, 12 months ] [ Designated as safety issue: No ]
  • Quality of Life Issue - Subjective Sleep Quality [ Time Frame: 1 month, 3 months, 6 months, 9 months, 12 months ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Continuous Positive Airway Pressure (CPAP) Promotion And Prognosis - the Army Sleep Apnea Program (ASAP)
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).

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.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Obstructive Sleep Apnea
  • Drug: Eszopiclone
    Eszopiclone 3mg orally at bedtime for 14 nights
    Other Name: Lunesta
  • Drug: Placebo control
    Matching placebo
  • Active Comparator: OSA CPAP
    Intervention: Drug: Eszopiclone
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo control

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
154
February 2009
June 2008   (final data collection date for primary outcome measure)

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
Both
18 Years to 64 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00612157
WRAMC07-17022
Yes
Christopher J. Lettieri, MD / Pulmonary, Critical Care & Sleep Medicine, Walter Reed Army Medical Center
Walter Reed Army Medical Center
Sunovion
Principal Investigator: Christopher J Lettieri, MD Walter Reed Army Medical Center
Walter Reed Army Medical Center
February 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP