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
  Purpose

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 Intervention Phase
Obstructive Sleep Apnea
Drug: Eszopiclone
Drug: Placebo control
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


Further study details as provided by Walter Reed Army Medical Center:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 154
Study Start Date: January 2008
Study Completion Date: February 2009
Primary Completion Date: June 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 64 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00612157

Locations
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
Sunovion
Investigators
Principal Investigator: Christopher J Lettieri, MD Walter Reed Army Medical Center
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Christopher J. Lettieri, MD / Pulmonary, Critical Care & Sleep Medicine, Walter Reed Army Medical Center
ClinicalTrials.gov Identifier: NCT00612157     History of Changes
Other Study ID Numbers: WRAMC07-17022
Study First Received: January 29, 2008
Last Updated: February 25, 2009
Health Authority: United States: Federal Government

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

Additional relevant MeSH terms:
Apnea
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Dyssomnias
Nervous System Diseases
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms
Signs and Symptoms, Respiratory
Sleep Disorders
Sleep Disorders, Intrinsic
Eszopiclone
Central Nervous System Agents
Central Nervous System Depressants
Hypnotics and Sedatives
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on October 21, 2014