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Sponsors and Collaborators: |
Walter Reed Army Medical Center Sepracor, Inc. |
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Information provided by: | Walter Reed Army Medical Center |
ClinicalTrials.gov Identifier: | NCT00612157 |
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 |
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Obstructive Sleep Apnea |
Drug: Eszopiclone Drug: Placebo control |
Phase IV |
Study Type: | Interventional |
Study Design: | Supportive Care, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study |
Official Title: | Prospective, Randomized, Double-Blind, Placebo-Controlled Trial Assessing the Effect of Eszoplicone on Initial Continuous Positive Airway Pressure (CPAP) Compliance |
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 |
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OSA CPAP: Active Comparator |
Drug: Eszopiclone
Eszopiclone 3mg orally at bedtime for 14 nights
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Placebo: Placebo Comparator |
Drug: Placebo control
Matching placebo
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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.
Ages Eligible for Study: | 18 Years to 64 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, District of Columbia | |
Walter Reed Army Medical Center | |
Washington, District of Columbia, United States, 20307 |
Principal Investigator: | Christopher J Lettieri, MD | Walter Reed Army Medical Center |
Responsible Party: | Walter Reed Army Medical Center ( Christopher J. Lettieri, MD / Pulmonary, Critical Care & Sleep Medicine ) |
Study ID Numbers: | WRAMC07-17022 |
Study First Received: | January 29, 2008 |
Last Updated: | February 25, 2009 |
ClinicalTrials.gov Identifier: | NCT00612157 History of Changes |
Health Authority: | United States: Federal Government |
Obstructive Sleep Apnea Continuous Positive Airway Pressure CPAP Compliance Non-benzodiazepine hypnotics |
Signs and Symptoms Sleep Apnea Syndromes Respiratory Tract Diseases Apnea Respiration Disorders |
Sleep Apnea, Obstructive Dyssomnias Sleep Disorders Signs and Symptoms, Respiratory Sleep Disorders, Intrinsic |
Signs and Symptoms Sleep Apnea Syndromes Respiratory Tract Diseases Apnea Nervous System Diseases Respiration Disorders |
Sleep Apnea, Obstructive Sleep Disorders Dyssomnias Signs and Symptoms, Respiratory Sleep Disorders, Intrinsic |