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

Study Overview
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Brief Summary
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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).

Detailed Description
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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.

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

Conditions
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Obstructive Sleep Apnea

Intervention / Treatment
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* Drug: Eszopiclone
* Drug: Placebo control


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 64 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: OSA CPAP<br> | Drug: Eszopiclone<br>* Eszopiclone 3mg orally at bedtime for 14 nights<br>* Other names: Lunesta;|
| Placebo Comparator: Placebo<br> | Drug: Placebo control<br>* Matching placebo<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Short term CPAP Compliance |  | 3 months | 
| Intermediate CPAP Compliance |  | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of Life Issue - Prostate Symptoms for men |  | 1 month, 3 months, 6 months, 9 months, 12 months | 
| Quality of Life Issue - Erectile Dysfunction for men |  | 1 month, 3 months, 6 months, 9 months, 12 months | 
| Quality of Life Issue - Sleepiness |  | 1 month, 3 months, 6 months, 9 months, 12 months | 
| Quality of Life Issue - Fatigue |  | 1 month, 3 months, 6 months, 9 months, 12 months | 
| Quality of Life Issue - Subjective Sleep Quality |  | 1 month, 3 months, 6 months, 9 months, 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Obstructive Sleep Apnea, Continuous Positive Airway Pressure, CPAP Compliance, Non-benzodiazepine hypnotics