Obstructive Sleep Apnea
Conditions
Keywords
Obstructive Sleep Apnea, Continuous Positive Airway Pressure, CPAP Compliance, Non-benzodiazepine hypnotics
Brief summary
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
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.
Interventions
DRUGEszopiclone
Eszopiclone 3mg orally at bedtime for 14 nights
DRUGPlacebo control
Matching placebo
Sponsors
Sumitomo Pharma America, Inc.
Walter Reed Army Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 64 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Short term CPAP Compliance | 3 months |
| Intermediate CPAP Compliance | 1 year |
Secondary
| Measure | Time frame |
|---|---|
| Quality of Life Issue - Sleepiness | 1 month, 3 months, 6 months, 9 months, 12 months |
| Quality of Life Issue - Prostate Symptoms for men | 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 |
| Quality of Life Issue - Fatigue | 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 |
Countries
United States
Outcome results
None listed