The purpose of this study is to evaluate the hypnotic efficacy of ezopiclone in subjects with mild to moderate OSAS.
Sleep apnea is a sleep disorder characterized by pauses in breathing during sleep. This study will compare the use of eszopiclone to placebo for subjects with mild to moderate obstructive sleep Apnea syndrome (OSAS). Frequency and duration of apnea and hypopnea episodes, oxygen saturation, objective sleep parameters and safety information will be collected in this study. This study was previously posted by Sepracor Inc. In October 2009, Sepracor Inc. was acquired by Dainippon Sumitomo Pharma., and in October 2010, Sepracor Inc's name was changed to Sunovion Pharmaceuticals Inc.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
20
Eszopiclone 3 mg QD
Placebo tablet
Unnamed facility
Atlanta, Georgia, United States
Unnamed facility
Cincinnati, Ohio, United States
AHI (frequency of apnea and hypopnea episodes).
Time frame: Nights -14, 1, 2, 8, 9
The mean duration of apnea and hypopnea episodes
Time frame: Nights -14, 1, 2, 8, 9
Oxygen saturation during apnea and hypopnea
Time frame: Nights -14, 1, 2, 8, 9
The number of arousals during apnea and hypopnea
Time frame: Nights -14, 1, 2, 8, 9
Objective sleep parameters as measured by PSG (i.e., latency to persistent sleep, sleep efficiency, and wake time after sleep onset
Time frame: Nights -14, 1, 2, 8, 9
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