NCT00685269

Safety and Efficacy of Eszopiclone With Mild to Moderate Obstructive Sleep Apnea Syndrome (OSAS)

The Safety and Efficacy of Eszopiclone in Subjects With Mild to Moderate Obstructive Sleep Apnea Syndrome

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Sumitomo Pharma America, Inc. · Industry
• Sex: All
• Age: 35 Years – 64 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the hypnotic efficacy of ezopiclone in subjects with mild to moderate OSAS.

Detailed description

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.

Conditions

• Obstructive Sleep Apnea Syndrome

Interventions

Type	Name	Description
DRUG	Eszopiclone	Eszopiclone 3 mg QD
DRUG	Placebo	Placebo tablet

Timeline

• Start date: 2003-08-01
• Primary completion: 2004-01-01
• Completion: 2004-01-01
• First posted: 2008-05-28
• Last updated: 2012-02-22

Locations

2 sites across 1 country: United States