Clinical trial NCT00685269: Safety and Efficacy of Eszopiclone With Mild to Moderate Obstructive Sleep Apnea Syndrome (OSAS)
Official title: The Safety and Efficacy of Eszopiclone in Subjects With Mild to Moderate Obstructive Sleep Apnea Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Obstructive Sleep Apnea Syndrome
Keywords: Obstructive Sleep Apnea Syndrome
OSAS
Lead sponsor: Sumitomo Pharma America, Inc.
Sponsor class: INDUSTRY
First posted: 2008-05-28
Enrollment: 20
Sex: ALL
Minimum age (years): 35
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: Inclusion Criteria:

* The subject is capable of understanding and complying with the protocol and has signed the informed consent document, including the privacy authorization. Female subjects of childbearing potential must sign the Women of Childbearing Potential Addendum to the informed consent form.
* Male and female subjects between 35 and 64 years of age, inclusive, with mild to moderate obstructive sleep apnea syndrome (AHI range ≥10 and ≤40).
* Females considered not of childbearing potential must be surgically sterile or greater than one-year post menopausal, defined as a complete cessation of menstruation for at least one year.
* Subjects must use continuous positive airway pressure (CPAP).
* Subjects must be in general good health based on screening physical examination (defined as the absence of any clinically relevant abnormalities), medical history, 12-lead ECG, and clinical laboratory values (hematology, serum chemistry and urinalysis).

Exclusion Criteria:

* Subject has any clinically significant unstable medical abnormality, chronic disease, or a history of a clinically significant abnormality of the cardiovascular, respiratory, hepatic, or renal systems.
* Subject has a history of, or current malignancy except for non melanomatous skin cancer.
* Subject tests positive at screening for hepatitis B surface antigen or hepatitis C antibody, or the subject has a history of a positive result.
* Subject is known to be seropositive for human immunodeficiency virus (HIV).

Primary outcomes:
measure: AHI (frequency of apnea and hypopnea episodes).
timeFrame: Nights -14, 1, 2, 8, 9
Secondary outcomes:
measure: The mean duration of apnea and hypopnea episodes
timeFrame: Nights -14, 1, 2, 8, 9
measure: Oxygen saturation during apnea and hypopnea
timeFrame: Nights -14, 1, 2, 8, 9
measure: The number of arousals during apnea and hypopnea
timeFrame: Nights -14, 1, 2, 8, 9
measure: Objective sleep parameters as measured by PSG (i.e., latency to persistent sleep, sleep efficiency, and wake time after sleep onset
timeFrame: Nights -14, 1, 2, 8, 9
Other outcomes:
Locations:
city: Atlanta
country: United States
state: Georgia
city: Cincinnati
country: United States
state: Ohio
Study officials:
References: