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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00685269
Recruitment Status : Completed
First Posted : May 28, 2008
Last Update Posted : February 22, 2012
Information provided by (Responsible Party):

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

Condition or disease Intervention/treatment Phase
Obstructive Sleep Apnea Syndrome Drug: Eszopiclone Drug: Placebo Phase 2

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: The Safety and Efficacy of Eszopiclone in Subjects With Mild to Moderate Obstructive Sleep Apnea Syndrome
Study Start Date : August 2003
Actual Primary Completion Date : January 2004
Actual Study Completion Date : January 2004

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sleep Apnea
Drug Information available for: Eszopiclone

Arm Intervention/treatment
Active Comparator: A
eszopiclone 3 mg QD
Drug: Eszopiclone
Eszopiclone 3 mg QD
Other Names:
  • Lunesta
  • (S)-Zopliclone

Placebo Comparator: B
placebo tablet
Drug: Placebo
Placebo tablet

Primary Outcome Measures :
  1. AHI (frequency of apnea and hypopnea episodes). [ Time Frame: Nights -14, 1, 2, 8, 9 ]

Secondary Outcome Measures :
  1. The mean duration of apnea and hypopnea episodes [ Time Frame: Nights -14, 1, 2, 8, 9 ]
  2. Oxygen saturation during apnea and hypopnea [ Time Frame: Nights -14, 1, 2, 8, 9 ]
  3. The number of arousals during apnea and hypopnea [ Time Frame: Nights -14, 1, 2, 8, 9 ]
  4. 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 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   35 Years to 64 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00685269

United States, Georgia
Atlanta, Georgia, United States
United States, Ohio
Cincinnati, Ohio, United States
Sponsors and Collaborators

Responsible Party: Sunovion Identifier: NCT00685269     History of Changes
Other Study ID Numbers: 190-028
First Posted: May 28, 2008    Key Record Dates
Last Update Posted: February 22, 2012
Last Verified: February 2012

Keywords provided by Sunovion:
Obstructive Sleep Apnea Syndrome

Additional relevant MeSH terms:
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Pathologic Processes
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Sleep Disorders, Intrinsic
Sleep Wake Disorders
Nervous System Diseases
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs