Ezopiclone Improves the Quality of Overnight Polysomnography

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: NCT00507117
Recruitment Status : Completed
First Posted : July 25, 2007
Last Update Posted : November 30, 2007
Information provided by:
Walter Reed Army Medical Center

Brief Summary:
Patients often have difficulty sleeping during overnight sleep testing in a lab environment. The purpose of this study is to determine if taking a sleep aid will improve sleep and therefore the quality of the sleep study.

Condition or disease Intervention/treatment Phase
Obstructive Sleep Apnea Drug: Lunesta Drug: Placebo control Phase 4

Detailed Description:

The increasing awareness of sleep-disordered breathing (i.e obstructive sleep apnea) has created a growing demand for polysomnography (sleep study), resulting in excessive waiting times in many laboratories. Sleep centers have therefore needed to develop methods to improve their efficiency. Unfortunately many patients find it difficult to fall asleep in the unfamiliar environment of a laboratory setting (the "first-night effect"), circumstances that may prolong falling alseep and staying sleep. Likewise, intolerance of continuous positive airway pressure (CPAP) may also reduce the quality of the sleep study. Poor quality studies may lead to an inability to make a diagnosis or adequately titrate CPAP therapy. Unsatisfactory studies may need to be repeated.

Sleep aids (hypnotics) are commonly used to treat both acute and chronic insomnia. These agents have minimal side-effects and do not disrupt normal sleep architecture or alter respiratory events. These attributes make such agents ideal for use to improve the quality of sleep studies and enhance the efficiency of sleep centers.

In a recent retrospective review, we found that the use of a hypnotic prior to the sleep study resulted improved patient satisfaction and improved quality of the sleep study with significantly less studies needing to be repeated. Although promising, these results must be validated with a prospective, randomized, placebo-controlled trial.

Eszopiclone (Lunesta) is a new non-narcotic, non-benzodiazepine hypnotic agent which received FDA approval on December 15, 2004 for the treatment of acute and chronic insomnia. Multiple clinical trials have found that eszopiclone decreases sleep latency, improves sleep efficiency/maintenance and reduces wake time after sleep onset (WASO). Given its efficacy in promoting sleep onset and sleep maintenance and its excellent safety profile, this agent should be ideal as a pre-study sedative. The purpose of this study is to validate the use of Lunesta in improving the quality of overnight sleep studies.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Diagnostic
Official Title: Prospective, Randomized, Placebo Controlled Trial Assessing the Effects of Ezopiclone on the Quality of Overnight Polysomnography and CPAP Titration
Study Start Date : March 2007
Actual Study Completion Date : October 2007

Resource links provided by the National Library of Medicine

Drug Information available for: Eszopiclone

Arm Intervention/treatment
Active Comparator: PSG Drug: Lunesta
Lunesta 3mg prior to PSG

Drug: Placebo control
matching placebo

Primary Outcome Measures :
  1. diagnostic yield of PSG [ Time Frame: during overnight study ]
  2. total sleep time [ Time Frame: during overnight study ]
  3. wake after sleep onset [ Time Frame: during overnight study ]
  4. sleep latency [ Time Frame: during overnight study ]
  5. sleep efficiency [ Time Frame: during overnight study ]
  6. total arousal index [ Time Frame: during overnight study ]
  7. respiratory disturbance index at highest CPAP level [ Time Frame: during overnight study ]

Secondary Outcome Measures :
  1. Respiratory Disturbance Index [ Time Frame: during overnight study ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 64 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • All adult patients aged 18-65, evaluated by a sleep medicine provider in the Walter Reed Army Medical Center Sleep Disorders Clinic, who are referred for PSG for suspected Obstructive Sleep Apnea Syndrome

Exclusion Criteria:

  • Pregnancy
  • Liver dysfunction or history of EtOH abuse
  • Concomitant use of benzodiazepines, narcotics or ketozonazole
  • Decompensated CHF
  • CVA within 3 months
  • Uncontrolled psychiatric disorders
  • Patients < 18 years old
  • Patients over 65

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): NCT00507117

United States, District of Columbia
Walter Reed Army Medical Center
Washington DC, District of Columbia, United States, 20307
Sponsors and Collaborators
Walter Reed Army Medical Center
Principal Investigator: Christopher J Lettieri, MD Walter Reed Army Medical Center

Publications automatically indexed to this study by Identifier (NCT Number): Identifier: NCT00507117     History of Changes
Other Study ID Numbers: WRAMC05-17017
First Posted: July 25, 2007    Key Record Dates
Last Update Posted: November 30, 2007
Last Verified: October 2007

Keywords provided by Walter Reed Army Medical Center:
Obstructive Sleep Apnea
Non-benzodiazepine hypnotics

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