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Ezopiclone Improves the Quality of Overnight Polysomnography
This study has been completed.
Study NCT00507117   Information provided by Walter Reed Army Medical Center
First Received: July 23, 2007   Last Updated: November 29, 2007   History of Changes

July 23, 2007
November 29, 2007
March 2007
 
  • diagnostic yield of PSG [ Time Frame: during overnight study ]
  • total sleep time [ Time Frame: during overnight study ]
  • wake after sleep onset [ Time Frame: during overnight study ]
  • sleep latency [ Time Frame: during overnight study ]
  • sleep efficiency [ Time Frame: during overnight study ]
  • total arousal index [ Time Frame: during overnight study ]
  • respiratory disturbance index at highest CPAP level [ Time Frame: during overnight study ]
Same as current
Complete list of historical versions of study NCT00507117 on ClinicalTrials.gov Archive Site
Respiratory Disturbance Index [ Time Frame: during overnight study ]
Same as current
 
Ezopiclone Improves the Quality of Overnight Polysomnography
Prospective, Randomized, Placebo Controlled Trial Assessing the Effects of Ezopiclone on the Quality of Overnight Polysomnography and CPAP Titration

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.

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.

Phase IV
Interventional
Diagnostic, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study
Obstructive Sleep Apnea
  • Drug: Lunesta
  • Drug: Placebo control
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Completed
300
October 2007
 

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
Both
18 Years to 64 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00507117
 
WRAMC05-17017
Walter Reed Army Medical Center
Sepracor, Inc.
Principal Investigator: Christopher J Lettieri, MD Walter Reed Army Medical Center
Walter Reed Army Medical Center
October 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP