Ezopiclone Improves the Quality of Overnight Polysomnography
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|ClinicalTrials.gov Identifier: NCT00507117|
Recruitment Status : Completed
First Posted : July 25, 2007
Last Update Posted : November 30, 2007
|Condition or disease||Intervention/treatment||Phase|
|Obstructive Sleep Apnea||Drug: Lunesta Drug: Placebo control||Phase 4|
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|
|Intervention Model:||Parallel Assignment|
|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|
|Active Comparator: PSG||
Lunesta 3mg prior to PSG
Drug: Placebo control
- 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 ]
- Respiratory Disturbance Index [ Time Frame: during overnight study ]
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 ClinicalTrials.gov identifier (NCT number): NCT00507117
|United States, District of Columbia|
|Walter Reed Army Medical Center|
|Washington DC, District of Columbia, United States, 20307|
|Principal Investigator:||Christopher J Lettieri, MD||Walter Reed Army Medical Center|