NCT00507117

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 300 (estimated)
• Sponsor: Walter Reed Army Medical Center · Federal
• Sex: All
• Age: 18 Years – 64 Years
• Healthy volunteers: Accepted

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.

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.

Conditions

• Obstructive Sleep Apnea

Interventions

Type	Name	Description
DRUG	Lunesta	Lunesta 3mg prior to PSG
DRUG	Placebo control	matching placebo

Timeline

• Start date: 2007-03-01
• Completion: 2007-10-01
• First posted: 2007-07-25
• Last updated: 2007-11-30

Locations

1 site across 1 country: United States