Ezopiclone Improves the Quality of Overnight Polysomnography
Information source: Walter Reed Army Medical Center
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Obstructive Sleep Apnea
Intervention: Lunesta (Drug); Placebo control (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: Walter Reed Army Medical Center Official(s) and/or principal investigator(s): Christopher J Lettieri, MD, Principal Investigator, Affiliation: Walter Reed Army Medical Center
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.
Clinical Details
Official title: Prospective, Randomized, Placebo Controlled Trial Assessing the Effects of Ezopiclone on the Quality of Overnight Polysomnography and CPAP Titration
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Diagnostic
Primary outcome: diagnostic yield of PSGtotal sleep time wake after sleep onset sleep latency sleep efficiency total arousal index respiratory disturbance index at highest CPAP level
Secondary outcome: Respiratory Disturbance Index
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.
Eligibility
Minimum age: 18 Years.
Maximum age: 64 Years.
Gender(s): Both.
Criteria:
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
Locations and Contacts
Walter Reed Army Medical Center, Washington DC, District of Columbia 20307, United States
Additional Information
Related publications: Lettieri CJ, Eliasson AH, Andrada T, Khramtsov A, Kristo DA. Does zolpidem enhance the yield of polysomnography? J Clin Sleep Med. 2005 Apr 15;1(2):129-31.
Starting date: March 2007
Last updated: November 29, 2007
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