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.

Study Overview

• Status: Completed
• Conditions: Obstructive Sleep Apnea
• Intervention / Treatment: Drug: Lunesta; Drug: Placebo control

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
• Enrollment (Anticipated): 300
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • District of Columbia
    • Washington DC, District of Columbia, United States, 20307
      • Walter Reed Army Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 64 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: PSG	Drug: Lunesta; Lunesta 3mg prior to PSG; Drug: Placebo control; matching placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
diagnostic yield of PSG	during overnight study
total sleep time	during overnight study
wake after sleep onset	during overnight study
sleep latency	during overnight study
sleep efficiency	during overnight study
total arousal index	during overnight study
respiratory disturbance index at highest CPAP level	during overnight study

Secondary Outcome Measures

Outcome Measure	Time Frame
Respiratory Disturbance Index	during overnight study

Collaborators and Investigators

• Sponsor: Walter Reed Army Medical Center
• Collaborators: Sunovion
• Investigators: Principal Investigator: Christopher J Lettieri, MD, Walter Reed Army Medical Center

Publications and helpful links

General 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.
• Lettieri CJ, Collen JF, Eliasson AH, Quast TM. Sedative use during continuous positive airway pressure titration improves subsequent compliance: a randomized, double-blind, placebo-controlled trial. Chest. 2009 Nov;136(5):1263-1268. doi: 10.1378/chest.09-0811. Epub 2009 Jun 30.
• Lettieri CJ, Quast TN, Eliasson AH, Andrada T. Eszopiclone improves overnight polysomnography and continuous positive airway pressure titration: a prospective, randomized, placebo-controlled trial. Sleep. 2008 Sep;31(9):1310-6.

Study record dates

Study Major Dates

• Study Start: March 1, 2007
• Study Completion (Actual): October 1, 2007

Study Registration Dates

• First Submitted: July 23, 2007
• First Submitted That Met QC Criteria: July 24, 2007
• First Posted (Estimate): July 25, 2007

Study Record Updates

• Last Update Posted (Estimate): November 30, 2007
• Last Update Submitted That Met QC Criteria: November 29, 2007
• Last Verified: October 1, 2007

More Information

Terms related to this study

• Keywords: Obstructive Sleep Apnea; Polysomnography; Non-benzodiazepine hypnotics
• Additional Relevant MeSH Terms: Nervous System Diseases; Respiratory Tract Diseases; Apnea; Respiration Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Sleep Apnea Syndromes; Sleep Apnea, Obstructive; Physiological Effects of Drugs; Central Nervous System Depressants; Hypnotics and Sedatives; Eszopiclone
• Other Study ID Numbers: WRAMC05-17017