Ezopiclone Improves the Quality of Overnight Polysomnography

Obstructive Sleep Apnea Clinical Trial

Official title:

Prospective, Randomized, Placebo Controlled Trial Assessing the Effects of Ezopiclone on the Quality of Overnight Polysomnography and CPAP Titration

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00507117
• Other study ID #: WRAMC05-17017
• Status: Completed
• Phase: Phase 4
• First received: July 23, 2007
• Last updated: November 29, 2007
• Start date: March 2007
• Est. completion date: October 2007

Study information

• Verified date: October 2007
• Source: Walter Reed Army Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 300
• Est. completion date: October 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 64 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Obstructive Sleep Apnea
• Sleep Apnea, Obstructive

Intervention

Drug:
• Lunesta
Lunesta 3mg prior to PSG
• Placebo control
matching placebo

Locations

Country	Name	City	State
United States	Walter Reed Army Medical Center	Washington DC	District of Columbia

Sponsors (2)

Lead Sponsor	Collaborator
Walter Reed Army Medical Center	Sunovion

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	diagnostic yield of PSG		during overnight study
Primary	total sleep time		during overnight study
Primary	wake after sleep onset		during overnight study
Primary	sleep latency		during overnight study
Primary	sleep efficiency		during overnight study
Primary	total arousal index		during overnight study
Primary	respiratory disturbance index at highest CPAP level		during overnight study
Secondary	Respiratory Disturbance Index		during overnight study