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
1 other identifier
interventional
300
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Mar 2007
Shorter than P25 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2007
CompletedFirst Submitted
Initial submission to the registry
July 23, 2007
CompletedFirst Posted
Study publicly available on registry
July 25, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2007
CompletedNovember 30, 2007
October 1, 2007
July 23, 2007
November 29, 2007
Conditions
Keywords
Outcome Measures
Primary Outcomes (7)
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 Outcomes (1)
Respiratory Disturbance Index
during overnight study
Study Arms (1)
PSG
ACTIVE COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Walter Reed Army Medical Centerlead
- Sumitomo Pharma America, Inc.collaborator
Study Sites (1)
Walter Reed Army Medical Center
Washington D.C., District of Columbia, 20307, United States
Related Publications (3)
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.
PMID: 17561625BACKGROUNDLettieri 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.
PMID: 19567493DERIVEDLettieri 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.
PMID: 18788656DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Christopher J Lettieri, MD
Walter Reed Army Medical Center
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- FED
Study Record Dates
First Submitted
July 23, 2007
First Posted
July 25, 2007
Study Start
March 1, 2007
Study Completion
October 1, 2007
Last Updated
November 30, 2007
Record last verified: 2007-10