Hypnotics to Improve Polysomnography Yield: Eszopiclone vs Ramelteon?
1 other identifier
interventional
90
1 country
1
Brief Summary
This study is being conducted to determine if eszopiclone is as effective as ramelteon when used as a pre-medication (sleeping pill) in sleep studies performed to diagnose and treat sleep apnea.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Dec 2008
Typical duration for not_applicable
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
December 1, 2008
CompletedFirst Submitted
Initial submission to the registry
December 17, 2008
CompletedFirst Posted
Study publicly available on registry
December 19, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2010
CompletedMay 30, 2013
May 1, 2013
1.8 years
December 17, 2008
May 28, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Non-usable and poor quality PSGs and CPAP intolerance
The morning following the PSG
Study Arms (3)
1
EXPERIMENTALRozerem (Ramelteon) 8 mg taken orally 30 minutes before a split-night PSG
2
ACTIVE COMPARATORLunesta (Eszopiclone) 3 mg taken 30 minutes before the start of split-night PSG
3
OTHERHistorical controls (chart review) matched for demographics and comorbidities of the study drug groups.
Interventions
8 mg taken orally 30 minutes before a split-night PSG
3 mg taken orally 30 minutes before the start of a split-night PSG
Chart review matched for demographics and comorbidities of the study drug groups.
Eligibility Criteria
You may qualify if:
- Referred by VA Long Beach Sleep Clinic at their initial evaluation during outpatient consultation for suspect obstructive sleep apnea.
You may not qualify if:
- Sleep disorders other than obstructive sleep apnea
- No prior PSG
- Uncontrolled medical condition
- Prior known adverse reaction to eszopiclone or ramelteon
- Liver disfunction
- Current alcohol abuser
- Current illicit drug abuser
- Alcohol consumption 12 hours prior to polysomnography
- Decompensated psychiatric disorders
- Severe dementia
- Concomitant use of benzodiazepines, trazodone, narcotics, barbiturates or other medications with sedative or hypnotic effects
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
VA Long Beach Healthcare System
Long Beach, California, 90822-5201, United States
Related Publications (1)
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.
PMID: 18788656BACKGROUND
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Catherine S. Sassoon, MD
VA Long Beach Healthcare System
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Staff Physician, Pricipal Investigator
Study Record Dates
First Submitted
December 17, 2008
First Posted
December 19, 2008
Study Start
December 1, 2008
Primary Completion
September 1, 2010
Study Completion
October 1, 2010
Last Updated
May 30, 2013
Record last verified: 2013-05