Hypnotics to Improve Polysomnography Yield: Eszopiclone vs Ramelteon?
Primary Purpose
Obstructive Sleep Apnea
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Rozerem (Ramelteon)
Lunesta (Eszopiclone)
Historical Controls
Sponsored by
About this trial
This is an interventional diagnostic trial for Obstructive Sleep Apnea focused on measuring obstructive sleep apnea, eszopiclone, ramelteon, polysomnography
Eligibility Criteria
Inclusion Criteria:
- Referred by VA Long Beach Sleep Clinic at their initial evaluation during outpatient consultation for suspect obstructive sleep apnea.
Exclusion Criteria:
- 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
Sites / Locations
- VA Long Beach Healthcare System
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Active Comparator
Other
Arm Label
1
2
3
Arm Description
Rozerem (Ramelteon) 8 mg taken orally 30 minutes before a split-night PSG
Lunesta (Eszopiclone) 3 mg taken 30 minutes before the start of split-night PSG
Historical controls (chart review) matched for demographics and comorbidities of the study drug groups.
Outcomes
Primary Outcome Measures
Non-usable and poor quality PSGs and CPAP intolerance
Secondary Outcome Measures
Full Information
NCT ID
NCT00811746
First Posted
December 17, 2008
Last Updated
May 28, 2013
Sponsor
Southern California Institute for Research and Education
1. Study Identification
Unique Protocol Identification Number
NCT00811746
Brief Title
Hypnotics to Improve Polysomnography Yield: Eszopiclone vs Ramelteon?
Official Title
Hypnotics to Improve Polysomnography Yield: Eszopiclone vs Ramelteon?
Study Type
Interventional
2. Study Status
Record Verification Date
May 2013
Overall Recruitment Status
Completed
Study Start Date
December 2008 (undefined)
Primary Completion Date
September 2010 (Actual)
Study Completion Date
October 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Southern California Institute for Research and Education
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
Detailed Description
Many Veterans suffer from sleep disordered breathing with a high prevalence of undiagnosed obstructive sleep apnea. One test that can be effective in the diagnosis of sleep apnea is the polysomnogram (PSG). Split-night PSG consists of a diagnostic phase in the first half of the night and a continuous positive airway pressure titration (CPAP) in the second half of the night. CPAP is the standard, most effective therapy for obstructive sleep apnea. Due to the unfamiliar sleep environment of the laboratory and instrumentation that must be used (application of electroencephalogram leads), patients are frequently not able to sleep adequately. In these cases, the PSG must be repeated. Oral hypnotic agents are often used as a pre-medication to increase the yield of PSG in an attempt to decrease the need for repeat studies.
Numerous data is available on the effects of premedication with oral short-acting hypnotics on PSG quality and efficacy of CPAP titration. In one study, eszopiclone, a nonbenzodiazepine gaba-receptor agonist short-acting hypnotic, has been shown to improve PSG quality and CPAP titration. Another short-acting hypnotic, ramelteon, was recently approved by FDA but the effects of ramelteon in improving PSG quality and efficacy of CPAP titration are unclear. The advantage of ramelteon over eszopiclone is the lack of drug dependency or abuse potential. This study aims to evaluate the efficacy of ramelteon compared to eszopiclone when administered prior to split-night PSG and CPAP titration.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obstructive Sleep Apnea
Keywords
obstructive sleep apnea, eszopiclone, ramelteon, polysomnography
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
90 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
Rozerem (Ramelteon) 8 mg taken orally 30 minutes before a split-night PSG
Arm Title
2
Arm Type
Active Comparator
Arm Description
Lunesta (Eszopiclone) 3 mg taken 30 minutes before the start of split-night PSG
Arm Title
3
Arm Type
Other
Arm Description
Historical controls (chart review) matched for demographics and comorbidities of the study drug groups.
Intervention Type
Drug
Intervention Name(s)
Rozerem (Ramelteon)
Other Intervention Name(s)
Ramelteon
Intervention Description
8 mg taken orally 30 minutes before a split-night PSG
Intervention Type
Drug
Intervention Name(s)
Lunesta (Eszopiclone)
Other Intervention Name(s)
Eszopiclone
Intervention Description
3 mg taken orally 30 minutes before the start of a split-night PSG
Intervention Type
Other
Intervention Name(s)
Historical Controls
Intervention Description
Chart review matched for demographics and comorbidities of the study drug groups.
Primary Outcome Measure Information:
Title
Non-usable and poor quality PSGs and CPAP intolerance
Time Frame
The morning following the PSG
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Referred by VA Long Beach Sleep Clinic at their initial evaluation during outpatient consultation for suspect obstructive sleep apnea.
Exclusion Criteria:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Catherine S. Sassoon, MD
Organizational Affiliation
VA Long Beach Healthcare System
Official's Role
Principal Investigator
Facility Information:
Facility Name
VA Long Beach Healthcare System
City
Long Beach
State/Province
California
ZIP/Postal Code
90822-5201
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
18788656
Citation
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.
Results Reference
background
Links:
URL
http://www.scire-lb.org/
Description
Southern California Institute for Research and Education Website
Learn more about this trial
Hypnotics to Improve Polysomnography Yield: Eszopiclone vs Ramelteon?
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