Hypnotics to Improve Polysomnography Yield: Eszopiclone vs Ramelteon?
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|ClinicalTrials.gov Identifier: NCT00811746|
Recruitment Status : Completed
First Posted : December 19, 2008
Last Update Posted : May 30, 2013
|Condition or disease||Intervention/treatment||Phase|
|Obstructive Sleep Apnea||Drug: Rozerem (Ramelteon) Drug: Lunesta (Eszopiclone) Other: Historical Controls||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||90 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||Hypnotics to Improve Polysomnography Yield: Eszopiclone vs Ramelteon?|
|Study Start Date :||December 2008|
|Actual Primary Completion Date :||September 2010|
|Actual Study Completion Date :||October 2010|
Rozerem (Ramelteon) 8 mg taken orally 30 minutes before a split-night PSG
Drug: Rozerem (Ramelteon)
8 mg taken orally 30 minutes before a split-night PSG
Other Name: Ramelteon
Active Comparator: 2
Lunesta (Eszopiclone) 3 mg taken 30 minutes before the start of split-night PSG
Drug: Lunesta (Eszopiclone)
3 mg taken orally 30 minutes before the start of a split-night PSG
Other Name: Eszopiclone
Historical controls (chart review) matched for demographics and comorbidities of the study drug groups.
Other: Historical Controls
Chart review matched for demographics and comorbidities of the study drug groups.
- Non-usable and poor quality PSGs and CPAP intolerance [ Time Frame: The morning following the PSG ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00811746
|United States, California|
|VA Long Beach Healthcare System|
|Long Beach, California, United States, 90822-5201|
|Principal Investigator:||Catherine S. Sassoon, MD||VA Long Beach Healthcare System|