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| Sponsor: | Southern California Institute for Research and Education |
|---|---|
| Information provided by: | Southern California Institute for Research and Education |
| ClinicalTrials.gov Identifier: | NCT00811746 |
Purpose
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.
| Condition | Intervention |
|---|---|
|
Obstructive Sleep Apnea |
Drug: Rozerem (Ramelteon) Drug: Lunesta (Eszopiclone) Other: Historical Controls |
| Study Type: | Interventional |
| Study Design: | Diagnostic, Randomized, Double Blind (Subject, Investigator), Historical Control, Parallel Assignment, Safety/Efficacy Study |
| Official Title: | Hypnotics to Improve Polysomnography Yield: Eszopiclone vs Ramelteon? |
| Estimated Enrollment: | 90 |
| Study Start Date: | December 2008 |
| Estimated Study Completion Date: | September 2010 |
| Estimated Primary Completion Date: | September 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
1: Experimental
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
|
|
2: Active Comparator
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
|
|
3
Historical controls (chart review) matched for demographics and comorbidities of the study drug groups.
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Other: Historical Controls
Chart review matched for demographics and comorbidities of the study drug groups.
|
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.
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Catherine S. Sassoon, MD | (562) 826-5839 | catherine.sassoon@va.gov |
| Contact: Sterling Malish, MD | (562) 826-8000 ext 4921 | smalish@uci.edu |
| United States, California | |
| VA Long Beach Healthcare System | Recruiting |
| Long Beach, California, United States, 90822-5201 | |
| Principal Investigator: Catherine S. Sassoon, MD | |
| Sub-Investigator: Sterling Malish, MD | |
| Principal Investigator: | Catherine S. Sassoon, MD | VA Long Beach Healthcare System |
More Information
| Responsible Party: | VA Long Beach Healthcare System ( Catherine S. Sassoon, M.D. ) |
| Study ID Numbers: | #924 |
| Study First Received: | December 17, 2008 |
| Last Updated: | January 13, 2010 |
| ClinicalTrials.gov Identifier: | NCT00811746 History of Changes |
| Health Authority: | United States: Institutional Review Board |
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obstructive sleep apnea eszopiclone ramelteon polysomnography |
|
Sleep Apnea Syndromes Apnea Sleep Apnea, Obstructive Respiration Disorders Nervous System Diseases Physiological Effects of Drugs Dyssomnias Sleep Disorders |
Central Nervous System Depressants Pharmacologic Actions Sleep Disorders, Intrinsic Respiratory Tract Diseases Therapeutic Uses Hypnotics and Sedatives Central Nervous System Agents |