Hypnotics to Improve Polysomnography Yield: Eszopiclone vs Ramelteon?

Study Overview
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Brief Summary
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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
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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.

Official Title
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Hypnotics to Improve Polysomnography Yield: Eszopiclone vs Ramelteon?

Conditions
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Obstructive Sleep Apnea

Intervention / Treatment
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* Drug: Rozerem (Ramelteon)
* Drug: Lunesta (Eszopiclone)
* Other: Historical Controls


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Rozerem (Ramelteon) 8 mg taken orally 30 minutes before a split-night PSG | Drug: Rozerem (Ramelteon)<br>* 8 mg taken orally 30 minutes before a split-night PSG<br>* Other names: Ramelteon;|
| Active Comparator: 2<br>Lunesta (Eszopiclone) 3 mg taken 30 minutes before the start of split-night PSG | Drug: Lunesta (Eszopiclone)<br>* 3 mg taken orally 30 minutes before the start of a split-night PSG<br>* Other names: Eszopiclone;|
| Other: 3<br>Historical controls (chart review) matched for demographics and comorbidities of the study drug groups. | Other: Historical Controls<br>* Chart review matched for demographics and comorbidities of the study drug groups.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Non-usable and poor quality PSGs and CPAP intolerance |  | The morning following the PSG | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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obstructive sleep apnea, eszopiclone, ramelteon, polysomnography