Hypnotics to Improve Polysomnography Yield: Eszopiclone vs Ramelteon?

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-12-31

Study Completion Date

2010-10-31

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.

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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.

Conditions

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Obstructive Sleep Apnea

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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1

Rozerem (Ramelteon) 8 mg taken orally 30 minutes before a split-night PSG

Group Type EXPERIMENTAL

Rozerem (Ramelteon)

Intervention Type DRUG

8 mg taken orally 30 minutes before a split-night PSG

2

Lunesta (Eszopiclone) 3 mg taken 30 minutes before the start of split-night PSG

Group Type ACTIVE_COMPARATOR

Lunesta (Eszopiclone)

Intervention Type DRUG

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.

Group Type OTHER

Historical Controls

Intervention Type OTHER

Chart review matched for demographics and comorbidities of the study drug groups.

Interventions

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Rozerem (Ramelteon)

8 mg taken orally 30 minutes before a split-night PSG

Intervention Type DRUG

Lunesta (Eszopiclone)

3 mg taken orally 30 minutes before the start of a split-night PSG

Intervention Type DRUG

Historical Controls

Chart review matched for demographics and comorbidities of the study drug groups.

Intervention Type OTHER

Other Intervention Names

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Ramelteon Eszopiclone

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No