NCT00811746

Hypnotics to Improve Polysomnography Yield: Eszopiclone vs Ramelteon?

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 90 (estimated)
• Sponsor: Southern California Institute for Research and Education · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Obstructive Sleep Apnea

Interventions

Type	Name	Description
DRUG	Rozerem (Ramelteon)	8 mg taken orally 30 minutes before a split-night PSG
DRUG	Lunesta (Eszopiclone)	3 mg taken orally 30 minutes before the start of a split-night PSG
OTHER	Historical Controls	Chart review matched for demographics and comorbidities of the study drug groups.

Timeline

• Start date: 2008-12-01
• Primary completion: 2010-09-01
• Completion: 2010-10-01
• First posted: 2008-12-19
• Last updated: 2013-05-30

Locations

1 site across 1 country: United States