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OpenTrials
Completed

NCT Number: NCT00811746

Hypnotics to Improve Polysomnography Yield: Eszopiclone vs Ramelteon?

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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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

VA Long Beach Healthcare System

Long Beach, California, 90822-5201, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Rozerem (Ramelteon)

Drug

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

Other names: Ramelteon

Lunesta (Eszopiclone)

Drug

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

Other names: Eszopiclone

Historical controls

Other

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

Primary outcomes

  1. Non-usable and poor quality PSGs and CPAP intolerance

    Time frame: The morning following the PSG

Sponsors and collaborators

Lead sponsor

Southern California Institute for Research and Education

Other

Registry information

Important dates

Study start
2008
Primary completion
2010
Study completion
2010
First posted
Dec 19, 2008
Registry last updated
May 30, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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