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临床试验/NCT00811746
NCT00811746已完成不适用

Hypnotics to Improve Polysomnography Yield: Eszopiclone vs Ramelteon?

Southern California Institute for Research and Education1 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2008年12月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
90
试验地点
1
主要终点
Non-usable and poor quality PSGs and CPAP intolerance

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Diagnostic
盲法
Double (Participant, Investigator)

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Referred by VA Long Beach Sleep Clinic at their initial evaluation during outpatient consultation for suspect obstructive sleep apnea.

排除标准

  • 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

研究组 & 干预措施

1

Experimental

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

干预措施: Rozerem (Ramelteon) (Drug)

2

Active Comparator

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

干预措施: Lunesta (Eszopiclone) (Drug)

3

Other

Historical controls (chart review) matched for demographics and comorbidities of the study drug groups.

干预措施: Historical Controls (Other)

结局指标

主要结局

Non-usable and poor quality PSGs and CPAP intolerance

时间窗: The morning following the PSG

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Catherine_Sassoon

Staff Physician, Pricipal Investigator

Southern California Institute for Research and Education

研究点 (1)

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