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临床试验/NCT01159652
NCT01159652已完成4 期

Hypnotic Medications and Sleep-dependent Memory Consolidation: the Effect of Variable Drug Exposure During the Night

St. Luke's Hospital, Chesterfield, Missouri1 个研究点 分布在 1 个国家目标入组 26 人开始时间: 2010年10月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
已完成
发起方
入组人数
26
试验地点
1
主要终点
Memory

研究概览

简要总结

The purpose of this study is to determine the effect of two hypnotic medications, zolpidem extended release and zaleplon, on memory. It is expected that a hypnotic with shorter drug duration will allow greater memory consolidation than a hypnotic with longer drug duration.

详细描述

A growing body of evidence has demonstrated that sleep promotes memory consolidation in healthy individuals. However, little research has been conducted regarding the effect of hypnotics on sleep-dependent memory. One study found that zopiclone (7.5 mg), but not brotizolam (0.25 mg), impaired sleep-dependent memory consolidation in normal sleepers. Another study reported significant impairment of sleep-dependent memory on a motor task with triazolam (0.375 mg), but not with zolpidem immediate release (10 mg). These studies provide some evidence that sedative-hypnotic drugs may impair sleep-dependent memory consolidation, but further investigation is clearly needed in this area. Because hypnotics are commonly prescribed for insomnia, it is important to determine if there is a significant risk of impairment in sleep-dependent memory consolidation associated with these medications. Further, investigation of alternative doses and drug regimens upon memory consolidation appears warranted.

The purpose of the current study is to determine the effect of two hypnotic medications on sleep-dependent memory consolidation in normal sleepers. Zolpidem extended release, which will be active for most of the sleep period when administered at bedtime, will be compared to zaleplon, which will be active for half of the sleep period when administered in the middle of the night. This comparison allows us to address the question of whether a few hours of drug-free sleep results in better memory consolidation than sleep with drug throughout the night.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Basic Science
盲法
Double (Participant, Care Provider)

入排标准

年龄范围
18 Years 至 50 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • 18 to 50 years of age
  • no sleep complaints or problems
  • good sleep quality per questionnaire
  • sufficient time in bed each night

排除标准

  • any clinically significant unstable medical condition
  • recent psychiatric disorder
  • prior diagnosis or symptoms of a sleep disorder
  • recent history of substance abuse
  • recent use of prescription hypnotic medication or over-the-counter sleep aid
  • recent use of psychotropic medication
  • history of adverse reaction to benzodiazepines
  • body mass index > 36
  • currently pregnant or nursing
  • currently working rotating or night shift
  • consumption of > 700 mg per day of xanthine-containing food or beverages
  • consumption of > 14 units of alcohol per week
  • smoke > 1 pack of cigarettes per day, use of chewing tobacco more than 3 times per day, or unable to refrain from smoking or chewing without distress or discomfort while in the sleep laboratory

研究组 & 干预措施

Bedtime Placebo

Placebo Comparator

干预措施: bedtime placebo (Drug)

Middle of the Night Placebo

Placebo Comparator

干预措施: middle of the night placebo (Drug)

Zolpidem

Experimental

干预措施: zolpidem extended release (Drug)

Zaleplon

Experimental

干预措施: zaleplon (Drug)

结局指标

主要结局

Memory

时间窗: 8 timepoints: 4 evenings and 4 mornings

Two memory tasks will be used to assess memory.

次要结局

未报告次要终点

研究者

发起方
St. Luke's Hospital, Chesterfield, Missouri
申办方类型
Other
责任方
Sponsor

研究点 (1)

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