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临床试验/NCT04211506
NCT04211506已完成不适用

Comparison Across Multiple Types of Sleep Deprivation

Civil Aerospace Medical Institute4 个研究点 分布在 1 个国家目标入组 59 人开始时间: 2020年8月25日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
59
试验地点
4
主要终点
Gene expression changes associated with different sleep patterns.

研究概览

简要总结

This study is designed to assess neurobehavioral performance, as well as genetic and other physiological changes associated with variations in timing and quantity of sleep.

详细描述

During a 1.5 week inpatient laboratory protocol, subjects will undergo one of four parallel sleep conditions. Subjects will be randomly assigned to each condition group. During their time in the laboratory, biological samples (e.g., blood) will be collected for genetic and other analyses, and sleep quantity and quality will be monitored. Additionally responses on neurobehavioral tests and surveys will be monitored for differences among the groups.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
Single (Participant)

盲法说明

Participants may not know to which study arm they are assigned.

入排标准

年龄范围
20 Years 至 45 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • BMI 18.5-29.9, with consideration of BMIs 30-34.9.

排除标准

  • Medication use, with potential consideration for contraceptives.
  • Color blindness
  • Recent nightwork, shiftwork, or travel across greater than two time zones
  • Pregnant or within 6 months post-partum

结局指标

主要结局

Gene expression changes associated with different sleep patterns.

时间窗: Samples for gene expression will be collected at frequent intervals over 10 days in a sleep laboratory. Subjects will be in a time-free environment, and not told sampling frequency.

Levels of expression of all genes may be compared across time and among study arms with different sleep patterns using RNA-Seq and differential expression analysis with generalized linear models. Patterns may be sought with and potential relevance to sleep, circadian rhythms, and/or neurobehavioral performance.

次要结局

  • Neurobehavioral performance changes associated with different sleep patterns.(Neurobehavioral assays may be conducted at frequent intervals over 10 days in a sleep laboratory. Subjects will be in a time-free environment, and not told assay frequency.)
  • DNA genetic variants associated with sleep and/or neurobehavioral performance.(Approximately two oral samples may be taken for DNA analyses during the 10 days in a sleep laboratory.)

研究者

发起方
Civil Aerospace Medical Institute
申办方类型
Fed
责任方
Sponsor

研究点 (4)

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