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临床试验/NCT01493661
NCT01493661已完成不适用

Chronic Sleep Restriction: Neurobehavioral and Physiological Responses

Federal University of São Paulo1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2011年12月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
20
试验地点
1

研究概览

简要总结

Sleep is a physiological state considered essential for health and human survival. The prevalence of chronic sleep restriction has increased in modern society, as well as the effects of the same health concerns about various aspects, including the physiological and neurobehavioral. The objective of this study is to identify the neurobehavioral and physiological responses of healthy men with different needs of total sleep time (TST) submitted to chronic sleep restriction. Participants in this study will be 30 male volunteers, aged between 20 and 35 years, divided into three groups: Group 1 (n = 10) with TST ≤ 6 hours (h), Group 2 (n = 10) with TST ≥ 9h and Group 3 (n = 10): TST with between 7 and 8h. The TST will be established by the constant and continuous use of actigraphy for 10 days prior to the onset of the experimental protocol. All volunteers will undergo medical and polysomnography (PSG) examination to detect the presence or not of changes in sleep as well as other health problem that prevents their participation in the study. The experimental protocol consists of a basal night of sleep, five consecutive nights of chronic sleep restriction to 25% of TST in the beginning night and a night of recovery, which will be allowed to sleep the sleep pattern. Each night will have PSG monitoring and when wake up in each day, the volunteer will undergo tests to assess the physiological and neurobehavioral variables. The significance level will be 5% (p ≤ 0.05).

研究设计

研究类型
Observational
时间视角
Cross Sectional

入排标准

年龄范围
20 Years 至 35 Years(Adult)
性别
Male
接受健康志愿者

入选标准

  • Body Mass Index ≤ 25 kg/m2
  • Physically active individuals
  • 8 years of school education.

排除标准

  • High level of anxiety - State-Trait Anxiety Inventory (STAI-T) ≥ 35
  • High level of anxiety - Beck Depression Inventory ≥ 19
  • PSQI - Pittsburgh Sleep Quality Index ≥ 11
  • ESS - Epworth Sleepiness Scale ≥ 15
  • Irregular rhythm of sleep identified by actigraphy
  • Sleep disturbance by polysomnography
  • Shift worker or nocturnal worker;
  • Alcohol Intake of more than 3 drinks per day;
  • Taking sleep medications or illicit drugs.

研究者

发起方
Federal University of São Paulo
申办方类型
Other
责任方
Principal Investigator
主要研究者

Marco Tulio de Mello

Ph.D

Federal University of São Paulo

研究点 (1)

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