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临床试验/NCT00804804
NCT00804804已完成不适用

Aging,Sleep and Cognitive Process

University Hospital, Bordeaux6 个研究点 分布在 1 个国家目标入组 28 人开始时间: 2008年12月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
28
试验地点
6
主要终点
Executive functions will be evaluated by a Go/NoGo task and a Stop Signal. Performances will be measured with a visual simple reaction time task

研究概览

简要总结

The aim of the study is to determine the impact of aging, circadian rhythms and sleep deprivation on executive performances. Volunteers will complete a 40-hour extended wakefulness period in constant condition (semi-recumbent posture in bed, constant dim light levels < 10 lux, food and liquid intake at regular intervals) in order to control the circadian system. The volunteers will not be allowed to sleep in the sleep deprivation protocol ("high sleep pressure protocol") and will adopt a short wakefulness/sleep cycle (150/75 minutes) in the multiple nap protocol ("low sleep pressure protocol"). Tests and scales will be repeated every 3H45

详细描述

Social evolutions (nocturnal activity, shift work) have consequently reduced average sleep duration average. In addition, aging leads to a physiological reduction of nocturnal sleep duration.

Many studies have shown that extended wakefulness impairs nocturnal performances measured with a simple reaction time test (SRTT) and that this decrement is also age-related. In deed, young subjects (20-30 years) are more affected than old subjects (50-60 years) during an extended wakefulness period.

The results obtained in confinement constant conditions, associated to a high or low sleep pressure, show that this difference observed between young and old subjects should be essentially related to a reduced circadian regulation (ex : reduced melatonin secretion) with age rather than to a reduced sleep pressure (homeostatic regulation) as previously suggested. However, studies on confinement have shown that sleep pressure (identified during the sleep period with the EEG delta band) could be reduced with aging specifically on the anterior brain regions (frontal regions).

It is well-known that executive performances (related to frontal lobes functioning) are affected by extended wakefulness, but respective effects of age, circadian system and sleep pressure in this decrement remain unknown.

The aim of this study is to determine the evolution of the executive functions during a 40-hour extended wakefulness period ("high sleep pressure protocol") or during a multiple nap protocol ("low sleep pressure protocol") according to the subjects' age, in constant experimental conditions of confinement.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Basic Science
盲法
None

入排标准

年龄范围
20 Years 至 75 Years(Adult, Older Adult)
性别
Male
接受健康志愿者

入选标准

  • excessive daytime sleepiness (Epworth Sleepiness Scale score > 9),
  • sleep complaint such as sleep apnea or insomnia (Basic Nordic Sleep Questionnaire, items score < 4 except questions 3, 4 and 15a for aged volunteers),
  • not intermediate in terms of morningness and eveningness according to the Horne-Ostberg questionnaire for young volunteers
  • absence of psychopathology evidenced during psychologist interview or on the Symptom Check List (SCL-90R score>59)
  • sleep efficiency evidenced by actimetry (>85%) during 7 days
  • absence of apnea/hypopnea syndrome (RDI<15)
  • absence of periodic movement disorder (MPS<15)
  • regular sleep schedule during 3 days before study participation
  • affiliated to the french health care system

排除标准

  • volunteers with sleep disorders or organic disorders affecting sleep,
  • poor sleep hygiene or abnormal usual sleep patterns,
  • night workers or shift-workers,
  • substance abusers (caffeine, drug, or alcohol).

研究组 & 干预措施

Y1

Experimental

young volunteers (20-30 years), morningness chronotype

干预措施: Sleep deprivation and multiple rest (Other)

Y2

Experimental

young volunteers (20-30 years), eveningness chronotype

干预措施: Sleep deprivation and multiple rest (Other)

O1

Experimental

Aged volunteers (65-75 years), morningness chronotype

干预措施: Sleep deprivation and multiple rest (Other)

O 2

Experimental

aged volunteers (65-75 years), eveningness chronotype

干预措施: Sleep deprivation and multiple rest (Other)

结局指标

主要结局

Executive functions will be evaluated by a Go/NoGo task and a Stop Signal. Performances will be measured with a visual simple reaction time task

时间窗: every 3h45

次要结局

  • Nocturnal sleep quality before and after 2 constant conditions measured by PSG Sleep pressure quantified by Karolinska test and EEG delta band Subjective sleepiness and fatigue evaluated by Karolinska sleepiness scale and visual analogue scale(every 3h45)

研究者

发起方
University Hospital, Bordeaux
申办方类型
Other
责任方
Sponsor

研究点 (6)

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