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临床试验/NCT03978026
NCT03978026已完成不适用

Evaluation de l'efficacité Sur la Vigilance et Les Performances de Conduite simulée d'Une Sieste effectuée Dans Des Environnements différents, Dont le Module SOMBOX

University Hospital, Caen1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2019年5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
入组人数
40
试验地点
1
主要终点
driving performances

研究概览

简要总结

The objective of this study is to assess the effectiveness of naps under different environmental conditions and a rest without nap, on driving, alertness and psychomotor performance.

This study also aims to record during nap time, sleep, body temperature and heart rate.

详细描述

Nap time is one of the most effective means of combating decreased alertness throughout the day and maintaining cognitive and psychomotor performance.

As such, it is recommended for long-haul drivers driving their vehicle. However, these drivers have no alternative but to sleep in their seats. These conditions are not optimal for producing quality sleep. The motorcyclist, for his part, has no chance of sleeping without finding a place to feel safe to give himself up to sleep. On these bases, SOMBOX has developed a mini-hotel allowing drivers to find an optimized place to take a nap.

Investigators propose an experimental study to evaluate the effectiveness, on simulator driving performance and on the results obtained during cognitive and motor testing, of a nap taken under three different conditions. The effect of the nap will be assessed by comparison to a rest awake.

This study should include healthy volunteer participants.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Sequential
主要目的
Basic Science
盲法
Single (Investigator)

盲法说明

Participants will be recorded by technicians and results stored anonymously for traitement

入排标准

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

入选标准

  • •-Male and female participants, aged 20 to 50 years in good health, good sleepers (>8h on average), not being extreme chronotypes, without sleep disorders, healthy, unmedicated, not working in shift work, having been licensed for at least 2 years and driving a minimum of 5000 km per year
  • •The need for the collection of the signature of informed consent
  • •The need to be affiliated with the social security system
  • •The need to understand French

排除标准

  • •participant with a sleep disorder, even if not medicated
  • •participant with extreme morning or evening chronotype
  • •pregnancy
  • •ill or medicated participant

研究组 & 干预措施

no nap in a bed

Sham Comparator

the participant stay awaked for 30 min in a bed in a bedroom

干预措施: Nap (Behavioral)

nap in a bed

Experimental

the participants take a nap of 30 min in a bed in a bedroom

干预措施: Nap (Behavioral)

nap in an armchair

Experimental

the participants take a nap of 30 min in a car sit in a bedroom

干预措施: Nap (Behavioral)

nap in teh Sombox

Experimental

the participants take a nap of 30 min in the micro-hotel Sombox

干预措施: Nap (Behavioral)

结局指标

主要结局

driving performances

时间窗: baseline

number of lateral deviations of the vehicule

sleepiness (vigilance)

时间窗: baseline

Psychomotor vigilance test (PVT)

fatigue (vigilance)

时间窗: baseline

Karolinska Sleepiness Scale (KSS),

motor coordination (vigilance)

时间窗: baseline

the angle of the steering wheel

次要结局

  • sleep(baseline)
  • temperature(baseline)
  • heart rate(baseline)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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