Chronic Sleep Restriction and Driving in Healthy Subjects or Snorers : Interindividual Vulnerability and Recovery Factors
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 4
- 主要终点
- Standard deviation from the centre of the road on driving simulator
研究概览
简要总结
Young subjects and patients with nocturnal respiratory disorders are frequently involved in sleep-related accidents. This study assess the impact of chronic sleep restriction (4 hr of sleep during 5 days) or total sleep deprivation in young or mature healthy subjects or snorers on simulated driving, objective and subjective sleepiness and objective and subjective cognitive performances. The effects of recovery night on these parameters are also assessed.
详细描述
Principal objective :
To determine whether chronic sleep restriction affects more snorers driving performances than healthy subjects' driving performances.
To determine whether chronic sleep restriction affects more young people driving performances than mature subjects' driving performances.
Secondary objective :
To determine whether chronic sleep restriction affects more snorers reaction time performance and sleepiness than non snorers subjects'.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 55 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Healthy subjects inclusion criteria :
- •Healthy males without snoring nor subjective daytime sleepiness (Epworth <9)
- •Intermediate chronotype
- •Hypopnea/apnea index <5
- •Periodic movement index <5
- •Sleep efficiency > 85 %
- •Not taking medication modifying alertness
- •Mean driving distance per year 15000 km
- •Regular sleep-wake schedule.
- •Snorers inclusion criteria :
- •Snoring males without subjective daytime sleepiness (Epworth <9)
- •Intermediate chronotype
- •Hypopnea/apnea index <5
- •Periodic movement index < 5
- •Sleep efficiency > 85 %
- •Not taking medication modifying alertness
- •Mean driving distance per year 15000 km
- •Regular sleep-wake schedule
排除标准
- •Healthy subjects exclusion criteria :
- •Short or long sleeper
- •Shift- or night-worker
- •Sleep, mood, neurological, cardiovascular, pulmonary, endocrinological,… disorders
- •Consumption of illicit drugs.
- •Snorers exclusion criteria :
- •Short or long sleeper
- •Shift- or night-worker
- •Mood, neurological, cardiovascular, pulmonary, endocrinological,… disorders,
- •Sleep disorder except snoring
- •Consumption of illicit drugs.
研究组 & 干预措施
1
snorers
干预措施: Chronic sleep restriction and driving simulator (Other)
2
healthy volonters (control)
干预措施: Chronic sleep restriction and driving simulator (Other)
3
young subjects
干预措施: Chronic sleep restriction and driving simulator (Other)
4
mature subjects
干预措施: Chronic sleep restriction and driving simulator (Other)
结局指标
主要结局
Standard deviation from the centre of the road on driving simulator
时间窗: 1 week
次要结局
- Number of inappropriate line crossing on driving simulator Number of lapses assessed by SRTT 10 % of slowest reaction time Mean sleep latency at 6*20-minutes multi sleep latency test. Subjective sleepiness (Karolinska and VAS) Nocturnal PSG(1 week)