Influence of Light on Sleep, Awakening, Electroencephalogram (EEG) and Cognitive Performances, and Medical Technology Assessment for Registration and Long-term EEG Analysis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 92
- 试验地点
- 2
- 主要终点
- Cognitive performances assessed using Karolinska Sleepiness Scale (KSS)
研究概览
简要总结
The purpose of this project is to study the influence of light on sleep, wakefulness, EEG activity and cognitive performances. The study aim also to evaluate techniques for registration and analysis of the EEG over periods of time.
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
- 18 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male or female
- •Aged 18 to 40 years
- •With a hint of Bodymass index (BMI) between 17 and 30 kg.m - 2
- •Healthy subject determined by a clinical examination, a psychological interview, a blood test, a urine analysis and an ophthalmologic examination
- •Topic Subject with a score <6 questionnaire PSQI ("Sleep Questionnaire Pittsburgh")
- •Subject agreeing to maintain a regular sleep/wake rhythm during the study
- •Subject agreeing to refrain from caffeine, nicotine, alcohol, psychotropic drugs, cannabis or other drugs during the study
- •Signed informed consent
- •Subject affiliated to a social protection scheme
排除标准
- •somatic diseases: cardiovascular, respiratory, gastrointestinal, hematopoietic, Visual
- •immune system diseases
- •kidneys and urinary tract diseases
- •endocrine and metabolic diseases
- •neurological diseases
- •infectious diseases
- •thrombocytopenia or other malfunction of blood platelets
- •Subject with risk of thrombosis, including subject with a history of phlebitis, smoker under oral contraceptive...
- •Subject with an addiction to caffeine, nicotine, alcohol, psychotropic drugs, cannabis, or any other drug
- •Subject treatment contraindicated or inadvisable in combination with heparin
- •Allergy to neoprene or lycra
- •Dysfunction of the temporomandibular joint (TMJD)
- •Blood donation in the previous 3 months before the inclusion
- •Participation in other clinical trials in the previous 3 months before the inclusion
- •Work by shifts in the year preceding the inclusion
- •Trans-meridian travel (> 2 time zones) in the month previous the inclusion
- •Contraindications to the use of the medical device
- •Impossibility to give enlightened information (subject in an emergency situation, understanding difficulties,...)
- •Subject under safeguard of justice
- •Subject under tutorship or curatorship
- •Pregnancy (women of childbearing age)
- •Breastfeeding
研究组 & 干预措施
white polychromatic light D
干预措施: Application of white polychromatic light for 2h30 at different times of day (Other)
white polychromatic light A
干预措施: Application of white polychromatic light for 2h30 at different times of day (Other)
white polychromatic light B
干预措施: Application of white polychromatic light for 2h30 at different times of day (Other)
white polychromatic light C
干预措施: Application of white polychromatic light for 2h30 at different times of day (Other)
结局指标
主要结局
Cognitive performances assessed using Karolinska Sleepiness Scale (KSS)
时间窗: up to 56 hours
Karolinska Sleepiness Scale (KSS)
Analysis of EEG activity
时间窗: up to 56 hours
sleep fragmentation
Cognitive performances assessed using Digit Symbol Substitution Test (DSST)
时间窗: up to 56 hours
Digit Symbol Substitution Test (DSST)
Cognitive performances assessed using Mental Effort Rating Scale (RSME)
时间窗: up to 56 hours
Mental Effort Rating Scale (RSME)
Cognitive performances assessed using Psychomotor vigilance task (PVT)
时间窗: up to 56 hours
Psychomotor vigilance task (PVT)
Cognitive performances assessed using Sustained Attention to Response Task (SART)
时间窗: up to 56 hours
Sustained Attention to Response Task (SART)
Cognitive performances assessed using N-back tasks
时间窗: up to 56 hours
N-back tasks
Cognitive performances assessed using Paced Visual Serial Addition Task (PVSAT)
时间窗: up to 56 hours
Paced Visual Serial Addition Task (PVSAT)
Cognitive performances assessed using Visual analogue scales (VAS) for motivation
时间窗: up to 56 hours
Visual analogue scales (VAS) for motivation
Cognitive performances assessed using Visual Comfort Scale (VCS)
时间窗: up to 56 hours
Visual Comfort Scale (VCS)
Cognitive performances assessed using Positive and Negative Affect Scale (PANAS)
时间窗: up to 56 hours
Positive and Negative Affect Scale (PANAS)
Cognitive performances assessed using Karolinska Drowsiness Test (KDT)
时间窗: up to 56 hours
Karolinska Drowsiness Test (KDT)
Cognitive performances assessed using Racing and Crowded Thoughts Questionnaire (RCTQ)
时间窗: up to 56 hours
Racing and Crowded Thoughts Questionnaire (RCTQ)
次要结局
未报告次要终点