Influence of Light on Sleep, Awakening, Electroencephalogram (EEG) and Cognitive Performances

Study Overview
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Brief Summary
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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.

Official Title
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Influence of Light on Sleep, Awakening, Electroencephalogram (EEG) and Cognitive Performances, and Medical Technology Assessment for Registration and Long-term EEG Analysis

Conditions
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Human Sleep and Chronobiology

Intervention / Treatment
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* Other: Application of white polychromatic light for 2h30 at different times of day


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: white polychromatic light A<br> | Other: Application of white polychromatic light for 2h30 at different times of day<br> <br> |
| Experimental: white polychromatic light B<br> | Other: Application of white polychromatic light for 2h30 at different times of day<br> <br> |
| Experimental: white polychromatic light C<br> | Other: Application of white polychromatic light for 2h30 at different times of day<br> <br> |
| Experimental: white polychromatic light D<br> | Other: Application of white polychromatic light for 2h30 at different times of day<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Analysis of EEG activity | sleep fragmentation | up to 56 hours | 
| Cognitive performances assessed using Psychomotor vigilance task (PVT) | Psychomotor vigilance task (PVT) | up to 56 hours | 
| Cognitive performances assessed using Sustained Attention to Response Task (SART) | Sustained Attention to Response Task (SART) | up to 56 hours | 
| Cognitive performances assessed using Digit Symbol Substitution Test (DSST) | Digit Symbol Substitution Test (DSST) | up to 56 hours | 
| Cognitive performances assessed using N-back tasks | N-back tasks | up to 56 hours | 
| Cognitive performances assessed using Paced Visual Serial Addition Task (PVSAT) | Paced Visual Serial Addition Task (PVSAT) | up to 56 hours | 
| Cognitive performances assessed using Visual analogue scales (VAS) for motivation | Visual analogue scales (VAS) for motivation | up to 56 hours | 
| Cognitive performances assessed using Positive and Negative Affect Scale (PANAS) | Positive and Negative Affect Scale (PANAS) | up to 56 hours | 
| Cognitive performances assessed using Karolinska Sleepiness Scale (KSS) | Karolinska Sleepiness Scale (KSS) | up to 56 hours | 
| Cognitive performances assessed using Visual Comfort Scale (VCS) | Visual Comfort Scale (VCS) | up to 56 hours | 
| Cognitive performances assessed using Racing and Crowded Thoughts Questionnaire (RCTQ) | Racing and Crowded Thoughts Questionnaire (RCTQ) | up to 56 hours | 
| Cognitive performances assessed using Mental Effort Rating Scale (RSME) | Mental Effort Rating Scale (RSME) | up to 56 hours | 
| Cognitive performances assessed using Karolinska Drowsiness Test (KDT) | Karolinska Drowsiness Test (KDT) | up to 56 hours |