Influence of Light on Sleep, Awakening, Electroencephalogram (EEG) and Cognitive Performances
Not Applicable
Completed
- Conditions
- Human Sleep and Chronobiology
- Interventions
- Other: Application of white polychromatic light for 2h30 at different times of day
- Registration Number
- NCT02858765
- Lead Sponsor
- University Hospital, Strasbourg, France
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 92
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description white polychromatic light C Application of white polychromatic light for 2h30 at different times of day - white polychromatic light D Application of white polychromatic light for 2h30 at different times of day - white polychromatic light A Application of white polychromatic light for 2h30 at different times of day - white polychromatic light B Application of white polychromatic light for 2h30 at different times of day -
- Primary Outcome Measures
Name Time Method Cognitive performances assessed using Visual Comfort Scale (VCS) up to 56 hours Visual Comfort Scale (VCS)
Cognitive performances assessed using N-back tasks up to 56 hours N-back tasks
Analysis of EEG activity up to 56 hours sleep fragmentation
Cognitive performances assessed using Digit Symbol Substitution Test (DSST) up to 56 hours Digit Symbol Substitution Test (DSST)
Cognitive performances assessed using Mental Effort Rating Scale (RSME) up to 56 hours Mental Effort Rating Scale (RSME)
Cognitive performances assessed using Paced Visual Serial Addition Task (PVSAT) up to 56 hours Paced Visual Serial Addition Task (PVSAT)
Cognitive performances assessed using Visual analogue scales (VAS) for motivation up to 56 hours Visual analogue scales (VAS) for motivation
Cognitive performances assessed using Psychomotor vigilance task (PVT) up to 56 hours Psychomotor vigilance task (PVT)
Cognitive performances assessed using Sustained Attention to Response Task (SART) up to 56 hours Sustained Attention to Response Task (SART)
Cognitive performances assessed using Positive and Negative Affect Scale (PANAS) up to 56 hours Positive and Negative Affect Scale (PANAS)
Cognitive performances assessed using Karolinska Drowsiness Test (KDT) up to 56 hours Karolinska Drowsiness Test (KDT)
Cognitive performances assessed using Karolinska Sleepiness Scale (KSS) up to 56 hours Karolinska Sleepiness Scale (KSS)
Cognitive performances assessed using Racing and Crowded Thoughts Questionnaire (RCTQ) up to 56 hours Racing and Crowded Thoughts Questionnaire (RCTQ)
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Hôpitaux Universitaires de Strasbourg
🇫🇷STRASBOURG Cedex, France