Clinical trial NCT02858765: Influence of Light on Sleep, Awakening, Electroencephalogram (EEG) and Cognitive Performances
Official title: Influence of Light on Sleep, Awakening, Electroencephalogram (EEG) and Cognitive Performances, and Medical Technology Assessment for Registration and Long-term EEG Analysis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Human Sleep and Chronobiology
Lead sponsor: University Hospital, Strasbourg, France
Sponsor class: OTHER
First posted: 2016-08-08
Enrollment: 92
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.


Eligibility criteria: 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

Primary outcomes:
measure: Analysis of EEG activity
timeFrame: up to 56 hours
measure: Cognitive performances assessed using Psychomotor vigilance task (PVT)
timeFrame: up to 56 hours
measure: Cognitive performances assessed using Sustained Attention to Response Task (SART)
timeFrame: up to 56 hours
measure: Cognitive performances assessed using Digit Symbol Substitution Test (DSST)
timeFrame: up to 56 hours
measure: Cognitive performances assessed using N-back tasks
timeFrame: up to 56 hours
measure: Cognitive performances assessed using Paced Visual Serial Addition Task (PVSAT)
timeFrame: up to 56 hours
measure: Cognitive performances assessed using Visual analogue scales (VAS) for motivation
timeFrame: up to 56 hours
measure: Cognitive performances assessed using Positive and Negative Affect Scale (PANAS)
timeFrame: up to 56 hours
measure: Cognitive performances assessed using Karolinska Sleepiness Scale (KSS)
timeFrame: up to 56 hours
measure: Cognitive performances assessed using Visual Comfort Scale (VCS)
timeFrame: up to 56 hours
measure: Cognitive performances assessed using Racing and Crowded Thoughts Questionnaire (RCTQ)
timeFrame: up to 56 hours
measure: Cognitive performances assessed using Mental Effort Rating Scale (RSME)
timeFrame: up to 56 hours
measure: Cognitive performances assessed using Karolinska Drowsiness Test (KDT)
timeFrame: up to 56 hours
Secondary outcomes:
Other outcomes:
Locations:
city: STRASBOURG Cedex
country: France
facility: Hôpitaux Universitaires de Strasbourg
Study officials:
References: