Influence of Light on Sleep, Awakening, Electroencephalogram (EEG) and Cognitive Performances, and Medical Technology Assessment for Registration and Long-term EEG Analysis
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Human Sleep and Chronobiology
- Sponsor
- University Hospital, Strasbourg, France
- Enrollment
- 92
- Locations
- 1
- Primary Endpoint
- Cognitive performances assessed using Karolinska Sleepiness Scale (KSS)
- Status
- Completed
- Last Updated
- 4 months ago
Overview
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.
Investigators
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
Outcomes
Primary Outcomes
Cognitive performances assessed using Karolinska Sleepiness Scale (KSS)
Time Frame: up to 56 hours
Karolinska Sleepiness Scale (KSS)
Analysis of EEG activity
Time Frame: up to 56 hours
sleep fragmentation
Cognitive performances assessed using Digit Symbol Substitution Test (DSST)
Time Frame: up to 56 hours
Digit Symbol Substitution Test (DSST)
Cognitive performances assessed using Mental Effort Rating Scale (RSME)
Time Frame: up to 56 hours
Mental Effort Rating Scale (RSME)
Cognitive performances assessed using Psychomotor vigilance task (PVT)
Time Frame: up to 56 hours
Psychomotor vigilance task (PVT)
Cognitive performances assessed using Sustained Attention to Response Task (SART)
Time Frame: up to 56 hours
Sustained Attention to Response Task (SART)
Cognitive performances assessed using N-back tasks
Time Frame: up to 56 hours
N-back tasks
Cognitive performances assessed using Paced Visual Serial Addition Task (PVSAT)
Time Frame: up to 56 hours
Paced Visual Serial Addition Task (PVSAT)
Cognitive performances assessed using Visual analogue scales (VAS) for motivation
Time Frame: up to 56 hours
Visual analogue scales (VAS) for motivation
Cognitive performances assessed using Visual Comfort Scale (VCS)
Time Frame: up to 56 hours
Visual Comfort Scale (VCS)
Cognitive performances assessed using Positive and Negative Affect Scale (PANAS)
Time Frame: up to 56 hours
Positive and Negative Affect Scale (PANAS)
Cognitive performances assessed using Karolinska Drowsiness Test (KDT)
Time Frame: up to 56 hours
Karolinska Drowsiness Test (KDT)
Cognitive performances assessed using Racing and Crowded Thoughts Questionnaire (RCTQ)
Time Frame: up to 56 hours
Racing and Crowded Thoughts Questionnaire (RCTQ)