Study of Effects of Light on the Vigilance and Cognitive Performance Following a Night Without Sleep

Study Overview
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Brief Summary
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Sleep disorders are a major public health issue, affecting 1 in 6 French. The medical impact at the individual level but also social and economic level (loss of productivity, morbidity, mortality) emphasize the need for one hand, to improve the investigators' understanding of these disorders in order to develop appropriate therapeutic tools and on the other hand, to increase the investigators' support abilities of patients with these disorders. The investigators' team of unity sleep from Strasbourg University Hospitals, in collaboration with the UPR 3212 CNRS team, is working on the development and adjustment of new concepts and tools to compensate the investigators' sleep debt in order to apply them to patients with sleep disorders and persons who face with sleep restriction.

Official Title
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Study of Effects of Light on the Vigilance and Cognitive Performance Following a Night Without Sleep

Conditions
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Healthy Volunteers

Intervention / Treatment
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* Device: Energy-Light lamp
* Device: Luminettes lamp
* Other: control condition


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Man or woman Age from 18 to 40 years With a Body Mass Index (BMI) between 17 and 30 kg m-2 Healthy volunteer determined by clinical examination and psychological interview Agreeing to abstain from caffeine, nicotine, alcohol, psychotropic drugs, cannabis or other drugs, the week before the start of Stage 2 of the study until the end of the study Dated and signed informed consent Subjet affiliated to a social security scheme Subject has been informed about the results of the medical examination Exclusion Criteria: Participation in other clinical trials in the month preceding the inclusion Shift work in the year before inclusion Cons-indications to the use of the medical device Ocular disease Unable to give informations to the subject (subject in an emergency situation, difficulties in understanding, ...) Subjet under judicial protection Subject under guardianship or curatorship pregnancy breastfeeding

Ages Eligible for Study
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Minimum Age: 18 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: Prevention
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental<br> | Device: Energy-Light lamp<br>* Exposure of the subject, at 5am, to the light source of Energy-Light lamp (Philips)<br>Device: Luminettes lamp<br>* Exposure of the subject, at 5am, to the light source of Luminettes lamp (Lucimed)<br>Other: control condition<br>* No exposure of the subject to any light sources (control condition)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Analysis of the perception of fatigue | Karolinska Sleepiness Scale 3 sessions : | Compare during the 3 sessions : energy-light lamp, luminettes lamp and control condition | 
| Analysis of the circadian variation of melatonin and cortisol secretion | cortisol and melatonin dosage | Compare during the 3 sessions : energy-light lamp, luminettes lamp and control condition | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cognitive performance | neurobehavioral tests | Compare during the 3 sessions : energy-light lamp, luminettes lamp and control condition |