Recruiting NCT05232383

Benefits and Risks of Artificial Light Exposure: Characterisation of Effects on Alertness, Sleep, Cognitive Performance, Mood and Biological Rhythms

No phase Interventional Human Sleep and Chronobiology

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied: The protocol lists: polychromatic light, polychromatic light, red light, red light.
Who it may be relevant to: Registry conditions: Human Sleep and Chronobiology. Basic parameters: 18 years — 40 years · All.
What needs checking: Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place: France
Next step: Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

The purpose of this project is to study the influence of light on sleep, wakefulness, EEG activity and cognitive performances.

Device polychromatic light
Application of polychromatic light at different times of day
Device polychromatic light
Application of polychromatic light for 2h30 at different times of day with sleep
Device red light
Application of red light at different times of day
Device red light
Application of red light at different times of day with sleep
Device green light
Application of green light at different times of day
Device green light
Application of green light at different times of day with sleep

Cognitive performances assessed using N-back tasks [Time frame: up to 56 hours]
Cognitive performances assessed using Psychomotor Vigilance task (PVT) [Time frame: up to 56 hours]
Cognitive performances assessed using Paced Visual Serial Addition Task (PVSAT) [Time frame: up to 56 hours]

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
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
Subjectaffiliated to a social protection scheme

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
blood donation in the previous 3 months before the inclusion
Participation in other clinical trials
Work by shifts in the year preceding the inclusion
Trans-meridian travel (> 2 time zones) in the month previous the inclusion
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
Diet incompatible with the study's snack choices

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

France · 1 center

NCT: NCT05232383 · 8076