CompletedNot Applicable

Influence of Light on Sleep, Awakening, Electroencephalogram (EEG) and Cognitive Performances

France92 participantsStarted 2016-06

Plain-language 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.

Who can participate

Age range

18 Years – 40 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 sh…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Analysis of EEG activity

Timeframe: up to 56 hours

Cognitive performances assessed using Psychomotor vigilance task (PVT)

Timeframe: up to 56 hours

Cognitive performances assessed using Sustained Attention to Response Task (SART)

Timeframe: up to 56 hours

Cognitive performances assessed using Digit Symbol Substitution Test (DSST)

Timeframe: up to 56 hours

Cognitive performances assessed using N-back tasks

Timeframe: up to 56 hours

Cognitive performances assessed using Paced Visual Serial Addition Task (PVSAT)

Timeframe: up to 56 hours

Cognitive performances assessed using Visual analogue scales (VAS) for motivation

Timeframe: up to 56 hours

Trial details

NCT IDNCT02858765

SponsorUniversity Hospital, Strasbourg, France

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2019-06

View on ClinicalTrials.gov More Human Sleep and Chronobiology trials

Who can participate

Age range

18 Years – 40 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Analysis of EEG activity

Timeframe: up to 56 hours

Cognitive performances assessed using Psychomotor vigilance task (PVT)

Timeframe: up to 56 hours

Cognitive performances assessed using Sustained Attention to Response Task (SART)

Timeframe: up to 56 hours

Cognitive performances assessed using Digit Symbol Substitution Test (DSST)

Timeframe: up to 56 hours

Cognitive performances assessed using N-back tasks

Timeframe: up to 56 hours

Cognitive performances assessed using Paced Visual Serial Addition Task (PVSAT)

Timeframe: up to 56 hours

Cognitive performances assessed using Visual analogue scales (VAS) for motivation

Timeframe: up to 56 hours