Clinical trial NCT05232383: Benefits and Risks of Artificial Light Exposure: Characterisation of Effects on Alertness, Sleep, Cognitive Performance, Mood and Biological Rhythms
Official title: Benefits and Risks of Artificial Light Exposure: Characterisation of Effects on Alertness, Sleep, Cognitive Performance, Mood and Biological Rhythms
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Human Sleep and Chronobiology
Lead sponsor: University Hospital, Strasbourg, France
Sponsor class: OTHER
First posted: 2022-02-09
Enrollment: 96
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.


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
* 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

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
* 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

Primary outcomes:
measure: Cognitive performances assessed using N-back tasks
timeFrame: up to 56 hours
measure: Cognitive performances assessed using Psychomotor Vigilance task (PVT)
timeFrame: up to 56 hours
measure: Cognitive performances assessed using Paced Visual Serial Addition Task (PVSAT)
timeFrame: up to 56 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Strasbourg
country: France
facility: Hôpitaux Universitaires de Strasbourg
Study officials:
affiliation: Hôpitaux Universitaires de Strasbourg
name: Patrice BOURGIN, MD
role: PRINCIPAL_INVESTIGATOR
References: