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

University Hospital, Strasbourg, France

Status: Enrolling

Conditions: Human Sleep and Chronobiology

Treatments: Device: green light; Device: polychromatic light; Device: red light

Study type: Interventional

Funder types: Other

Identifiers

NCT05232383

8076

Details and patient eligibility

About

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

Enrollment: 96 estimated patients

Sex: All

Ages: 18 to 40 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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96 participants in 6 patient groups

Wp

Active Comparator group

Treatment:

Device: polychromatic light

Device: polychromatic light

Wn

Active Comparator group

Treatment:

Device: polychromatic light

Device: polychromatic light

Gn

Active Comparator group

Treatment:

Device: green light

Device: green light

Gp

Active Comparator group

Treatment:

Device: green light

Device: green light

Rp

Active Comparator group

Treatment:

Device: red light

Device: red light

Rn

Active Comparator group

Treatment:

Device: red light

Device: red light