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

Not Applicable

Recruiting

• Conditions: Human Sleep and Chronobiology
• Interventions: Device: polychromatic light; Device: red light; Device: green light

• Registration Number: NCT05232383
• Lead Sponsor: University Hospital, Strasbourg, France

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-01-18
• Study Start: 2021-12-02
• Study First Submitted QC: 2022-02-08
• Study First Posted: 2022-02-09
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-28
• Last Update Posted: 2024-08-29
• Primary Completion: 2026-04-02
• Study Completion: 2026-05-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 96

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Wn	polychromatic light	-
Rp	red light	-
Wp	polychromatic light	-
Gn	green light	-
Gp	green light	-
Rn	red light	-

Primary Outcome Measures

Name	Time	Method
Cognitive performances assessed using Paced Visual Serial Addition Task (PVSAT)	up to 56 hours	Paced Visual Serial Addition Task (PVSAT)
Cognitive performances assessed using Psychomotor Vigilance task (PVT)	up to 56 hours	Psychomotor Vigilance task (PVT)
Cognitive performances assessed using N-back tasks	up to 56 hours	N-Back-Task 1, 2, 3

Trial Locations

Locations (1)

Hôpitaux Universitaires de Strasbourg; 🇫🇷 Strasbourg, France