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

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

Study Overview

• Status: Recruiting
• Conditions: Human Sleep and Chronobiology
• Intervention / Treatment: Device: polychromatic light; Device: polychromatic light; Device: green light; Device: green light; Device: red light; Device: red light

• Study Type: Interventional
• Enrollment (Estimated): 96
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Patrice BOURGIN, MD; Phone Number: 0033 03 88 11 64 30; Email: pbourgin@unistra.fr

Study Locations

• France
  • Strasbourg, France, 67091
    • Recruiting
    • Hôpitaux Universitaires de Strasbourg
    • Contact: Patrice BOURGIN, MD; Phone Number: 03 88 11 64 30; Email: pbourgin@unistra.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

6

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Wp	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
Active Comparator: Wn	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
Active Comparator: Gn	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
Active Comparator: Gp	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
Active Comparator: Rp	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
Active Comparator: Rn	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

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: University Hospital, Strasbourg, France
• Investigators: Principal Investigator: Patrice BOURGIN, MD, Hôpitaux Universitaires de Strasbourg

Study record dates

Study Major Dates

• Study Start (Actual): December 2, 2021
• Primary Completion (Estimated): April 2, 2026
• Study Completion (Estimated): May 1, 2026

Study Registration Dates

• First Submitted: January 18, 2021
• First Submitted That Met QC Criteria: February 8, 2022
• First Posted (Actual): February 9, 2022

Study Record Updates

• Last Update Posted (Actual): August 8, 2025
• Last Update Submitted That Met QC Criteria: August 4, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: 8076

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No