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

NCT05232383 | Recruiting

• 1 other identifier: 8076
• Study Type: interventional
• Target: 96
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Human Sleep and Chronobiology

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (6)

Wp

ACTIVE COMPARATOR

Device: polychromatic light

Wn

ACTIVE COMPARATOR

Device: polychromatic light

Gn

ACTIVE COMPARATOR

Device: green light

Gp

ACTIVE COMPARATOR

Device: green light

Rp

ACTIVE COMPARATOR

Device: red light

Rn

ACTIVE COMPARATOR

Device: red light

Interventions

polychromatic light DEVICE

Application of polychromatic light at different times of day

Wp

red light DEVICE

Application of red light at different times of day

Rp

green light DEVICE

Application of green light at different times of day

Gp

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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
• Participation in other clinical trials
• 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)

Sponsors & Collaborators

• University Hospital, Strasbourg, France: lead

Study Sites (1)

Hôpitaux Universitaires de Strasbourg

Strasbourg, 67091, France

RECRUITING

Study Officials

• Patrice BOURGIN, MD

  Hôpitaux Universitaires de Strasbourg

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Patrice BOURGIN, MD

CONTACT

03 88 11 64 30; pbourgin@unistra.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 18, 2021
• First Posted: February 9, 2022
• Study Start: December 2, 2021
• Primary Completion: April 2, 2026
• Study Completion: May 1, 2026
• Last Updated: August 8, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)