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

NCT05232383 — Not applicable, Completed, 96 participants, University Hospital, Strasbourg, France

ClinicalTrials Daily  ·  Areas  ·  Conditions  ·  Drugs  ·  Sponsors  ·  
RegistryNCT05232383, acronym LumEnColor
StatusCompleted
PhaseNot applicable
Study typeInterventional; randomized, parallel, masking: none, basic science
Enrollment96 (Actual)
SponsorUniversity Hospital, Strasbourg, France (Other)
ConditionsHuman Sleep and Chronobiology
Interventionspolychromatic light, red light, green light (Device)
Datesstart 2021-12-02, primary completion 2026-07-31, completion 2026-07-31, first posted 2022-02-09, last updated 2026-08-20
Locations1 site in France

Related Papers Related Patents Related Grants Related Experts
All trials for Human Sleep and Chronobiology All trials of polychromatic light All trials of red light

-Summary

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

Expand all sections  ·  Collapse all

+Arms and interventions

ArmTypeInterventionsDescription
WpActive comparatorDevice: polychromatic light
WnActive comparatorDevice: polychromatic light
GnActive comparatorDevice: green light
GpActive comparatorDevice: green light
RpActive comparatorDevice: red light
RnActive comparatorDevice: red light
  • polychromatic light (Device): Application of polychromatic light at different times of day
  • polychromatic light (Device): Application of polychromatic light for 2h30 at different times of day with sleep
  • red light (Device): Application of red light at different times of day
  • red light (Device): Application of red light at different times of day with sleep
  • green light (Device): Application of green light at different times of day
  • green light (Device): Application of green light at different times of day with sleep

+Outcome measures

Primary outcomes

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

+Eligibility

Sex: All, ages: 18 Years to 40 Years, 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

+Locations (1)

FacilityCityCountryStatus
Hôpitaux Universitaires de StrasbourgStrasbourgFrance

+Investigators

  • Patrice BOURGIN, MD, Principal investigator, Hôpitaux Universitaires de Strasbourg