Influence of Light on Sleep, Awakening, Electroencephalogram (EEG) and Cognitive Performances (CHRONOSOMNO)

Influence of Light on Sleep, Awakening, Electroencephalogram (EEG) and Cognitive Performances, and Medical Technology Assessment for Registration and Long-term EEG Analysis

The purpose of this project is to study the influence of light on sleep, wakefulness, EEG activity and cognitive performances. The study aim also to evaluate techniques for registration and analysis of the EEG over periods of time.

Study Overview

• Status: Completed
• Conditions: Human Sleep and Chronobiology
• Intervention / Treatment: Other: Application of white polychromatic light for 2h30 at different times of day

• Study Type: Interventional
• Enrollment (Actual): 92
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Strasbourg, France, 67091
    • Hôpitaux Universitaires de Strasbourg

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 and an ophthalmologic examination
• Topic 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
• Subject affiliated 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
• Allergy to neoprene or lycra
• Dysfunction of the temporomandibular joint (TMJD)
• Blood donation in the previous 3 months before the inclusion
• Participation in other clinical trials in the previous 3 months before the inclusion
• Work by shifts in the year preceding the inclusion
• Trans-meridian travel (> 2 time zones) in the month previous the inclusion
• Contraindications to the use of the medical device
• 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

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

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: white polychromatic light A	Other: Application of white polychromatic light for 2h30 at different times of day
Experimental: white polychromatic light B	Other: Application of white polychromatic light for 2h30 at different times of day
Experimental: white polychromatic light C	Other: Application of white polychromatic light for 2h30 at different times of day
Experimental: white polychromatic light D	Other: Application of white polychromatic light for 2h30 at different times of day

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cognitive performances assessed using Paced Visual Serial Addition Task (PVSAT)	Paced Visual Serial Addition Task (PVSAT)	up to 56 hours
Analysis of EEG activity	sleep fragmentation	up to 56 hours
Cognitive performances assessed using Psychomotor vigilance task (PVT)	Psychomotor vigilance task (PVT)	up to 56 hours
Cognitive performances assessed using Sustained Attention to Response Task (SART)	Sustained Attention to Response Task (SART)	up to 56 hours
Cognitive performances assessed using Digit Symbol Substitution Test (DSST)	Digit Symbol Substitution Test (DSST)	up to 56 hours
Cognitive performances assessed using N-back tasks	N-back tasks	up to 56 hours
Cognitive performances assessed using Visual analogue scales (VAS) for motivation	Visual analogue scales (VAS) for motivation	up to 56 hours
Cognitive performances assessed using Positive and Negative Affect Scale (PANAS)	Positive and Negative Affect Scale (PANAS)	up to 56 hours
Cognitive performances assessed using Karolinska Sleepiness Scale (KSS)	Karolinska Sleepiness Scale (KSS)	up to 56 hours
Cognitive performances assessed using Visual Comfort Scale (VCS)	Visual Comfort Scale (VCS)	up to 56 hours
Cognitive performances assessed using Racing and Crowded Thoughts Questionnaire (RCTQ)	Racing and Crowded Thoughts Questionnaire (RCTQ)	up to 56 hours
Cognitive performances assessed using Mental Effort Rating Scale (RSME)	Mental Effort Rating Scale (RSME)	up to 56 hours
Cognitive performances assessed using Karolinska Drowsiness Test (KDT)	Karolinska Drowsiness Test (KDT)	up to 56 hours

Collaborators and Investigators

• Sponsor: University Hospital, Strasbourg, France

Publications and helpful links

General Publications

• Glacet R, Reynaud E, Robin-Choteau L, Reix N, Hugueny L, Ruppert E, Geoffroy PA, Kilic-Huck U, Comtet H, Bourgin P. A comparison of four methods to estimate dim light melatonin onset: a repeatability and agreement study. Chronobiol Int. 2023 Feb;40(2):123-131. doi: 10.1080/07420528.2022.2150554. Epub 2022 Dec 15.

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2016
• Primary Completion (Actual): June 1, 2019
• Study Completion (Actual): June 1, 2019

Study Registration Dates

• First Submitted: May 30, 2016
• First Submitted That Met QC Criteria: August 5, 2016
• First Posted (Estimated): August 8, 2016

Study Record Updates

• Last Update Posted (Estimated): December 19, 2025
• Last Update Submitted That Met QC Criteria: December 12, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: 6187

Plan for Individual participant data (IPD)

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