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

December 12, 2025 updated by: University Hospital, Strasbourg, France

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
92

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Strasbourg, France, 67091
        • Hopitaux Universitaires de Strasbourg

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Cognitive performances assessed using Paced Visual Serial Addition Task (PVSAT)
Time Frame: up to 56 hours
Paced Visual Serial Addition Task (PVSAT)
up to 56 hours
Analysis of EEG activity
Time Frame: up to 56 hours
sleep fragmentation
up to 56 hours
Cognitive performances assessed using Psychomotor vigilance task (PVT)
Time Frame: up to 56 hours
Psychomotor vigilance task (PVT)
up to 56 hours
Cognitive performances assessed using Sustained Attention to Response Task (SART)
Time Frame: up to 56 hours
Sustained Attention to Response Task (SART)
up to 56 hours
Cognitive performances assessed using Digit Symbol Substitution Test (DSST)
Time Frame: up to 56 hours
Digit Symbol Substitution Test (DSST)
up to 56 hours
Cognitive performances assessed using N-back tasks
Time Frame: up to 56 hours
N-back tasks
up to 56 hours
Cognitive performances assessed using Visual analogue scales (VAS) for motivation
Time Frame: up to 56 hours
Visual analogue scales (VAS) for motivation
up to 56 hours
Cognitive performances assessed using Positive and Negative Affect Scale (PANAS)
Time Frame: up to 56 hours
Positive and Negative Affect Scale (PANAS)
up to 56 hours
Cognitive performances assessed using Karolinska Sleepiness Scale (KSS)
Time Frame: up to 56 hours
Karolinska Sleepiness Scale (KSS)
up to 56 hours
Cognitive performances assessed using Visual Comfort Scale (VCS)
Time Frame: up to 56 hours
Visual Comfort Scale (VCS)
up to 56 hours
Cognitive performances assessed using Racing and Crowded Thoughts Questionnaire (RCTQ)
Time Frame: up to 56 hours
Racing and Crowded Thoughts Questionnaire (RCTQ)
up to 56 hours
Cognitive performances assessed using Mental Effort Rating Scale (RSME)
Time Frame: up to 56 hours
Mental Effort Rating Scale (RSME)
up to 56 hours
Cognitive performances assessed using Karolinska Drowsiness Test (KDT)
Time Frame: up to 56 hours
Karolinska Drowsiness Test (KDT)
up to 56 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University Hospital, Strasbourg, France

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2016

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2019

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 30, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 5, 2016

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 8, 2016

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 19, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 12, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2025

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 6187

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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