Human Sleep and ChronobiologyCHRONOSOMNONCT02858765
Influence of Light on Sleep, Awakening, Electroencephalogram (EEG) and Cognitive Performances
A study testing Application of white polychromatic light for 2h30 at different times of day in people with Human Sleep and Chronobiology, run by University Hospital, Strasbourg, France at 1 site in France.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Human Sleep and Chronobiology
- What is being tested?
- Application of white polychromatic light for 2h30 at different times of day
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 92 participants
- Where
- 1 siteFrance
- Study dates
- Jun 2016to Jun 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
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- 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
Who cannot join
- somatic diseases: cardiovascular, respiratory, gastrointestinal, hematopoietic, Visual
- immune system diseases
- kidneys and urinary tract diseases
- endocrine and metabolic diseases
- neurological diseases
- infectious diseases
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Human Sleep and Chronobiology
- Being tested
- Application of white polychromatic light for 2h30 at different times of day
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Application of white polychromatic light for 2h30 at different times of dayOther
| Study group | Role | What they receive |
|---|---|---|
| white polychromatic light A | Experimental | Not described Receives: Other: Application of white polychromatic light for 2h30 at different times of day |
| white polychromatic light B | Experimental | Not described Receives: Other: Application of white polychromatic light for 2h30 at different times of day |
| white polychromatic light C | Experimental | Not described Receives: Other: Application of white polychromatic light for 2h30 at different times of day |
| white polychromatic light D | Experimental | Not described Receives: Other: Application of white polychromatic light for 2h30 at different times of day |
What is being measured
The primary outcome is the main question the study is designed to answer.
Analysis of EEG activity
sleep fragmentation
Measured: up to 56 hours
Cognitive performances assessed using Psychomotor vigilance task (PVT)
Psychomotor vigilance task (PVT)
Measured: up to 56 hours
Cognitive performances assessed using Sustained Attention to Response Task (SART)
Sustained Attention to Response Task (SART)
Measured: up to 56 hours
Cognitive performances assessed using Digit Symbol Substitution Test (DSST)
Digit Symbol Substitution Test (DSST)
Measured: up to 56 hours
Cognitive performances assessed using N-back tasks
N-back tasks
Measured: up to 56 hours
Cognitive performances assessed using Paced Visual Serial Addition Task (PVSAT)
Paced Visual Serial Addition Task (PVSAT)
Measured: up to 56 hours
Cognitive performances assessed using Visual analogue scales (VAS) for motivation
Visual analogue scales (VAS) for motivation
Measured: up to 56 hours
Cognitive performances assessed using Positive and Negative Affect Scale (PANAS)
Positive and Negative Affect Scale (PANAS)
Measured: up to 56 hours
Cognitive performances assessed using Karolinska Sleepiness Scale (KSS)
Karolinska Sleepiness Scale (KSS)
Measured: up to 56 hours
Cognitive performances assessed using Visual Comfort Scale (VCS)
Visual Comfort Scale (VCS)
Measured: up to 56 hours
Cognitive performances assessed using Racing and Crowded Thoughts Questionnaire (RCTQ)
Racing and Crowded Thoughts Questionnaire (RCTQ)
Measured: up to 56 hours
Cognitive performances assessed using Mental Effort Rating Scale (RSME)
Mental Effort Rating Scale (RSME)
Measured: up to 56 hours
Cognitive performances assessed using Karolinska Drowsiness Test (KDT)
Karolinska Drowsiness Test (KDT)
Measured: up to 56 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2016 (estimated)
- Study startJun 2016
- Primary completionJun 2019
- Study completionJun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Human Sleep and ChronobiologyStudies of the same condition, open and under way.
- More trials run by University Hospital, Strasbourg, FranceThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 92 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Strasbourg, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02858765
- Sponsor's protocol ID
- 6187
- Acronym
- CHRONOSOMNO
- Status last verified
- Dec 2025
- First submitted
- 30 May 2016
- Last updated
- 19 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
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.
PubMed 36519316Walter A, Martz E, Weiner L, Comtet H, Glacet R, Kilic-Huck U, Bourgin P, Schroder CM, Weibel S. Sleep, rest-activity rhythm, cognitive and emotional symptoms in adult ADHD: unraveling the links with an actimetry-based approach. BMC Psychiatry. 2026 Mar 9;26(1):317. doi: 10.1186/s12888-026-07947-9.
PubMed 41803808
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Light on Sleep, Awakening, Electroencephalogram (EEG) and Cognitive Performances, and Medical Technology Assessment for Registration and Long-term EEG Analysis
- ClinicalTrials.gov ID
- NCT02858765
- Acronym / sponsor ID
- CHRONOSOMNO / 6187
- Conditions
- Human Sleep and Chronobiology
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 92 participants (actual)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Study start
- Jun 2016 (actual)
- Primary completion
- Jun 2019 (actual)
- Study completion
- Jun 2019 (actual)
- First posted
- 8 Aug 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| white polychromatic light A | Experimental | Other: Application of white polychromatic light for 2h30 at different times of day |
| white polychromatic light B | Experimental | Other: Application of white polychromatic light for 2h30 at different times of day |
| white polychromatic light C | Experimental | Other: Application of white polychromatic light for 2h30 at different times of day |
| white polychromatic light D | Experimental | Other: Application of white polychromatic light for 2h30 at different times of day |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- 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")
Key exclusion criteria (22 listed)
- somatic diseases: cardiovascular, respiratory, gastrointestinal, hematopoietic, Visual
- immune system diseases
- kidneys and urinary tract diseases
- endocrine and metabolic diseases
- neurological diseases
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Application of white polychromatic light for 2h30 at different times of day | Other | white polychromatic light A, white polychromatic light B, white polychromatic light C, white polychromatic light D |
Primary outcome
Analysis of EEG activity
Time frame: up to 56 hours
sleep fragmentation
Cognitive performances assessed using Psychomotor vigilance task (PVT)
Time frame: up to 56 hours
Psychomotor vigilance task (PVT)
Cognitive performances assessed using Sustained Attention to Response Task (SART)
Time frame: up to 56 hours
Sustained Attention to Response Task (SART)
Cognitive performances assessed using Digit Symbol Substitution Test (DSST)
Time frame: up to 56 hours
Digit Symbol Substitution Test (DSST)
Cognitive performances assessed using N-back tasks
Time frame: up to 56 hours
N-back tasks
Cognitive performances assessed using Paced Visual Serial Addition Task (PVSAT)
Time frame: up to 56 hours
Paced Visual Serial Addition Task (PVSAT)
Cognitive performances assessed using Visual analogue scales (VAS) for motivation
Time frame: up to 56 hours
Visual analogue scales (VAS) for motivation
Cognitive performances assessed using Positive and Negative Affect Scale (PANAS)
Time frame: up to 56 hours
Positive and Negative Affect Scale (PANAS)
Cognitive performances assessed using Karolinska Sleepiness Scale (KSS)
Time frame: up to 56 hours
Karolinska Sleepiness Scale (KSS)
Cognitive performances assessed using Visual Comfort Scale (VCS)
Time frame: up to 56 hours
Visual Comfort Scale (VCS)
Cognitive performances assessed using Racing and Crowded Thoughts Questionnaire (RCTQ)
Time frame: up to 56 hours
Racing and Crowded Thoughts Questionnaire (RCTQ)
Cognitive performances assessed using Mental Effort Rating Scale (RSME)
Time frame: up to 56 hours
Mental Effort Rating Scale (RSME)
Cognitive performances assessed using Karolinska Drowsiness Test (KDT)
Time frame: up to 56 hours
Karolinska Drowsiness Test (KDT)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2025.
- Results publication: PubMed 36519316Glacet 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.
- Derived from this study: PubMed 41803808Walter A, Martz E, Weiner L, Comtet H, Glacet R, Kilic-Huck U, Bourgin P, Schroder CM, Weibel S. Sleep, rest-activity rhythm, cognitive and emotional symptoms in adult ADHD: unraveling the links with an actimetry-based approach. BMC Psychiatry. 2026 Mar 9;26(1):317. doi: 10.1186/s12888-026-07947-9.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Application of white polychromatic light for 2h30 at different times of day in people with Human Sleep and Chronobiology, run by University Hospital, Strasbourg, France at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Analysis of EEG activity (time frame: up to 56 hours). The study lists 13 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02858765, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Dec 2025.