Human Sleep and ChronobiologyLumEnColorNCT05232383
Benefits and Risks of Artificial Light Exposure: Characterisation of Effects on Alertness, Sleep, Cognitive Performance, Mood and Biological Rhythms
A study testing polychromatic light, red light and green light 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. 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?
- polychromatic light, red light and green light
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 96 participants
- Where
- 1 siteFrance
- Study dates
- 2 Dec 2021to 31 Jul 2026
- 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
- 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
- Subjectaffiliated 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
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
- Being tested
- polychromatic light, red light, green light
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
polychromatic lightDevice
Application of polychromatic light at different times of day
polychromatic lightDevice
Application of polychromatic light for 2h30 at different times of day with sleep
red lightDevice
Application of red light at different times of day
red lightDevice
Application of red light at different times of day with sleep
green lightDevice
Application of green light at different times of day
green lightDevice
Application of green light at different times of day with sleep
| Study group | Role | What they receive |
|---|---|---|
| Wp | Active comparator | Not described Receives: Device: polychromatic light |
| Wn | Active comparator | Not described Receives: Device: polychromatic light |
| Gn | Active comparator | Not described Receives: Device: green light |
| Gp | Active comparator | Not described Receives: Device: green light |
| Rp | Active comparator | Not described Receives: Device: red light |
| Rn | Active comparator | Not described Receives: Device: red light |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cognitive performances assessed using N-back tasks
N-Back-Task 1, 2, 3
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 Paced Visual Serial Addition Task (PVSAT)
Paced Visual Serial Addition Task (PVSAT)
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 posted9 Feb 2022
- Study start2 Dec 2021
- Primary completion31 Jul 2026
- Study completion31 Jul 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 96 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Strasbourg, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Patrice BOURGIN, MD, Principal investigator, Hôpitaux Universitaires de Strasbourg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05232383
- Sponsor's protocol ID
- 8076
- Acronym
- LumEnColor
- Status last verified
- Aug 2026
- First submitted
- 18 Jan 2021
- Last updated
- 20 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Benefits and Risks of Artificial Light Exposure: Characterisation of Effects on Alertness, Sleep, Cognitive Performance, Mood and Biological Rhythms
- ClinicalTrials.gov ID
- NCT05232383
- Acronym / sponsor ID
- LumEnColor / 8076
- Conditions
- Human Sleep and Chronobiology
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 96 participants (actual)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Study start
- 2 Dec 2021 (actual)
- Primary completion
- 31 Jul 2026 (actual)
- Study completion
- 31 Jul 2026 (actual)
- First posted
- 9 Feb 2022 (actual)
- 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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| 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 |
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
- Subject with a score<6 questionnaire PSQI ("Sleep Questionnaire Pittsburgh")
Key exclusion criteria (20 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 |
|---|---|---|
| polychromatic lightApplication of polychromatic light at different times of day | Device | Wp |
| polychromatic lightApplication of polychromatic light for 2h30 at different times of day with sleep | Device | Wn |
| red lightApplication of red light at different times of day | Device | Rp |
| red lightApplication of red light at different times of day with sleep | Device | Rn |
| green lightApplication of green light at different times of day | Device | Gp |
| green lightApplication of green light at different times of day with sleep | Device | Gn |
Primary outcome
Cognitive performances assessed using N-back tasks
Time frame: up to 56 hours
N-Back-Task 1, 2, 3
Cognitive performances assessed using Psychomotor Vigilance task (PVT)
Time frame: up to 56 hours
Psychomotor Vigilance task (PVT)
Cognitive performances assessed using Paced Visual Serial Addition Task (PVSAT)
Time frame: up to 56 hours
Paced Visual Serial Addition Task (PVSAT)
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 20 Aug 2026.
- 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.
Patrice BOURGIN, MD principal investigator
Hôpitaux Universitaires de Strasbourg
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing polychromatic light, red light and green light 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 20 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 20 Aug 2026. 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?
Cognitive performances assessed using N-back tasks (time frame: up to 56 hours). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 20 Aug 2026.