Healthy VolunteersLUMINCT02478528
Study of Effects of Light on the Vigilance and Cognitive Performance Following a Night Without Sleep
A study testing Energy-Light lamp and Luminettes lamp in people with Healthy Volunteers, run by University Hospital, Strasbourg, France at 1 site in France.
Trial summary
Sleep disorders are a major public health issue, affecting 1 in 6 French. The medical impact at the individual level but also social and economic level (loss of productivity, morbidity, mortality) emphasize the need for one hand, to improve the investigators' understanding of these disorders in order to develop… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- Energy-Light lamp and Luminettes lamp
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteFrance
- Study dates
- May 2015to Jun 2015
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Man or woman
- Age from 18 to 40 years
- With a Body Mass Index (BMI) between 17 and 30 kg m-2
- Healthy volunteer determined by clinical examination and psychological interview
- Agreeing to abstain from caffeine, nicotine, alcohol, psychotropic drugs, cannabis or other drugs, the week before the start of Stage 2 of the study until the end of the study
- Dated and signed informed consent
- Subjet affiliated to a social security scheme
- Subject has been informed about the results of the medical examination
Who cannot join
- Participation in other clinical trials in the month preceding the inclusion
- Shift work in the year before inclusion
- Cons-indications to the use of the medical device
- Ocular disease
- Unable to give informations to the subject (subject in an emergency situation, difficulties in understanding, ...)
- Subjet under judicial protection
Show all 9Show fewer
- Subject under guardianship or curatorship
- pregnancy
- breastfeeding
Trial locations and contacts
1 site in 1 country.
France1 site
Unité du Sommeil - Hôpitaux Universitaires de Strasbourg
Strasbourg, 67091
About this study
Sleep disorders are a major public health issue, affecting 1 in 6 French. The medical impact at the individual level but also social and economic level (loss of productivity, morbidity, mortality) emphasize the need for one hand, to improve the investigators' understanding of these disorders in order to develop appropriate therapeutic tools and on the other hand, to increase the investigators' support abilities of patients with these disorders.
The investigators' team of unity sleep from Strasbourg University Hospitals, in collaboration with the UPR 3212 CNRS team, is working on the development and adjustment of new concepts and tools to compensate the investigators' sleep debt in order to apply them to patients with sleep disorders and persons who face with sleep restriction.
- Conditions
- Healthy Volunteers
- Being tested
- Energy-Light lamp, Luminettes lamp, control condition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Energy-Light lampDevice
Exposure of the subject, at 5am, to the light source of Energy-Light lamp (Philips)
Luminettes lampDevice
Exposure of the subject, at 5am, to the light source of Luminettes lamp (Lucimed)
control conditionOther
No exposure of the subject to any light sources (control condition)
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Experimental | Not described Receives: Device: Energy-Light lamp; Device: Luminettes lamp; Other: control condition |
What is being measured
The primary outcome is the main question the study is designed to answer.
Analysis of the perception of fatigue
Karolinska Sleepiness Scale 3 sessions :
Measured: Compare during the 3 sessions : energy-light lamp, luminettes lamp and control condition
Analysis of the circadian variation of melatonin and cortisol secretion
cortisol and melatonin dosage
Measured: Compare during the 3 sessions : energy-light lamp, luminettes lamp and control condition
Secondary outcomes (1)
Cognitive performance
neurobehavioral tests
Measured: Compare during the 3 sessions : energy-light lamp, luminettes lamp and control condition
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2015 (estimated)
- Study startMay 2015
- Primary completionJun 2015
- Study completionJun 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Healthy VolunteersStudies 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
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 18 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
- NCT02478528
- Sponsor's protocol ID
- 6191
- Acronym
- LUMI
- Status last verified
- Dec 2025
- First submitted
- 26 Jan 2015
- Last updated
- 22 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
Publications
Comtet H, Geoffroy PA, Kobayashi Frisk M, Hubbard J, Robin-Choteau L, Calvel L, Hugueny L, Viola AU, Bourgin P. Light therapy with boxes or glasses to counteract effects of acute sleep deprivation. Sci Rep. 2019 Dec 2;9(1):18073. doi: 10.1038/s41598-019-54311-x.
PubMed 31792259
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Effects of Light on the Vigilance and Cognitive Performance Following a Night Without Sleep
- ClinicalTrials.gov ID
- NCT02478528
- Acronym / sponsor ID
- LUMI / 6191
- Conditions
- Healthy Volunteers
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Study start
- May 2015
- Primary completion
- Jun 2015 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 23 Jun 2015 (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.
Sleep disorders are a major public health issue, affecting 1 in 6 French. The medical impact at the individual level but also social and economic level (loss of productivity, morbidity, mortality) emphasize the need for one hand, to improve the investigators' understanding of these disorders in order to develop appropriate therapeutic tools and on the other hand, to increase the investigators' support abilities of patients with these disorders.
The investigators' team of unity sleep from Strasbourg University Hospitals, in collaboration with the UPR 3212 CNRS team, is working on the development and adjustment of new concepts and tools to compensate the investigators' sleep debt in order to apply them to patients with sleep disorders and persons who face with sleep restriction.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Device: Energy-Light lamp, Device: Luminettes lamp, Other: control condition |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Man or woman
- Age from 18 to 40 years
- With a Body Mass Index (BMI) between 17 and 30 kg m-2
- Healthy volunteer determined by clinical examination and psychological interview
- Agreeing to abstain from caffeine, nicotine, alcohol, psychotropic drugs, cannabis or other drugs, the week before the start of Stage 2 of the study until the end of the study
Key exclusion criteria (9 listed)
- Participation in other clinical trials in the month preceding the inclusion
- Shift work in the year before inclusion
- Cons-indications to the use of the medical device
- Ocular disease
- Unable to give informations to the subject (subject in an emergency situation, difficulties in understanding, ...)
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 |
|---|---|---|
| Energy-Light lampExposure of the subject, at 5am, to the light source of Energy-Light lamp (Philips) | Device | Experimental |
| Luminettes lampExposure of the subject, at 5am, to the light source of Luminettes lamp (Lucimed) | Device | Experimental |
| control conditionNo exposure of the subject to any light sources (control condition) | Other | Experimental |
Primary outcome
Analysis of the perception of fatigue
Time frame: Compare during the 3 sessions : energy-light lamp, luminettes lamp and control condition
Karolinska Sleepiness Scale 3 sessions :
Analysis of the circadian variation of melatonin and cortisol secretion
Time frame: Compare during the 3 sessions : energy-light lamp, luminettes lamp and control condition
cortisol and melatonin dosage
1 secondary outcome
Cognitive performance
Time frame: Compare during the 3 sessions : energy-light lamp, luminettes lamp and control condition
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 22 Dec 2025.
- Results publication: PubMed 31792259Comtet H, Geoffroy PA, Kobayashi Frisk M, Hubbard J, Robin-Choteau L, Calvel L, Hugueny L, Viola AU, Bourgin P. Light therapy with boxes or glasses to counteract effects of acute sleep deprivation. Sci Rep. 2019 Dec 2;9(1):18073. doi: 10.1038/s41598-019-54311-x.
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Screening Protocol
Pain
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 Energy-Light lamp and Luminettes lamp in people with Healthy Volunteers, 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 8 inclusion and 9 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 22 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 the perception of fatigue (time frame: Compare during the 3 sessions : energy-light lamp, luminettes lamp and control condition). The study lists 2 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 NCT02478528, which also lists 1 linked publication.
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 22 Dec 2025.