Study of Effects of Light on the Vigilance and Cognitive Performance Following a Night Without Sleep
LUMI
1 other identifier
interventional
18
1 country
1
Brief 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 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable healthy-volunteers
Started May 2015
Shorter than P25 for not_applicable healthy-volunteers
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 26, 2015
CompletedStudy Start
First participant enrolled
May 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2015
CompletedFirst Posted
Study publicly available on registry
June 23, 2015
CompletedDecember 22, 2025
December 1, 2025
1 month
January 26, 2015
December 15, 2025
Conditions
Outcome Measures
Primary Outcomes (2)
Analysis of the perception of fatigue
Karolinska Sleepiness Scale 3 sessions :
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
Compare during the 3 sessions : energy-light lamp, luminettes lamp and control condition
Secondary Outcomes (1)
Cognitive performance
Compare during the 3 sessions : energy-light lamp, luminettes lamp and control condition
Study Arms (1)
Experimental
EXPERIMENTALInterventions
Exposure of the subject, at 5am, to the light source of Energy-Light lamp (Philips)
Exposure of the subject, at 5am, to the light source of Luminettes lamp (Lucimed)
No exposure of the subject to any light sources (control condition)
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
- Subject under guardianship or curatorship
- pregnancy
- breastfeeding
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Unité du Sommeil - Hôpitaux Universitaires de Strasbourg
Strasbourg, 67091, France
Related Publications (1)
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.
PMID: 31792259RESULT
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 26, 2015
First Posted
June 23, 2015
Study Start
May 1, 2015
Primary Completion
June 1, 2015
Study Completion
June 1, 2015
Last Updated
December 22, 2025
Record last verified: 2025-12