- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02478528
Study of Effects of Light on the Vigilance and Cognitive Performance Following a Night Without Sleep (LUMI)
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 Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Strasbourg, France, 67091
- Unité du Sommeil - Hôpitaux Universitaires de Strasbourg
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
- Subject under guardianship or curatorship
- pregnancy
- breastfeeding
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Experimental
|
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)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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 :
|
Compare during the 3 sessions : energy-light lamp, luminettes lamp and control condition
|
|
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
|
Compare during the 3 sessions : energy-light lamp, luminettes lamp and control condition
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Cognitive performance
Time Frame: Compare during the 3 sessions : energy-light lamp, luminettes lamp and control condition
|
neurobehavioral tests
|
Compare during the 3 sessions : energy-light lamp, luminettes lamp and control condition
|
Collaborators and Investigators
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 6191
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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