Study of Effects of Light on the Vigilance and Cognitive Performance Following a Night Without Sleep (LUMI)

University Hospital, Strasbourg, France

Status: Completed

Conditions: Healthy Volunteers

Treatments: Device: Energy-Light lamp; Other: control condition; Device: Luminettes lamp

Study type: Interventional

Funder types: Other

Identifiers

NCT02478528

6191

Details and patient eligibility

About

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.

Enrollment: 18 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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18 participants in 1 patient group

Experimental

Experimental group

Treatment:

Device: Luminettes lamp

Other: control condition

Device: Energy-Light lamp