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

Not Applicable

Completed

• Conditions: Healthy Volunteers
• Interventions: Device: Energy-Light lamp; Device: Luminettes lamp; Other: control condition

• Registration Number: NCT02478528
• Lead Sponsor: University Hospital, Strasbourg, France

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-01-26
• Study Start: 2015-05
• Primary Completion: 2015-06
• Study Completion: 2015-06
• Study First Submitted QC: 2015-06-17
• Study First Posted: 2015-06-23
• Status Verified: 2016-06
• Last Update Submitted: 2016-06-02
• Last Update Posted: 2016-06-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 18

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Experimental	control condition	-
Experimental	Energy-Light lamp	-
Experimental	Luminettes lamp	-

Primary Outcome Measures

Name	Time	Method
Analysis of the circadian variation of melatonin and cortisol secretion	Compare during the 3 sessions : energy-light lamp, luminettes lamp and control condition	cortisol and melatonin dosage
Analysis of the perception of fatigue	Compare during the 3 sessions : energy-light lamp, luminettes lamp and control condition	Karolinska Sleepiness Scale 3 sessions :

Secondary Outcome Measures

Name	Time	Method
Cognitive performance	Compare during the 3 sessions : energy-light lamp, luminettes lamp and control condition	neurobehavioral tests

Trial Locations

Locations (1)

Unité du Sommeil - Hôpitaux Universitaires de Strasbourg; 🇫🇷 Strasbourg, France