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

Healthy Volunteers Clinical Trial

— LUMI  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02478528
• Other study ID #: 6191
• Status: Completed
• Phase: N/A
• First received: January 26, 2015
• Last updated: June 2, 2016
• Start date: May 2015
• Est. completion date: June 2015

Study information

• Verified date: June 2016
• Source: University Hospital, Strasbourg, France
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé
• Study type: Interventional

Clinical 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 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: June 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

Device:
• Energy-Light lamp
Exposure of the subject, at 5am, to the light source of Energy-Light lamp (Philips)
• Luminettes lamp
Exposure of the subject, at 5am, to the light source of Luminettes lamp (Lucimed)

Other:
• control condition
No exposure of the subject to any light sources (control condition)

Locations

Country	Name	City	State
France	Unité du Sommeil - Hôpitaux Universitaires de Strasbourg	Strasbourg

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Strasbourg, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Analysis of the perception of fatigue	Karolinska Sleepiness Scale 3 sessions :	Compare during the 3 sessions : energy-light lamp, luminettes lamp and control condition	No
Primary	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	No
Secondary	Cognitive performance	neurobehavioral tests	Compare during the 3 sessions : energy-light lamp, luminettes lamp and control condition	No