NCT02478528

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
18

participants targeted

Target at below P25 for not_applicable healthy-volunteers

Timeline
Completed

Started May 2015

Shorter than P25 for not_applicable healthy-volunteers

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 26, 2015

Completed
3 months until next milestone

Study Start

First participant enrolled

May 1, 2015

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2015

Completed
22 days until next milestone

First Posted

Study publicly available on registry

June 23, 2015

Completed
Last Updated

December 22, 2025

Status Verified

December 1, 2025

Enrollment Period

1 month

First QC Date

January 26, 2015

Last Update Submit

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

EXPERIMENTAL
Device: Energy-Light lampDevice: Luminettes lampOther: control condition

Interventions

Exposure of the subject, at 5am, to the light source of Energy-Light lamp (Philips)

Experimental

Exposure of the subject, at 5am, to the light source of Luminettes lamp (Lucimed)

Experimental

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

Experimental

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

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

Location

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.

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

Locations