NCT02858765

Brief Summary

The purpose of this project is to study the influence of light on sleep, wakefulness, EEG activity and cognitive performances. The study aim also to evaluate techniques for registration and analysis of the EEG over periods of time.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
92

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2016

Typical duration for not_applicable

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

May 30, 2016

Completed
2 days until next milestone

Study Start

First participant enrolled

June 1, 2016

Completed
2 months until next milestone

First Posted

Study publicly available on registry

August 8, 2016

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2019

Completed
Last Updated

December 19, 2025

Status Verified

December 1, 2025

Enrollment Period

3 years

First QC Date

May 30, 2016

Last Update Submit

December 12, 2025

Conditions

Outcome Measures

Primary Outcomes (13)

  • Analysis of EEG activity

    sleep fragmentation

    up to 56 hours

  • Cognitive performances assessed using Psychomotor vigilance task (PVT)

    Psychomotor vigilance task (PVT)

    up to 56 hours

  • Cognitive performances assessed using Sustained Attention to Response Task (SART)

    Sustained Attention to Response Task (SART)

    up to 56 hours

  • Cognitive performances assessed using Digit Symbol Substitution Test (DSST)

    Digit Symbol Substitution Test (DSST)

    up to 56 hours

  • Cognitive performances assessed using N-back tasks

    N-back tasks

    up to 56 hours

  • Cognitive performances assessed using Paced Visual Serial Addition Task (PVSAT)

    Paced Visual Serial Addition Task (PVSAT)

    up to 56 hours

  • Cognitive performances assessed using Visual analogue scales (VAS) for motivation

    Visual analogue scales (VAS) for motivation

    up to 56 hours

  • Cognitive performances assessed using Positive and Negative Affect Scale (PANAS)

    Positive and Negative Affect Scale (PANAS)

    up to 56 hours

  • Cognitive performances assessed using Karolinska Sleepiness Scale (KSS)

    Karolinska Sleepiness Scale (KSS)

    up to 56 hours

  • Cognitive performances assessed using Visual Comfort Scale (VCS)

    Visual Comfort Scale (VCS)

    up to 56 hours

  • Cognitive performances assessed using Racing and Crowded Thoughts Questionnaire (RCTQ)

    Racing and Crowded Thoughts Questionnaire (RCTQ)

    up to 56 hours

  • Cognitive performances assessed using Mental Effort Rating Scale (RSME)

    Mental Effort Rating Scale (RSME)

    up to 56 hours

  • Cognitive performances assessed using Karolinska Drowsiness Test (KDT)

    Karolinska Drowsiness Test (KDT)

    up to 56 hours

Study Arms (4)

white polychromatic light A

EXPERIMENTAL
Other: Application of white polychromatic light for 2h30 at different times of day

white polychromatic light B

EXPERIMENTAL
Other: Application of white polychromatic light for 2h30 at different times of day

white polychromatic light C

EXPERIMENTAL
Other: Application of white polychromatic light for 2h30 at different times of day

white polychromatic light D

EXPERIMENTAL
Other: Application of white polychromatic light for 2h30 at different times of day

Interventions

white polychromatic light Awhite polychromatic light Bwhite polychromatic light Cwhite polychromatic light D

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Male or female
  • Aged 18 to 40 years
  • With a hint of Bodymass index (BMI) between 17 and 30 kg.m - 2
  • Healthy subject determined by a clinical examination, a psychological interview, a blood test, a urine analysis and an ophthalmologic examination
  • Topic Subject with a score \<6 questionnaire PSQI ("Sleep Questionnaire Pittsburgh")
  • Subject agreeing to maintain a regular sleep/wake rhythm during the study
  • Subject agreeing to refrain from caffeine, nicotine, alcohol, psychotropic drugs, cannabis or other drugs during the study
  • Signed informed consent
  • Subject affiliated to a social protection scheme

You may not qualify if:

  • somatic diseases: cardiovascular, respiratory, gastrointestinal, hematopoietic, Visual
  • immune system diseases
  • kidneys and urinary tract diseases
  • endocrine and metabolic diseases
  • neurological diseases
  • infectious diseases
  • thrombocytopenia or other malfunction of blood platelets
  • Subject with risk of thrombosis, including subject with a history of phlebitis, smoker under oral contraceptive...
  • Subject with an addiction to caffeine, nicotine, alcohol, psychotropic drugs, cannabis, or any other drug
  • Subject treatment contraindicated or inadvisable in combination with heparin
  • Allergy to neoprene or lycra
  • Dysfunction of the temporomandibular joint (TMJD)
  • Contraindications to the use of the medical device
  • Impossibility to give enlightened information (subject in an emergency situation, understanding difficulties,...)
  • Subject under safeguard of justice
  • +3 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hôpitaux Universitaires de Strasbourg

Strasbourg, 67091, France

Location

Related Publications (2)

  • Glacet R, Reynaud E, Robin-Choteau L, Reix N, Hugueny L, Ruppert E, Geoffroy PA, Kilic-Huck U, Comtet H, Bourgin P. A comparison of four methods to estimate dim light melatonin onset: a repeatability and agreement study. Chronobiol Int. 2023 Feb;40(2):123-131. doi: 10.1080/07420528.2022.2150554. Epub 2022 Dec 15.

  • Walter A, Martz E, Weiner L, Comtet H, Glacet R, Kilic-Huck U, Bourgin P, Schroder CM, Weibel S. Sleep, rest-activity rhythm, cognitive and emotional symptoms in adult ADHD: unraveling the links with an actimetry-based approach. BMC Psychiatry. 2026 Mar 9. doi: 10.1186/s12888-026-07947-9. Online ahead of print.

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 30, 2016

First Posted

August 8, 2016

Study Start

June 1, 2016

Primary Completion

June 1, 2019

Study Completion

June 1, 2019

Last Updated

December 19, 2025

Record last verified: 2025-12

Data Sharing

IPD Sharing
Will not share

Locations