Clincosm LogoSign in Get a demo

LumEnColor: Benefits and Risks of Artificial Light Exposure: Characterisation of Effects on Alertness, Sleep, Cognitive Performance, Mood and Biological Rhythms

Sponsor
University Hospital, Strasbourg, France (Other)
Overall Status
Recruiting
CT.gov ID
NCT05232383
Collaborator
(none)
96
Enrollment
1
Location
6
Arms
28.9
Anticipated Duration (Months)
3.3
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this project is to study the influence of light on sleep, wakefulness, EEG activity and cognitive performances.

Condition or Disease Intervention/Treatment Phase
  • Device: polychromatic light
  • Device: polychromatic light
  • Device: red light
  • Device: red light
  • Device: green light
  • Device: green light
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
96 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Basic Science
Official Title:
Benefits and Risks of Artificial Light Exposure: Characterisation of Effects on Alertness, Sleep, Cognitive Performance, Mood and Biological Rhythms
Actual Study Start Date :
Dec 2, 2021
Anticipated Primary Completion Date :
Apr 2, 2024
Anticipated Study Completion Date :
May 1, 2024

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Wp

Device: polychromatic light
Application of polychromatic light at different times of day
Active Comparator: Wn

Device: polychromatic light
Application of polychromatic light for 2h30 at different times of day with sleep
Active Comparator: Gn

Device: green light
Application of green light at different times of day with sleep
Active Comparator: Gp

Device: green light
Application of green light at different times of day
Active Comparator: Rp

Device: red light
Application of red light at different times of day
Active Comparator: Rn

Device: red light
Application of red light at different times of day with sleep

Outcome Measures

Primary Outcome Measures

  1. Cognitive performances assessed using N-back tasks [up to 56 hours]

    N-Back-Task 1, 2, 3

  2. Cognitive performances assessed using Psychomotor Vigilance task (PVT) [up to 56 hours]

    Psychomotor Vigilance task (PVT)

  3. Cognitive performances assessed using Paced Visual Serial Addition Task (PVSAT) [up to 56 hours]

    Paced Visual Serial Addition Task (PVSAT)

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 40 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:

  • 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

  • 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

  • Subjectaffiliated to a social protection scheme

Exclusion Criteria:

  • 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

  • blood donation in the previous 3 months before the inclusion

  • Participation in other clinical trials

  • Work by shifts in the year preceding the inclusion

  • Trans-meridian travel (> 2 time zones) in the month previous the inclusion

  • Impossibility to give enlightened information (subject in an emergency situation, understanding difficulties,...)

  • Subject under safeguard of justice

  • Subject under tutorship or curatorship

  • Pregnancy (women of childbearing age)

  • Breastfeeding

  • Diet incompatible with the study's snack choices

Contacts and Locations

Locations

Site City State Country Postal Code
1 Hôpitaux Universitaires de Strasbourg Strasbourg France 67091

Sponsors and Collaborators

  • University Hospital, Strasbourg, France

Investigators

  • Principal Investigator: Patrice BOURGIN, MD, Hôpitaux Universitaires de Strasbourg

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
University Hospital, Strasbourg, France
ClinicalTrials.gov Identifier:
NCT05232383
Other Study ID Numbers:
  • 8076
First Posted:
Feb 9, 2022
Last Update Posted:
Jul 8, 2022
Last Verified:
Jul 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Jul 8, 2022