Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05232383
Other study ID # 8076
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date December 2, 2021
Est. completion date May 1, 2024

Study information

Verified date August 2023
Source University Hospital, Strasbourg, France
Contact Patrice BOURGIN, MD
Phone 03 88 11 64 30
Email pbourgin@unistra.fr
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


Recruitment information / eligibility

Status Recruiting
Enrollment 96
Est. completion date May 1, 2024
Est. primary completion date April 2, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 40 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Device:
polychromatic light
Application of polychromatic light at different times of day
polychromatic light
Application of polychromatic light for 2h30 at different times of day with sleep
red light
Application of red light at different times of day
red light
Application of red light at different times of day with sleep
green light
Application of green light at different times of day
green light
Application of green light at different times of day with sleep

Locations

Country Name City State
France 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 Cognitive performances assessed using N-back tasks N-Back-Task 1, 2, 3 up to 56 hours
Primary Cognitive performances assessed using Psychomotor Vigilance task (PVT) Psychomotor Vigilance task (PVT) up to 56 hours
Primary Cognitive performances assessed using Paced Visual Serial Addition Task (PVSAT) Paced Visual Serial Addition Task (PVSAT) up to 56 hours
See also
  Status Clinical Trial Phase
Completed NCT02858765 - Influence of Light on Sleep, Awakening, Electroencephalogram (EEG) and Cognitive Performances N/A