ClinicalTrials.Veeva

Menu

Influence of Light on Sleep, Awakening, Electroencephalogram (EEG) and Cognitive Performances (CHRONOSOMNO)

U

University Hospital, Strasbourg, France

Status

Completed

Conditions

Human Sleep and Chronobiology

Treatments

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

Study type

Interventional

Funder types

Other

Identifiers

Details and patient eligibility

About

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.

Enrollment

92 patients

Sex

All

Ages

18 to 40 years old

Volunteers

Accepts Healthy Volunteers

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 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

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
  • Allergy to neoprene or lycra
  • Dysfunction of the temporomandibular joint (TMJD)
  • Blood donation in the previous 3 months before the inclusion
  • Participation in other clinical trials in the previous 3 months before the inclusion
  • Work by shifts in the year preceding the inclusion
  • Trans-meridian travel (> 2 time zones) in the month previous the inclusion
  • 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
  • Subject under tutorship or curatorship
  • Pregnancy (women of childbearing age)
  • Breastfeeding

Trial design

Primary purpose

Basic Science

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

92 participants in 4 patient groups

white polychromatic light A
Experimental group
Treatment:
Other: Application of white polychromatic light for 2h30 at different times of day
white polychromatic light B
Experimental group
Treatment:
Other: Application of white polychromatic light for 2h30 at different times of day
white polychromatic light C
Experimental group
Treatment:
Other: Application of white polychromatic light for 2h30 at different times of day
white polychromatic light D
Experimental group
Treatment:
Other: Application of white polychromatic light for 2h30 at different times of day

Trial contacts and locations

1

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2024 Veeva Systems