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Completed

NCT Number: NCT02858765

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

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.

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Key information

Age range

18 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hôpitaux Universitaires de Strasbourg

Strasbourg, 67091, France

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Other

Primary outcomes

  1. Analysis of EEG activity

    Time frame: up to 56 hours

    sleep fragmentation

  2. Cognitive performances assessed using Psychomotor vigilance task (PVT)

    Time frame: up to 56 hours

    Psychomotor vigilance task (PVT)

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

    Time frame: up to 56 hours

    Sustained Attention to Response Task (SART)

  4. Cognitive performances assessed using Digit Symbol Substitution Test (DSST)

    Time frame: up to 56 hours

    Digit Symbol Substitution Test (DSST)

  5. Cognitive performances assessed using N-back tasks

    Time frame: up to 56 hours

    N-back tasks

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

    Time frame: up to 56 hours

    Paced Visual Serial Addition Task (PVSAT)

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

    Time frame: up to 56 hours

    Visual analogue scales (VAS) for motivation

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

    Time frame: up to 56 hours

    Positive and Negative Affect Scale (PANAS)

  9. Cognitive performances assessed using Karolinska Sleepiness Scale (KSS)

    Time frame: up to 56 hours

    Karolinska Sleepiness Scale (KSS)

  10. Cognitive performances assessed using Visual Comfort Scale (VCS)

    Time frame: up to 56 hours

    Visual Comfort Scale (VCS)

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

    Time frame: up to 56 hours

    Racing and Crowded Thoughts Questionnaire (RCTQ)

  12. Cognitive performances assessed using Mental Effort Rating Scale (RSME)

    Time frame: up to 56 hours

    Mental Effort Rating Scale (RSME)

  13. Cognitive performances assessed using Karolinska Drowsiness Test (KDT)

    Time frame: up to 56 hours

    Karolinska Drowsiness Test (KDT)

Sponsors and collaborators

Lead sponsor

University Hospital, Strasbourg, France

Other

Registry information

Official study title

Influence of Light on Sleep, Awakening, Electroencephalogram (EEG) and Cognitive Performances, and Medical Technology Assessment for Registration and Long-term EEG Analysis

Acronym: CHRONOSOMNO

Important dates

Study start
2016
Primary completion
2019
Study completion
2019
First posted
Aug 8, 2016
Registry last updated
Dec 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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