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Clinical Trials/NCT05232383
NCT05232383
Recruiting
Not Applicable

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

University Hospital, Strasbourg, France1 site in 1 country96 target enrollmentDecember 2, 2021
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ConditionsHuman Sleep and Chronobiology

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Human Sleep and Chronobiology
Sponsor
University Hospital, Strasbourg, France
Enrollment
96
Locations
1
Primary Endpoint
Cognitive performances assessed using Paced Visual Serial Addition Task (PVSAT)
Status
Recruiting
Last Updated
8 months ago
OverviewInvestigatorsEligibility CriteriaOutcomesSitesSimilar Trials

Overview

Brief Summary

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

Registry
clinicaltrials.gov
Start Date
December 2, 2021
End Date
May 1, 2026
Last Updated
8 months ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
University Hospital, Strasbourg, France
Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

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

Time Frame: up to 56 hours

Paced Visual Serial Addition Task (PVSAT)

Cognitive performances assessed using Psychomotor Vigilance task (PVT)

Time Frame: up to 56 hours

Psychomotor Vigilance task (PVT)

Cognitive performances assessed using N-back tasks

Time Frame: up to 56 hours

N-Back-Task 1, 2, 3

Study Sites (1)

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