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

NCT ID: NCT05232383

Last Updated: 2025-08-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

96 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-12-02

Study Completion Date

2026-05-01

Brief Summary

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

Detailed Description

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Conditions

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Human Sleep and Chronobiology

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Wp

Group Type ACTIVE_COMPARATOR

polychromatic light

Intervention Type DEVICE

Application of polychromatic light at different times of day

Wn

Group Type ACTIVE_COMPARATOR

polychromatic light

Intervention Type DEVICE

Application of polychromatic light for 2h30 at different times of day with sleep

Gn

Group Type ACTIVE_COMPARATOR

green light

Intervention Type DEVICE

Application of green light at different times of day with sleep

Gp

Group Type ACTIVE_COMPARATOR

green light

Intervention Type DEVICE

Application of green light at different times of day

Rp

Group Type ACTIVE_COMPARATOR

red light

Intervention Type DEVICE

Application of red light at different times of day

Rn

Group Type ACTIVE_COMPARATOR

red light

Intervention Type DEVICE

Application of red light at different times of day with sleep

Interventions

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polychromatic light

Application of polychromatic light at different times of day

Intervention Type DEVICE

polychromatic light

Application of polychromatic light for 2h30 at different times of day with sleep

Intervention Type DEVICE

red light

Application of red light at different times of day

Intervention Type DEVICE

red light

Application of red light at different times of day with sleep

Intervention Type DEVICE

green light

Application of green light at different times of day

Intervention Type DEVICE

green light

Application of green light at different times of day with sleep

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University Hospital, Strasbourg, France

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Patrice BOURGIN, MD

Role: PRINCIPAL_INVESTIGATOR

Hôpitaux Universitaires de Strasbourg

Locations

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Hôpitaux Universitaires de Strasbourg

Strasbourg, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Patrice BOURGIN, MD

Role: CONTACT

03 88 11 64 30 ext. 0033

Facility Contacts

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Patrice BOURGIN, MD

Role: primary

03 88 11 64 30

Other Identifiers

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8076

Identifier Type: -

Identifier Source: org_study_id

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