CompletedNot Applicable

Systematically Assessing Effects of Colored Light on Humans With a Multi-modal Approach (Substudy 1 of 7)

Switzerland50 participantsStarted 2017-03-09

Plain-language summary

NOTE: This is the first of in total 7 sub-studies related to the Ethics Committee of the Canton of Bern Ref. No. KEK-BE 2016-00674. This sub-study includes 50 participants and 5 arms, in total 350 participants will be assessed in all 7 sub-studies. General study information: This is a randomized, cross-over, quantitative study, which investigates physiological variables, mood, and affect of healthy participants in response to colored light exposure. The Participants take part in 5-8 arms and are exposed to colored light only, or are additionally asked to solve cognitive tasks during the colored light exposure. Primary aim is to measure the change in several physiological variables, mood, and affect during colored light exposure of 15 or 45 minutes. The risk for the participants is negligible and comparable to the risk during daily life.

Who can participate

Age range18 Years – 50 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Normal color vision * Right handed * Written informed consent Exclusion Criteria: * Smoking * Any kind of diagnosed sleep disorder or neurological or psychiatric disorder in the last 3 months * Acute severe traumas * Chronic diseases with the necessity for medication * Use of recreational drugs * Regular intake of medication that would affect the outcome measures * Regular excessive alcohol use (\> 18 standard units / week) * Transmeridian travel in the last month (crossed \> 1 time zone border) * Night shift word during the last month

What they're measuring

Change in cerebral tissue oxygen saturation during colored light exposure compared with a baseline and a recovery period

Timeframe: 43 minutes (8 min baseline, 15 min colored light exposure, 20 min recovery)

Change in cerebral hemoglobin concentration during colored light exposure compared with a baseline and a recovery period

Timeframe: 43 minutes (8 min baseline, 15 min colored light exposure, 20 min recovery)

Change in variables of the heart rate variability during colored light exposure compared with a baseline and a recovery period

Timeframe: 43 minutes (8 min baseline, 15 min colored light exposure, 20 min recovery)

Change in variables of the electro-dermal activity during colored light exposure compared with a baseline and a recovery period

Timeframe: 43 minutes (8 min baseline, 15 min colored light exposure, 20 min recovery)

Change of the blood pressure during colored light exposure compared with a baseline and a recovery period

Timeframe: 43 minutes (8 min baseline, 15 min colored light exposure, 20 min recovery)

Change of the partial pressure of carbon dioxide during colored light exposure compared with a baseline and a recovery period

Timeframe: 43 minutes (8 min baseline, 15 min colored light exposure, 20 min recovery)

Trial details

NCT IDNCT02882516

SponsorUniversity of Bern

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2017-10-31

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