Clinical trial NCT02882516: Systematically Assessing Effects of Colored Light on Humans With a Multi-modal Approach (Substudy 1 of 7)
Official title: Systematically Assessing Effects of Colored Light on Humans With a Multi-modal Approach
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Exposure to Man-made Visible Light
Keywords: cerebral oxygen metabolism
functional near-infrared spectroscopy
partial pressure of carbon dioxide
heart rate variability
blood pressure
affect
mood
respiration
systematic randomized cross-over study
systemic physiology
electro-dermal activity
pulse-respiratory quotient
Lead sponsor: University of Bern
Sponsor class: OTHER
First posted: 2016-08-30
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: 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)
measure: 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)
measure: 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)
measure: 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)
measure: 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)
measure: 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)
measure: Change of the respiration rate 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)
measure: Change of the heart rate 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)
measure: Change of the pulse-respiratory quotient 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)
measure: Change of the arterial 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)
Secondary outcomes:
Other outcomes:
Locations:
city: Bern
country: Switzerland
facility: University of Bern, Institute of Complementary Medicine
Study officials:
affiliation: University of Bern
name: Ursula Wolf, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Weinzirl J, Wolf M, Nelle M, Heusser P, Wolf U. Colored light and brain and muscle oxygenation. Adv Exp Med Biol. 2012;737:33-6. doi: 10.1007/978-1-4614-1566-4_5. No abstract available.
citation: Weinzirl J, Wolf M, Heusser P, Nelle M, Wolf U. Effects of changes in colored light on brain and calf muscle blood concentration and oxygenation. ScientificWorldJournal. 2011 Jun 9;11:1216-25. doi: 10.1100/tsw.2011.118.