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

Exposure to Man-made Visible Light Clinical Trial

Official title:

Systematically Assessing Effects of Colored Light on Humans With a Multi-modal Approach

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02882516
• Other study ID #: COLOR10_a
• Status: Completed
• Phase: N/A
• Start date: March 9, 2017
• Est. completion date: August 31, 2021

Study information

• Verified date: September 2021
• Source: University of Bern
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: August 31, 2021
• Est. primary completion date: October 31, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Exposure to Man-made Visible Light

Intervention

Other:
• Visible light exposure
Subjects will be exposed to visible colored light for 15 minutes. The visible light will be generated by red-green-blue light emitting diodes light cans.

Locations

Country	Name	City	State
Switzerland	University of Bern, Institute of Complementary Medicine	Bern

Sponsors (1)

Lead Sponsor	Collaborator
University of Bern

Country where clinical trial is conducted

Switzerland, 

References & Publications (2)

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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in cerebral tissue oxygen saturation during colored light exposure compared with a baseline and a recovery period		43 minutes (8 min baseline, 15 min colored light exposure, 20 min recovery)
Primary	Change in cerebral hemoglobin concentration during colored light exposure compared with a baseline and a recovery period	3 hemoglobin concentrations will be analyzed: of oxygenated hemoglobin, of deoxygenated hemoglobin, and of total hemoglobin.	43 minutes (8 min baseline, 15 min colored light exposure, 20 min recovery)
Primary	Change in variables of the heart rate variability during colored light exposure compared with a baseline and a recovery period	Heart rate variability variables are: the standard deviation of the NN Intervals (SDNN), the square root of the mean of the sum of the squares of differences between adjacent NN intervals (RMSSD), the power of the high-frequency component (HF, 0.15-0.4 Hz), the power of the low-frequency component (LF, 0.04-0.15 Hz), the power of the very low-frequency component (VLF, <0.04 Hz), normalized LF and HF components, and the LF/HF ratio.	43 minutes (8 min baseline, 15 min colored light exposure, 20 min recovery)
Primary	Change in variables of the electro-dermal activity during colored light exposure compared with a baseline and a recovery period	The tonic and phasic parts of the electro-dermal activity will be analyzed.	43 minutes (8 min baseline, 15 min colored light exposure, 20 min recovery)
Primary	Change of the blood pressure during colored light exposure compared with a baseline and a recovery period	The systolic, diastolic, and mean arterial pressure will be analyzed.	43 minutes (8 min baseline, 15 min colored light exposure, 20 min recovery)
Primary	Change of the partial pressure of carbon dioxide during colored light exposure compared with a baseline and a recovery period	The partial pressure of carbon dioxide will be assessed by the end-tidal partial pressure of carbon dioxide of the exhalation air.	43 minutes (8 min baseline, 15 min colored light exposure, 20 min recovery)
Primary	Change of the respiration rate during colored light exposure compared with a baseline and a recovery period		43 minutes (8 min baseline, 15 min colored light exposure, 20 min recovery)
Primary	Change of the heart rate during colored light exposure compared with a baseline and a recovery period		43 minutes (8 min baseline, 15 min colored light exposure, 20 min recovery)
Primary	Change of the pulse-respiratory quotient during colored light exposure compared with a baseline and a recovery period	The pulse-respiratory quotient will be calculated as heart rate divided by the respiration rate.	43 minutes (8 min baseline, 15 min colored light exposure, 20 min recovery)
Primary	Change of the arterial oxygen saturation during colored light exposure compared with a baseline and a recovery period		43 minutes (8 min baseline, 15 min colored light exposure, 20 min recovery)

External Links

•   Link to further information on the study