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

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ClinicalTrials.gov Identifier: NCT02919137
Recruitment Status : Not yet recruiting
First Posted : September 29, 2016
Last Update Posted : October 17, 2018
Sponsor:
Information provided by (Responsible Party):
University of Bern

Brief Summary:

NOTE: This is the seventh 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 8 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.


Condition or disease Intervention/treatment Phase
Exposure to Man-made Visible Light Other: Visible light exposure Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: Systematically Assessing Effects of Colored Light on Humans With a Multi-modal Approach
Estimated Study Start Date : September 1, 2019
Estimated Primary Completion Date : July 31, 2021
Estimated Study Completion Date : July 31, 2021

Arm Intervention/treatment
Experimental: Visible light exposure Red 30 lux
The participants will be exposed to red LED light at a illuminance of 30 lux at eye level for 45 minutes. The colored light exposure will be preceded by sitting 8 minutes in darkness and followed by sitting 20 minutes in darkness. The participants will perform cognitive tests (verbal fluency task, arithmetic task, word repetition task) during the colored light exposure and hyperventilation and hypoventilation tasks .
Other: Visible light exposure
Subjects will be exposed to visible colored light for 45 minutes. The visible light will be generated by red-green-blue light emitting diodes light cans.

Experimental: Visible light exposure Red 120 lux
The participants will be exposed to red LED light at a illuminance of 120 lux at eye level for 45 minutes. The colored light exposure will be preceded by sitting 8 minutes in darkness and followed by sitting 20 minutes in darkness. The participants will perform cognitive tests (verbal fluency task, arithmetic task, word repetition task) during the colored light exposure and hyperventilation and hypoventilation tasks .
Other: Visible light exposure
Subjects will be exposed to visible colored light for 45 minutes. The visible light will be generated by red-green-blue light emitting diodes light cans.

Experimental: Visible light exposure Blue 30 lux
The participants will be exposed to blue LED light at a illuminance of 30 lux at eye level for 45 minutes. The colored light exposure will be preceded by sitting 8 minutes in darkness and followed by sitting 20 minutes in darkness. The participants will perform cognitive tests (verbal fluency task, arithmetic task, word repetition task) during the colored light exposure and hyperventilation and hypoventilation tasks .
Other: Visible light exposure
Subjects will be exposed to visible colored light for 45 minutes. The visible light will be generated by red-green-blue light emitting diodes light cans.

Experimental: Visible light exposure Blue 120 lux
The participants will be exposed to blue LED light at a illuminance of 120 lux at eye level for 45 minutes. The colored light exposure will be preceded by sitting 8 minutes in darkness and followed by sitting 20 minutes in darkness. The participants will perform cognitive tests (verbal fluency task, arithmetic task, word repetition task) during the colored light exposure and hyperventilation and hypoventilation tasks .
Other: Visible light exposure
Subjects will be exposed to visible colored light for 45 minutes. The visible light will be generated by red-green-blue light emitting diodes light cans.

Experimental: Visible light exposure Green 30 lux
The participants will be exposed to green LED light at a illuminance of 30 lux at eye level for 45 minutes. The colored light exposure will be preceded by sitting 8 minutes in darkness and followed by sitting 20 minutes in darkness. The participants will perform cognitive tests (verbal fluency task, arithmetic task, word repetition task) during the colored light exposure and hyperventilation and hypoventilation tasks .
Other: Visible light exposure
Subjects will be exposed to visible colored light for 45 minutes. The visible light will be generated by red-green-blue light emitting diodes light cans.

Experimental: Visible light exposure Green 120 lux
The participants will be exposed to green LED light at a illuminance of 120 lux at eye level for 45 minutes. The colored light exposure will be preceded by sitting 8 minutes in darkness and followed by sitting 20 minutes in darkness. The participants will perform cognitive tests (verbal fluency task, arithmetic task, word repetition task) during the colored light exposure and hyperventilation and hypoventilation tasks .
Other: Visible light exposure
Subjects will be exposed to visible colored light for 45 minutes. The visible light will be generated by red-green-blue light emitting diodes light cans.

Experimental: Visible light exposure White 30 lux
The participants will be exposed to white LED light at a illuminance of 30 lux at eye level for 45 minutes. The colored light exposure will be preceded by sitting 8 minutes in darkness and followed by sitting 20 minutes in darkness. The participants will perform cognitive tests (verbal fluency task, arithmetic task, word repetition task) during the colored light exposure and hyperventilation and hypoventilation tasks .
Other: Visible light exposure
Subjects will be exposed to visible colored light for 45 minutes. The visible light will be generated by red-green-blue light emitting diodes light cans.

Experimental: Visible light exposure White 120 lux
The participants will be exposed to white LED light at a illuminance of 120 lux at eye level for 45 minutes. The colored light exposure will be preceded by sitting 8 minutes in darkness and followed by sitting 20 minutes in darkness. The participants will perform cognitive tests (verbal fluency task, arithmetic task, word repetition task) during the colored light exposure and hyperventilation and hypoventilation tasks .
Other: Visible light exposure
Subjects will be exposed to visible colored light for 45 minutes. The visible light will be generated by red-green-blue light emitting diodes light cans.




Primary Outcome Measures :
  1. Change in cerebral tissue oxygen saturation during colored light exposure compared with a baseline and a recovery period [ Time Frame: 43 minutes (8 min baseline, 15 min colored light exposure, 20 min recovery) ]
  2. Change in cerebral hemoglobin concentration during colored light exposure compared with a baseline and a recovery period [ Time Frame: 43 minutes (8 min baseline, 15 min colored light exposure, 20 min recovery) ]
  3. Change in variables of the heart rate variability during colored light exposure compared with a baseline and a recovery period [ Time Frame: 43 minutes (8 min baseline, 15 min colored light exposure, 20 min recovery) ]
  4. Change in variables of the electro-dermal activity during colored light exposure compared with a baseline and a recovery period [ Time Frame: 43 minutes (8 min baseline, 15 min colored light exposure, 20 min recovery) ]
  5. Change of the blood pressure during colored light exposure compared with a baseline and a recovery period [ Time Frame: 43 minutes (8 min baseline, 15 min colored light exposure, 20 min recovery) ]
  6. Change of the partial pressure of carbon dioxide during colored light exposure compared with a baseline and a recovery period [ Time Frame: 43 minutes (8 min baseline, 15 min colored light exposure, 20 min recovery) ]
  7. Change of the respiration rate during colored light exposure compared with a baseline and a recovery period [ Time Frame: 43 minutes (8 min baseline, 15 min colored light exposure, 20 min recovery) ]
  8. Change of the heart rate during colored light exposure compared with a baseline and a recovery period [ Time Frame: 43 minutes (8 min baseline, 15 min colored light exposure, 20 min recovery) ]
  9. Change of the pulse-respiratory quotient during colored light exposure compared with a baseline and a recovery period [ Time Frame: 43 minutes (8 min baseline, 15 min colored light exposure, 20 min recovery) ]
    The pulse-respiratory quotient will be calculated as heart rate divided by the respiration rate.

  10. Change of the arterial oxygen saturation during colored light exposure compared with a baseline and a recovery period [ Time Frame: 43 minutes (8 min baseline, 15 min colored light exposure, 20 min recovery) ]

Secondary Outcome Measures :
  1. Change in verbal fluency task performance during exposure to different colors. [ Time Frame: 1-4 weeks ]
    A word repetition task will serve as control condition.

  2. Change in arithmetic task performance during exposure to different colors. [ Time Frame: 1-4 weeks ]
    A word repetition task will serve as control condition.

  3. Difference in brain activity evoked from the verbal fluency task for the different colored light conditions. [ Time Frame: 1-4 weeks ]
    A word repetition task will serve as control condition.

  4. Difference in brain activity evoked from the arithmetic task for the different colored light conditions. [ Time Frame: 1-4 weeks ]
    A word repetition task will serve as control condition.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02919137


Contacts
Contact: Ursula Wolf, Prof. Dr. +41 31 631 8140 ursula.wolf@ikom.unibe.ch

Locations
Switzerland
University of Bern, Institute of Complementary Medicine Not yet recruiting
Bern, Switzerland, 3012
Contact: Ursula Wolf, Prof. Dr.         
Sponsors and Collaborators
University of Bern
Investigators
Principal Investigator: Ursula Wolf, Prof. Dr. University of Bern

Additional Information:
Publications:
Responsible Party: University of Bern
ClinicalTrials.gov Identifier: NCT02919137     History of Changes
Other Study ID Numbers: COLOR10_g
First Posted: September 29, 2016    Key Record Dates
Last Update Posted: October 17, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: Access to research data and documents will be handled according to the Manifesto to advance Data Access and Research Transparency (DART) in Switzerland, formulated at the workshop on "Improving DART in Switzerland" in Bern, November 7th, 2014.

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University of Bern:
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