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Systematically Assessing Effects of Colored Light on Humans With a Multi-modal Approach (Substudy 2 of 7)

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ClinicalTrials.gov Identifier: NCT02882529
Recruitment Status : Recruiting
First Posted : August 30, 2016
Last Update Posted : February 15, 2019
Sponsor:
Information provided by (Responsible Party):
University of Bern

Tracking Information
First Submitted Date  ICMJE August 24, 2016
First Posted Date  ICMJE August 30, 2016
Last Update Posted Date February 15, 2019
Actual Study Start Date  ICMJE June 26, 2017
Estimated Primary Completion Date January 1, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 24, 2016)
  • 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) ]
  • 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 hemoglobin concentrations will be analyzed: of oxygenated hemoglobin, of deoxygenated hemoglobin, and of total hemoglobin.
  • 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) ]
    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.
  • 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) ]
    The tonic and phasic parts of the electro-dermal activity will be analyzed.
  • 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) ]
    The systolic, diastolic, and mean arterial pressure will be analyzed.
  • 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) ]
    The partial pressure of carbon dioxide will be assessed by the end-tidal partial pressure of carbon dioxide of the exhalation air.
  • 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) ]
  • 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) ]
  • 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.
  • 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) ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02882529 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Systematically Assessing Effects of Colored Light on Humans With a Multi-modal Approach (Substudy 2 of 7)
Official Title  ICMJE Systematically Assessing Effects of Colored Light on Humans With a Multi-modal Approach
Brief Summary

NOTE: This is the second 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 6 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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Basic Science
Condition  ICMJE Exposure to Man-made Visible Light
Intervention  ICMJE 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.
Study Arms  ICMJE
  • 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 15 minutes. The colored light exposure will be preceded by sitting 8 minutes in darkness and followed by sitting 20 minutes in darkness.
    Intervention: Other: Visible light exposure
  • 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 15 minutes. The colored light exposure will be preceded by sitting 8 minutes in darkness and followed by sitting 20 minutes in darkness.
    Intervention: Other: Visible light exposure
  • Experimental: Visible light exposure Yellow 30 lux
    The participants will be exposed to yellow LED light at a illuminance of 30 lux at eye level for 15 minutes. The colored light exposure will be preceded by sitting 8 minutes in darkness and followed by sitting 20 minutes in darkness.
    Intervention: Other: Visible light exposure
  • Experimental: Visible light exposure Yellow 120 lux
    The participants will be exposed to yellow LED light at a illuminance of 120 lux at eye level for 15 minutes. The colored light exposure will be preceded by sitting 8 minutes in darkness and followed by sitting 20 minutes in darkness.
    Intervention: Other: Visible light exposure
  • Experimental: Visible light exposure Violet 30 lux
    The participants will be exposed to violet LED light at a illuminance of 30 lux at eye level for 15 minutes. The colored light exposure will be preceded by sitting 8 minutes in darkness and followed by sitting 20 minutes in darkness.
    Intervention: Other: Visible light exposure
  • Experimental: Visible light exposure Violet 120 lux
    The participants will be exposed to violet LED light at a illuminance of 120 lux at eye level for 15 minutes. The colored light exposure will be preceded by sitting 8 minutes in darkness and followed by sitting 20 minutes in darkness.
    Intervention: Other: Visible light exposure
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: August 24, 2016)
50
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 26, 2021
Estimated Primary Completion Date January 1, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 50 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Ursula Wolf, Prof. Dr. 031 631 8140 ursula.wolf@ikom.unibe.ch
Contact: Barbara Casanova barbara.casanova@ikom.unibe.ch
Listed Location Countries  ICMJE Switzerland
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02882529
Other Study ID Numbers  ICMJE COLOR10_b
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
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.
Responsible Party University of Bern
Study Sponsor  ICMJE University of Bern
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Ursula Wolf, Prof. Dr. University of Bern
PRS Account University of Bern
Verification Date February 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP