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Exposure to Man-made Visible LightNCT02882516

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

A study testing Visible light exposure in people with Exposure to Man-made Visible Light, run by University of Bern at 1 site in Switzerland.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 to 50 yearsHealthy volunteers can take part
Conditions the study is for
Exposure to Man-made Visible Light
What is being tested?
Visible light exposure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
50 participants
Where
1 siteSwitzerland
Study dates
9 Mar 2017to 31 Aug 2021
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 50 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Normal color vision
  • Right handed
  • Written informed consent

Who cannot join

  • 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
Show all 9Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

Switzerland1 site

  • University of Bern, Institute of Complementary Medicine

    Bern, 3012

Other trials in Switzerland

About this study

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

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.

Being tested
Visible light exposure
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
Medical subject headings
Respiratory Aspiration

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Visible light exposureOther

    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 groups in NCT02882516
Study groupRoleWhat they receive
Visible light exposure Red 30 luxExperimentalThe participants will be exposed to red 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.
Receives: Other: Visible light exposure
Visible light exposure Red 120 luxExperimentalThe participants will be exposed to red 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.
Receives: Other: Visible light exposure
Visible light exposure Blue 30 luxExperimentalThe participants will be exposed to blue 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.
Receives: Other: Visible light exposure
Visible light exposure Blue 120 luxExperimentalThe participants will be exposed to blue 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.
Receives: Other: Visible light exposure
darknessNo interventionThe participants will not be exposed to any light but stay in darkness for 15 minutes. The colored light exposure will be preceded by sitting 8 minutes in darkness and followed by sitting 20 minutes in darkness.

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: 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

    3 hemoglobin concentrations will be analyzed: of oxygenated hemoglobin, of deoxygenated hemoglobin, and of total hemoglobin.

    Measured: 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

    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.

    Measured: 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

    The tonic and phasic parts of the electro-dermal activity will be analyzed.

    Measured: 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

    The systolic, diastolic, and mean arterial pressure will be analyzed.

    Measured: 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

    The partial pressure of carbon dioxide will be assessed by the end-tidal partial pressure of carbon dioxide of the exhalation air.

    Measured: 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

    Measured: 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

    Measured: 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

    The pulse-respiratory quotient will be calculated as heart rate divided by the respiration rate.

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

  10. Change of the arterial oxygen saturation during colored light exposure compared with a baseline and a recovery period

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Aug 2016 (estimated)
  2. Study start9 Mar 2017
  3. Primary completion31 Oct 2017
  4. Study completion31 Aug 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Basic science
Allocation
Randomised
Intervention model
Crossover
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
50 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02882516
Sponsor's protocol ID
COLOR10_a
Status last verified
Sep 2021
First submitted
24 Aug 2016
Last updated
17 Sep 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided: 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.

Publications

  • 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.

    PubMed 22259078

  • 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.

    PubMed 21666991

Questions about this trial

What is this clinical trial studying?

A study testing Visible light exposure in people with Exposure to Man-made Visible Light, run by University of Bern at 1 site in Switzerland.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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)). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02882516, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Sep 2021.

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