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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Visible light exposure Red 30 lux | Experimental | The 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. |
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| Visible light exposure Red 120 lux | Experimental | The 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. |
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| Visible light exposure Blue 30 lux | Experimental | The 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. |
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| Visible light exposure Blue 120 lux | Experimental | The 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. |
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| darkness |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Visible light exposure | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | |
| 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) |
| 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) |
| 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) |
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ursula Wolf, Prof. Dr. | University of Bern | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Bern, Institute of Complementary Medicine | Bern | 3012 | Switzerland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22259078 | Background | 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. | |
| 21666991 | Background | 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. |
| Label | URL |
|---|---|
| Link to further information on the study | View source |
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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.
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| ID | Term |
|---|---|
| D053120 | Respiratory Aspiration |
| ID | Term |
|---|---|
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| No Intervention |
The 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. |
| 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) |
| 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) |
| 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) |
| 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) |
| 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) |