Systematically Assessing Effects of Colored Light on Humans With a Multi-modal Approach
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Change in variables of the electro-dermal activity during colored light exposure compared with a baseline and a recovery period
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Normal color vision
- •Right handed
- •Written informed consent
排除标准
- •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
研究组 & 干预措施
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.
干预措施: Visible light exposure (Other)
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.
干预措施: Visible light exposure (Other)
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.
干预措施: Visible light exposure (Other)
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.
干预措施: Visible light exposure (Other)
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.
干预措施: Visible light exposure (Other)
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.
干预措施: Visible light exposure (Other)
结局指标
主要结局
Change in variables of the electro-dermal activity during colored light exposure compared with a baseline and a recovery period
时间窗: 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
时间窗: 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 respiration rate during colored light exposure compared with a baseline and a recovery period
时间窗: 43 minutes (8 min baseline, 15 min colored light exposure, 20 min recovery)
Change in cerebral tissue oxygen saturation during colored light exposure compared with a baseline and a recovery period
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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 of the partial pressure of carbon dioxide during colored light exposure compared with a baseline and a recovery period
时间窗: 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 arterial oxygen saturation during colored light exposure compared with a baseline and a recovery period
时间窗: 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
时间窗: 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.
次要结局
未报告次要终点