Systematically Assessing Effects of Colored Light on Humans With a Multi-modal Approach
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Change of the blood pressure during colored light exposure compared with a baseline and a recovery period
研究概览
简要总结
NOTE: This is the sixth 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.
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
结局指标
主要结局
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)
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.
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)
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 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 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 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)
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)
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)
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)
次要结局
未报告次要终点