Mechanisms of Cone Photoreceptors Contribution on Human Neuroendocrine Physiology and Pupillary Light Responses
试验速览
- 阶段
- 不适用
- 入组人数
- 68
- 试验地点
- 2
- 主要终点
- Melatonin concentration
研究概览
简要总结
The main aim of this study is to investigate the effects of cone-modulated light emitted from a visual display on human circadian physiology and cognitive performance in the evening.
详细描述
The investigators will generate single/multiple cone-isolating contrasts with equivalent stimuli for other cones and melanopsin photoreceptors. The investigators will assess melatonin suppression under three different light scenarios generated using the method of silent substitution by tuning the spectral composition of the light primaries (e.g. LEDs) such that a single target photoreceptor class is maximally stimulated compared to an equal stimulation of the remaining photoreceptors. Additionally, The investigators will examine pupil response, subjective sleepiness, psychomotor vigilance, visual comfort, and skin temperature under three different light scenarios. This allows for new insights into the lights' cone-contribution mechanism to neuroendocrine physiology in the human retina.
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 35 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age: 18 - 35 years
- •Sex: male or female normal color vision, male dichromat (i.e. tested by CCT, HRR, Farnsworth Munsell 100 Hue Test)
- •BMI: 18.5 - 29.9 self-reported weight and height (i.e. normal and overweight according to WHO)
- •Signed consent form of participants
- •Chronotype: Morningness-Eveningness Questionnaire (31 - 69)
- •Sleep Quality: Pittsburgh Sleep Quality Index, PSQI (≤5)
排除标准
- •High myopia (> -6 diopters)
- •High hyperopia (< +6 diopters)
- •Transmeridian travel (>2 time zones) <1 month prior to the first session of the study
- •Shift work <3 months prior to the beginning of the study
- •Ophthalmological or optometric conditions (cataract, glaucoma, retinal detachment, macular conditions, chronic inflammations, eye injuries, or operations)
- •General health concerns or disorders, including heart and cardiovascular, neurological, nephrological, endocrinological, and psychiatric conditions
- •Medication impacting on visual, neuroendocrine, sleep, and circadian physiology
- •For females only: pregnancy, use of hormonal contraceptives, lactation or breastfeeding
- •Drug (urinary drug screening) and alcohol use
- •Non-compliance with sleep-wake times: >1 deviation from ±30 minute window sleep and wake-up time
- •Extreme chronotype (Munich Chronotype Questionnaire <2 or >7)
- •Current participation in other clinical trials
- •Exclusion criteria due to study requirements:
- •Inability to understand and/or follow study materials or procedures
- •Insufficient knowledge of project language
结局指标
主要结局
Melatonin concentration
时间窗: 1 year
The saliva samples will be collected from participants every 30 min. The investigators hypothesize that the cone flickering light stimuli will have a different melatonin-attenuating effect than the constant background stimuli and that both will have a different effect than baseline.
次要结局
- Skin temperature(1 year)
- Subjective sleepiness(1 year)
- Vigilance performance(1 year)
- Pupil response(1 year)
- Visual comfort(1 year)
研究者
Fatemeh Fazlali
Investigator
University of Basel