Modulating Evening Responses to Light by Afternoon Light Exposure in Adolescents
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 27
- 试验地点
- 2
- 主要终点
- Salivary melatonin
研究概览
简要总结
Many teenagers are familiar with this: on school days, they have to get up early; during the day, they hardly get any light exposure; in the evening, they go to bed late - and are then tired at school the next day! Around the world, teenagers are sleep deprived, with studies suggesting that almost half (~45%) suffer from inadequate sleep. Previous investigations have shown that people's sleep-wake rhythm is related to the light conditions that they are exposed to during the day and at night. However, little is known about how different light levels in the afternoon can modulate teenagers' sleep and their bodily responses to light in the late evening. Therefore, the investigators aim to study which lighting conditions have a favourable effect on these aspects and how the potentially harmful effects of light at night can be prevented.
详细描述
Light exposure during adolescence seems to be the critical component of a vicious circle. Due to the maturation of sleep-wake regulatory systems in combination with progressively ill-timed exposure to light and early school start times, teenagers suffer from the accumulation of sleep depth during school days. Therefore, the proposed study investigates whether the physiological and alerting effects of late evening light exposure in adolescents depend on the intensity of light exposure in the preceding afternoon (primary endpoint: evening melatonin concentration).
The investigators aim to describe dose-response relationships, where the "dose" is the preceding (real-world applicable) afternoon light intensity (< 10 lx, ~100 lx, or >1000 lx EDI, 4-hour duration), and the "responses" are the adolescents' physiological and alerting responses to evening light exposure (~100 lx melanopic EDI, 4.5-hour duration). By this route, the researchers can explore whether increasing afternoon light exposure is a feasible target for ameliorating the detrimental effects of artificial light at night and promoting healthier sleep-wake regulation during adolescence.
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
- None
盲法说明
Entirely blinding the differences between the experiment's light conditions is unattainable (for both participants and experimenters) because of the visibly perceivable differences in brightness between them. However, the melatonin and objective EEG measurements should not be significantly affected by any expectancy effects. Participants will not be told the expected effects of the different light exposure conditions to minimise the expectancy effects for behavioural measures (i.e., PVT) and subjective measurements. Information on the hypothesized outcomes will be withheld from the volunteers and study helpers until after completing all sessions. During the analysis, light intensity conditions and participant IDs will be coded to withhold information from the analytic team about the light intensity.
入排标准
- 年龄范围
- 14 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Capable of judgment
- •Normal BMI (Age-related Body-Mass-Index Percentile > P3 & < P97; approx. corresponding to 28.5 ≥ BMI ≤ 16)
- •Signed consent form of participants
- •Signed consent form of a legal representative
排除标准
- •Pregnancy or breastfeeding (only female)
- •Current participation in other clinical trials
- •Extreme chronotype (Extreme early or late chronotype/mid sleep time: mid-sleep time < 1:00 / > 7:00)
- •Extremely short or long sleep durations during school- or work days (< 6 hours > 11 hours)
- •Sleep disorders
- •High myopia (< -6 diopters)
- •High hyperopia (> +6 diopters)
- •Non-normal best-corrected visual acuity (BCVA < 0.5 [20/40])
- •General health concerns or disorders, including heart and cardiovascular, neurological, nephrological, endocrinological, and psychiatric conditions
- •Ophthalmological or optometric conditions
- •Medication impacting visual, neuroendocrine, sleep, and circadian physiology
- •Drug and alcohol use (urinary drug screening & breathalyzer test)
- •Non-compliance with sleep-wake times: >1 deviation from ±60 minute window sleep and wake-up time
- •Non-compliance with caffeine intake (> 1 times caffeine intake)
- •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
结局指标
主要结局
Salivary melatonin
时间窗: Through study completion, estimated 1.5 years (within 3 weeks for each participant)
Salivary melatonin. Saliva samples (\>1 mL) will be taken from the participants every 30 Minutes using Salivettes. The Salivettes will be centrifuged, the cotton part removed and immediately frozen at -20°C. At a later point, melatonin \[in pg\] will be determined in these samples by double-antibody radioimmunoassay (RIA). To quantify melatonin suppression, the analytic team will calculate the area under the curve (AUC) for each laboratory condition.
次要结局
- Sleep Onset Latency (PSG-derived)(Through study completion, estimated 1.5 years (within 3 weeks for each participant))
- Subjective sleepiness(Through study completion, estimated 1.5 years (within 3 weeks for each participant))
- Sleep stages (PSG-derived)(Through study completion, estimated 1.5 years (within 3 weeks for each participant))
- Melanopsin sensitivity (pupillary light response)(Through study completion, estimated 1.5 years (within 3 weeks for each participant))
- Slow wave activity (PSG-derived)(Through study completion, estimated 1.5 years (within 3 weeks for each participant))
- Objective sleepiness 2(Through study completion, estimated 1.5 years (within 3 weeks for each participant))
- Vigilant attention(Through study completion, estimated 1.5 years (within 3 weeks for each participant))
- Skin temperature(Through study completion, estimated 1.5 years (within 3 weeks for each participant))
- Objective sleepiness 1(Through study completion, estimated 1.5 years (within 3 weeks for each participant))
研究者
Dr Christian Cajochen
Principal Investigator/ Sponsor-Investigator
University Psychiatric Clinics Basel