Evaluation of Circadian OS Technology on Melatonin Suppression
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Melatonin Level
研究概览
简要总结
Primary Objective: Evaluate how the Circadian OS iPad-based light intervention suppresses melatonin. This small pilot study is designed to validate the Circadian OS technology by testing physiological response using melatonin suppression. The study aims to evaluate how the Circadian OS iPad-based light intervention influences sleepiness as measured objectively via suppression of melatonin and subjectively via the Karolinska Sleepiness scale.
详细描述
Aims: To test whether the Circadian OS app delivers sufficient circadian effective light that will result in measurable melatonin suppression (target suppression is 30% after 1 hour exposure)
Hypothesis
The Circadian OS app will deliver a Circadian Stimulus (CS) of 0.3 at the eye level and will result in 30% melatonin suppression after one hour using the device compared to less than 10% suppression without the Circadian OS app and the subjects will feel less sleepy (KSS score) when exposed to the Circadian OS app compared to no app
Outcomes: melatonin suppression will be calculated from saliva samples and subjective sleepiness as self-rated on the Karolinska Sleepiness Scale (KSS)
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 30 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy adults over the age of 30
排除标准
- •Use of over-the-counter melatonin or prescription medications
- •Obstructing cataracts, macular degeneration, or blindness
- •Heart disease or high blood pressure
结局指标
主要结局
Melatonin Level
时间窗: immediately prior to the iPad turning on, after 30 minutes of light exposure and after 60 minutes of light exposure
Melatonin is a natural hormone that is mainly produced by a gland in the brain and helps regulate the body's natural sleep-wake cycle.
次要结局
- Karolinska Sleepiness Scale (KSS)(immediately prior to the iPad turning on, after 30 minutes of light exposure and after 60 minutes of light exposure)
研究者
Mariana Figueiro
Director, Light and Health Research Center at Mount Sinai
Icahn School of Medicine at Mount Sinai