Understanding Circadian Responses to Light in Persons With Mild Cognitive Impairment and Alzheimer's Disease
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 36
- 试验地点
- 2
- 主要终点
- Melatonin Levels
研究概览
简要总结
The purpose of this research study is to investigate the relationship between light, the thickness of the pigment at the back of your eye, melatonin levels, and memory. The study will investigate whether changing light distribution pattern from "on-axis"' (i.e., directed along the eye's visual axis to the fovea) to "off-axis" (i.e., directed on the periphery of the eye's visual axis) impact melatonin suppression in 24 mild cognitive impairment participants and 24 healthy, age-matched controls.
详细描述
Eligible enrolled subjects will be exposed to 4 different lighting conditions in addition to one dark control condition. There will be 5 study session and each one will last for 90 minutes and will be separated by one week. Subjects will collect 3 saliva samples, each one 30 minutes apart for melatonin levels during each study session.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None (Participant)
入排标准
- 年龄范围
- 55 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •mild cognitive impairment
- •age matched healthy control
- •macular pigment density either < 0.3 or > 0.5
排除标准
- •extensive brain vascular disease
- •Parkinson's disease
- •bipolar disorder
- •seasonal depression
- •high blood pressure
- •obstructing cataracts
- •macular degeneration
- •diabetic retinopathy
- •use of melatonin supplements
- •use of beta blockers
- •use of sleep medications
- •use of antidepressant medication
结局指标
主要结局
Melatonin Levels
时间窗: post-intervention (60 minutes) on each night of intervention (one night a week for 5 weeks)
Saliva samples collected for melatonin levels for the different conditions. Blue light (λmax = 451 nm) on axis and off axis: for each narrowband source, designated on-axis or off-axis, will have distinct lighting distribution patterns but calibrated to deliver the same targeted levels of circadian light (CLA) and circadian stimulus (CS) at the eye. Green light (λmax = 522 nm) on and off axis: for each narrowband source, designated on-axis or off-axis, will have distinct lighting distribution patterns but calibrated to deliver the same targeted levels of circadian light (CLA) and circadian stimulus (CS) at the eye. Dim-light control condition: (\< 5 lux at the eye) for 30 min
次要结局
未报告次要终点
研究者
Mariana Figueiro
Professor
Icahn School of Medicine at Mount Sinai