Impact of Sex and Age on Non-visual Light Input That Affects Sleep and Circadian Rhythms
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- Melatonin levels for circadian timing assessment
研究概览
简要总结
The goal of this clinical trial is to learn how the pupil responds to different light stimuli and how that relates to sleep and daily rhythms in healthy people of different ages.
The main questions it aims to answer are:
- Does the eye's pupil response to light stimuli differ by the sex and age of the participant?
- Is the eye's pupil response to light stimuli related to each participant's sleep timing, their body clock timing, and their hormone responses to light.
Participants will have a special eye exam and complete questionnaires before starting the study to see if they can participate. If they can participate, they will wear a special watch that monitors their activity and light levels for one week. Then they will live in a research room at the Mass General Hospital for 3 days/2 nights during which we will test their pupil response to light, their body clock timing, and their hormone responses to light.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •(i) 18-85 years old.
- •(ii) Habitual sleep onset 10 pm- 1 am (healthy controls only);
- •(iii) Habitual wake onset 5:30 am- 8:30 am (healthy controls only);
- •(iv) vision correctable to 20/30;
- •(v) stable medically.
- •(vi) ability to speak, understand, and read English at a high school level
排除标准
- •(i) Color blind by Ishihara Color Blindness Test;
- •(ii) any history of eye trauma, surgery or abnormality (e.g., retinopathy, glaucoma, cataracts, amblyopia, macular degeneration, congenital color vision deficiencies, or any type of blindness) besides correctable vision abnormalities (e.g., with glasses); any abnormalities on clinical eye exam (e.g., neuritis, Neuromyelitis optica, treated or untreated glaucoma) such that the ophthalmologist recommends the participant not be studied; Limited cataracts (e.g., Lens Opacities Classification (LOCS) III grade <2) will be allowed and documented during the eye exam. Eye drops that affect pupil size or contractility (e.g. mydriatics, miotics); drops to treat glaucoma (e.g., pilocarpine, brimonidine, other drops like artificial tear drops, or anti-inflammatory drops would not be exclusionary)
- •(iii) current or history of neurologic or psychiatric disease including autonomic function disorder or migraines; psychiatric disorder requiring medications in a first degree relative (healthy controls only); limited-duration counseling without prescription medications will not be exclusionary; (iv) current or history of circadian rhythm sleep-wake disorder (healthy controls only);
- •(v) prescription or non-prescription drugs affecting the pupil (e.g., affecting autonomic function), sleep, melatonin (e.g., lithium, alpha- and beta-adrenergic antagonists), and/or circadian rhythms (e.g., beta blockers, non-steroidal anti-inflammatory drugs, tricyclics);
- •(vi) Other disorders that can affect or may be affected by intrinsically photosensitive Retinal Ganglion Cell (ipRGC) function, including diabetes mellitus, multiple sclerosis, Parkinson's disease, seasonal affective disorder;
- •(vii) shift- or night-work in past three months; history of night work in preceding 3 year period
- •(viii) crossing more than 2 time zones in past three months;
- •(ix) presence of depression as assessed by a Beck Depression Inventory (BDI) score >
- •(x) pregnant or less than 6 weeks post-partum or breast-feeding
研究组 & 干预措施
Testing non-visual light impacts on pupil response, circadian timing, and hormones
- Pupillometry on day 1 in afternoon and evening and on day 2 in morning and evening. Participants will be randomized to one of 8 different light stimuli within the pupillometry
- Red light exposure on night 1 to determine circadian timing
- Blue/green light exposure on night 2 to compare hormone response during blue/green light to that during red light on night 1
干预措施: Pupillometry (Device)
Testing non-visual light impacts on pupil response, circadian timing, and hormones
- Pupillometry on day 1 in afternoon and evening and on day 2 in morning and evening. Participants will be randomized to one of 8 different light stimuli within the pupillometry
- Red light exposure on night 1 to determine circadian timing
- Blue/green light exposure on night 2 to compare hormone response during blue/green light to that during red light on night 1
干预措施: Light box exposure (Device)
结局指标
主要结局
Melatonin levels for circadian timing assessment
时间窗: Night 1
Melatonin levels from saliva collection during Night 1 light box red light exposure
Melatonin levels for hormone response
时间窗: Night 1 and Night 2
Melatonin levels from saliva collection during Night 2 light box blue/green light exposure compared to those during Night 1 light box red light exposure
Pupil size
时间窗: During pupillometry testing on Day 1 afternoon, Day 1 evening, Day 2 morning, Day 2 evening
Pupil size as measured by pupillometry
次要结局
未报告次要终点
研究者
Elizabeth B Klerman MD PhD
Professor
Massachusetts General Hospital