Pupillometry in DSWPD Type 1 and Type 2
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 220
- 试验地点
- 1
- 主要终点
- Melatonin suppression
研究概览
简要总结
The goal of this observational study is to characterize the pupil light response in patients with delayed sleep-wake phase disorder. A subset of participants will take part in a clinical trial to determine if increasing serotonin can alter the circadian response to light. The main questions it aims to answer is:
Are there differences in the light response in patients with delayed sleep-wake phase disorder? Does citalopram increase melatonin suppression in patients with delayed sleep-wake phase disorder?
Participants will complete activity and melatonin testing at home to determine their circadian timing. This will be followed by an eye test looking at the pupil response to different light stimuli. A subset of participants will complete two inpatient admissions where melatonin levels will be sampled and they will be exposed to a bright light. During one round of testing they will receive a placebo and in the other round of testing they will take a single dose of citalopram, a selective serotonin reuptake inhibitor.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Delayed sleep-wake phase disorder
排除标准
- •Use of medications known to alter pupil diameter
- •History of eye disease or eye surgery
- •Unstable medical or psychiatric condition
- •Shift work or self imposed irregular sleep schedules
- •Caffeine consumption >400mg/day
研究组 & 干预措施
DSWPD
Placebo or Citalopram followed by bright light (all participants will receive both interventions in random order).
干预措施: Light and Citalopram (Combination Product)
结局指标
主要结局
Melatonin suppression
时间窗: 8 hours
Saliva melatonin samples will be collected before and after light exposure
次要结局
未报告次要终点
研究者
Sabra Abbott
Professor
Northwestern University