Filtered Eyewear to Prevent Light-induced Melatonin Suppression While Maintaining Visual Performance and Alertness in Night-shift Working Nurses - Aim 1
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 29
- 试验地点
- 2
- 主要终点
- Melatonin Levels AUC
研究概览
简要总结
The aim of this study is to determine the relative effectiveness of monocular and binocular light exposures, with and without selective blue-blocking filtering, on nocturnal melatonin suppression, subjective sleepiness, and visual performance of night shift workers.
详细描述
Over the course of six, 5-hour study nights, 30 participants will be randomized to 6 study conditions, 1) binocular dim-light control unfiltered, (2) monocular dim-light control (one eye occluded), (3) unfiltered binocular, (4) unfiltered monocular (non-dominant eye occluded), (5) filtered binocular (both eyes filtered), (6) filtered monocular (non-dominant eye filtered, the other non-filtered). Saliva samples will be collected every 30 minutes for melatonin levels. Participants will also be asked to provide subjective sleepiness and visual performance will be assessed. Study nights will be separated by one week and each participant will be randomized to one of the six study conditions each night. All participants will see all conditions.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- •Bipolar disorder
- •Seasonal depression
- •High blood pressure
- •History of cancer
- •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 AUC
时间窗: Each night for 6 study nights
Melatonin levels to assess Melatonin Suppression. Saliva samples will be collected every 30 minutes for melatonin levels.
Melatonin Levels AUC
时间窗: Each night for 6 study nights
Melatonin levels to assess Melatonin Suppression. Saliva samples will be collected every 30 minutes for melatonin levels.
次要结局
- Karolinska Sleepiness scale to measure Subjective Sleepiness(Each night for 6 study nights)
- Numerical Verification Task (NVT)(Each night for 6 study nights)
研究者
Mariana Figueiro
Professor
Icahn School of Medicine at Mount Sinai