Innovations in Wearable Technology for Correcting Circadian Misalignment in Shift Work Disorder
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 63
- 试验地点
- 2
- 主要终点
- Dim light melatonin onset
研究概览
简要总结
The purpose of this study is to examine the effectiveness of a personalized light exposure schedule for Shift Work Disorder (SWD) in night shift workers compared to a non-personalized light exposure schedule.
详细描述
Participants will be randomized into each condition (n = 25) in a 1:1 ratio. Variables of interest, dim light melatonin onset (DLMO) and shift work disorder (SWD) symptoms, will be assessed before and after the intervention, which will last two weeks. All participants (N=50) will be asked to wear an Apple Watch for two weeks leading up to an in-lab visit. Activity data collection from the Apple Watch will be processed through a mathematical model of the human circadian pacemaker (previously validated in SWD) to generate estimates of DLMO. This two-week period is followed by a 27-hour laboratory visit for pre-treatment assessment of DLMO (hourly saliva melatonin samples over 24 hours). At the end of this visit, participants will receive an orientation to the SHIFT mobile application, where they will be able to assess their prescribed light exposure schedule.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- 否
入选标准
- •Participants must work at least 2 night shifts a week
- •Participants must have night shifts starting between 18:00 and 02:00 and lasting 8 to 12 hours
- •Participants must have maintained this night shift schedule for at least 6 months
- •Participants must have Shift Work Disorder, diagnosed based on ICSD-3 criteria
排除标准
- •Medical history of central nervous system disorders
- •Medical history of other sleep disorders
- •Diagnosis of an unstable major medical condition medical chart review
- •Dependence on alcohol (≥ 4 beverages a day)
- •Heavy tobacco use (≥ 10 cigarettes per day)
- •Recreational drug use
- •Use of medications impacting central nervous system functioning
- •Caffeine use in excess of 5-6 servings (~ 600mg) per day
- •Pregnancy
结局指标
主要结局
Dim light melatonin onset
时间窗: Within two days of treatment for a duration of 24 hours
Melatonin values will be measured in saliva samples, collected in dim light conditions in a laboratory, to determine circadian phase.
次要结局
- Daytime sleepiness(Within one week of post-treatment)
- Insomnia(Within one week of post-treatment)
研究者
Philip Cheng
Assistant Scientist
Henry Ford Health System