Sleep Reactivity as a Novel Mechanism in Shift Work Disorder
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 150
- 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 project is to test sleep reactivity as an independent cause of Shift Work Disorder (SWD). The primary hypothesis is that those with high sleep reactivity will show persistent SWD symptoms after experimental reduction of circadian misalignment, which will then be mitigated with CBT.
详细描述
The first aim of this study is to establish sleep reactivity as a predictor of insomnia in SWD independent from circadian misalignment. The second aim of this study is to establish sleep reactivity as a predictor of sleepiness in SWD independent from circadian misalignment. The third aim of this study is to probe sleep reactivity as a cause of insomnia in SWD. The fourth aim of this study is to probe sleep reactivity as a cause of sleepiness in SWD.
Participants with Shift Work Disorder (SWD, N=150) with high and low sleep reactivity will be enrolled. This study will use a two-step mechanistic randomized controlled trial design stratified by high and low sleep reactivity to examine the independent effect of sleep reactivity in SWD after experimental reduction of circadian misalignment. The first step will experimentally reduce circadian misalignment compared to a control. Those who achieve reduced circadian misalignment (melatonin onset at or later than 4am, i.e., compromised phase position) and remain symptomatic will continue to the second step where sleep reactivity will be probed with CBT compared to a sleep education control.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Other
- 盲法
- Double (Participant, Investigator)
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 be working a fixed nightshift schedule, operationalized as: a) working at least three night shifts a week, b) shifts must begin between 18:00 and 02:00, and last between 8 to 12 hours, and c) must also plan to maintain the nightshift schedule for the duration of the study
- •Participants must have Shift Work Disorder, which will be diagnosed based on ICSD-3 criteria
- •Participants must show circadian misalignment, operationalized as a baseline melatonin onset between 18:00 and 01:
- •Participants must be at least 18 years old
排除标准
- •Insomnia disorder or excessive sleepiness predating the onset of shift work
- •Termination of nightshift schedule
- •Presence of other sleep disorders (e.g. obstructive sleep apnea, narcolepsy) determined by standard clinical polysomnography
- •Diagnosis of bipolar disorder
- •History of neurological disorders determined by self-report and medical history
- •Pregnancy
- •Alcohol use disorder
- •Illicit drug use via self-report and urine drug screen if reasonable suspicion to test
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.
Sleep reactivity
时间窗: Within two weeks of treatment
Sleep reactivity will be measured using the validated Ford Insomnia Response to Stress Test (FIRST). Based on psychometric testing of the FIRST, a cutoff score of 16 will distinguish high and low sleep reactivity.
次要结局
- Insomnia(Within one week of post-treatment)
- Sleepiness(Within one week of post-treamtnet)
研究者
Philip Cheng
Associate Professor
Henry Ford Health System