A Pilot of a Personalized Circadian MHealth to Improve Sleep in Night Shift Workers
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Establish the effect of SHIFT on stakeholder-centered outcomes.
研究概览
简要总结
The goal of this project is to establish the evidence base for equitable accessibility and implementation of the precision sleep medicine mobile application, SHIFT.
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
- 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
- •Inadequate sleep duration (habitual sleep less than 7 hours during the day)
- •Willingness to download the SHIFT app and follow the lighting recommendations
- •Ability to follow a set sleep schedule of 7 hours in bed after the night shifts
- •Working at least 4 night shifts a month
- •Shifts that must begin between 18:00 and 02:00 and last 8 to 12 hours
- •Score of 8 or above on the Epworth Sleepiness scale and/or a score of 8 or above on the Insomnia Severity Index
排除标准
- •Other independent sleep disorders (e.g., obstructive sleep apnea, narcolepsy, etc.)
- •History of seizures or other significant neurological disorders
- •Bipolar disorder
- •Termination of shift schedule
- •Pregnancy
- •Current use of medications that impact sleep-wake functioning
- •Alcohol and substance use disorder
研究组 & 干预措施
SHIFT App
Participants in this condition will receive an access code to download the mobile application and conduct an orientation to SHIFT and the study procedures with a study team member. They will then enter four weeks of study directed use of SHIFT where they are trained on a daily procedure of opening SHIFT at the beginning of their day and planning their day in accordance with the app recommendations. App usage (4 times per week) will be incentivized with weekly bonuses added to study compensation. Following the four weeks of study-directed use, participants will continue with self-directed use. At four months, participants will then complete a booster session with two additional weeks of study-directed use, followed by self-directed use until the end of the study. The structure with the booster session has evidence for maintaining treatment gains and is also in alignment with the commercialization plan.
干预措施: Personalized circadian mHealth (Other)
Waitlist Control
Participants in this condition will only complete questionnaires for the initial eight months. Those who remain shift workers will have the option of receiving the SHIFT app and the option to complete follow-up surveys in the same manner as the SHIFT App condition.
结局指标
主要结局
Establish the effect of SHIFT on stakeholder-centered outcomes.
时间窗: From enrollment to the 8 month point.
Aim 1a. Measure the effect of SHIFT on work productivity and satisfaction compared to waitlist control using the Job Satisfaction Index. Effect will be tested using a mixed-effects linear regression model with participants as the random effect and Time, Condition, and the Time × Condition interaction term as the fixed effects. Aim 1b: Measure the effect of SHIFT on global health compared to waitlist control using the NIH PROMIS Global Health questionnaire. Effect will be tested using the same method as Aim 1a. Aim 1c. Measure the effect of SHIFT on turnover compared to waitlist control, measured at 8-month follow-up. Turnover will be operationalized as an individual who has either terminated the position they were in at baseline or is no longer engaged in shift work as operationalized in the study. Effect will be determined using a generalized mixed-effects regression with turnover as a dichotomous outcome.
Compare use experience and accuracy of SLEEP Android to the original iOS version.
时间窗: From enrollment to the 8 month point.
Aim 2a. Measure user experience of Android and iOS versions of SHIFT using the User Experience Questionnaire (UEQ). The following ranges of clinical indifference will be used: ± 3 points on the User Experience Questionnaire based on the bin size of 6 for each of the thresholds (bad, neutral, and good user experience). Aim 2b. Measure accuracy of predicted circadian misalignment (CM), sleep, and depression in Android and iOS versions. CM will be indexed with the outputs of the biomathematical model of the circadian system. Sleep will be measured using the Insomnia Severity Index and sleep diaries. Depression will be measured using the Quick Inventory of Depressive Symptomatology. The following ranges of clinical indifference will be used: 1) predicted CM = ± 3 hours based on approximately 2x the absolute mean error of our model predictions, 2) insomnia severity = ± 6 points, and 3) depression = 28.5% of the QIDS-SR16 score.
次要结局
- Assess facilitators and barriers to engagement and implementation.(Immediately following completion of 8-month treatment period.)
研究者
Philip Cheng
Associate Scientist
Henry Ford Health System