A Multi-Sensor Machine Learning Approach to Precision Sleep Tracking for Nightshift Workers
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Sleep Continuity- Time in Bed
研究概览
简要总结
Sleep is often a challenge for nightshift workers because their work and sleep schedules are inverted. Sleep is commonly measured using actigraphy, which is the standard measure of objective sleep in the general population; however, this method has substantial limitations for nightshift workers because the standard legacy algorithms only correctly identify 50.3% of daytime sleep. This significantly reduces the validity for nightshift workers. The purpose of this study is to test a novel method to expand actigraphy by using 1) a multi-sensor approach that 2) uses machine learning (ML) algorithms to increase the accuracy of detecting daytime sleep.
详细描述
The first aim of this study is to establish an open-source machine learning algorithm for sleep tracking that outperforms legacy actigraphy algorithms in detecting daytime sleep periods. The second aim is to enhance tracking of sleep continuity variables by adding multiple sensors. The final aim is to identify facilitators and barriers of at-home implementation of multi-sensor sleep tracking. Our central hypothesis is that a multi-sensor ML approach will outperform legacy algorithms against gold-standard polysomnography (PSG).
This study will be type I hybrid effectiveness-implementation trial that 1) validates the proposed multi-sensor ML approach using in-lab polysomnography, and 2) examines implementation of the multi-sensor ML approach in an ecologically valid setting via an at-home implementation for four weeks. A sample of nightshift workers will be enrolled in the in-lab validation portion of the study and will be hooked-up to PSG with continuous data collection for the duration of the lab visit to capture five planned sleep opportunities at varying lengths (4 hr, 2 hr, 1.5 hr, and two 30-minute naps; 8 hrs total). For each participant, sensor data will be processed using two separate methods. For the legacy actigraphy algorithm method, only raw accelerometer data will be processed. For the multi-sensor machine learning method, accelerometer data from the watch along with additional sensors will be processed using a machine learning algorithm. Some participants who complete the in-lab portion of the study will be asked to complete the at-home portion of the study, which includes 4 weeks of at-home sleep tracking using the multi-sensor approach. Participants will receive the sensor kit and will have an at-home appointment with study staff to aid with sensor set-up, which will then be collected again at the end of the 4-week period. Daily sleep diaries will also be collected during the 4 weeks to enable data quality check.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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
- 是
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 worked the nightshift for at least six months
- •Must plan to maintain the nightshift schedule for the duration of the study
- •Participants must be at least 18 years old
排除标准
- •Termination of nightshift schedule or planned travel during the study period
- •Does not have at least an average of 8-hour time bed opportunity per 24-hour period
- •Unwilling to integrate the study smart sensors in their bedroom environment
- •Illicit drug use via self-report and urine drug screen
- •History of neurological disorders
- •Alcohol use disorder
- •Pregnancy
研究组 & 干预措施
Single vs Multi-Sensor Sleep Tracking In-Lab
In Part 1 of the study, all participants' data will undergo two separate methods for analyzing sleep.
The legacy actigraphy algorithm methods will use only raw accelerometer data from a single sensor collected and processed using legacy actigraphy algorithms. The legacy algorithm is comprised first of reducing accelerometer data into activity counts per epoch, which will then be categorized into sleep or wake in accordance with the Cole-Kripke algorithm.
The multi-sensor machine learning (ML) method will use raw accelerometer data in addition to data from additional sensors from the watch, phone, and other smart sensors in the sleeping environment. These data will be processed using a machine learning algorithm.
干预措施: Single-Sensor Tracking (In-Lab) (Other)
Single vs Multi-Sensor Sleep Tracking In-Lab
In Part 1 of the study, all participants' data will undergo two separate methods for analyzing sleep.
The legacy actigraphy algorithm methods will use only raw accelerometer data from a single sensor collected and processed using legacy actigraphy algorithms. The legacy algorithm is comprised first of reducing accelerometer data into activity counts per epoch, which will then be categorized into sleep or wake in accordance with the Cole-Kripke algorithm.
The multi-sensor machine learning (ML) method will use raw accelerometer data in addition to data from additional sensors from the watch, phone, and other smart sensors in the sleeping environment. These data will be processed using a machine learning algorithm.
干预措施: Multi-Sensor Sleep Tracking (In-Lab) (Other)
Multi-Sensor Sleep Tracking At-Home
This condition includes 4 weeks of at-home sleep tracking using the multi-sensor approach. Daily sleep diaries will also be collected to enable data quality check. Once collected, all data will be processed with the same machine learning algorithm used in the in-lab experimental condition.
干预措施: Multi-Sensor Sleep Tracking (At-Home) (Other)
结局指标
主要结局
Sleep Continuity- Time in Bed
时间窗: Throughout study completion, up to 6 weeks
The amount of time (in minutes) a participant spends in bed from lights out to their final awakening time. All PSG variables will use standard American Academy of Sleep Medicine (AASM) sleep scoring rules. Data from the Apple Watch will have non-PSG inputs from the multi-sensor system to inform this sleep continuity variable.
Sleep Continuity- Sleep Onset Latency
时间窗: Throughout study completion, up to 6 weeks
The amount of time (in minutes) a participant takes to fall asleep, from the time of lights out, or the amount of time spent awake but attempting sleep from lights out. All PSG variables will use standard AASM sleep scoring rules; indicated with "lights out" marker on a PSG, EEG scored as wake, accompanied with a prototypical sleep posture (e.g. supine) with eyes closed. Data from the Apple Watch will have non-PSG inputs from the multi-sensor system to inform this sleep continuity variable including dim lights or darkness with lux near zero, presence in bed, rare/interspersed motion from phone and watch.
Sleep Continuity- Wake After Sleep Onset
时间窗: Throughout study completion, up to 6 weeks
The amount of time (in minutes) a participant spends awake from the time they initially falling asleep, and excluding their final wake up. All PSG variables will use standard AASM sleep scoring rules; indicated with "lights out" marker on a PSG, electroencephalography (EEG) scored as wake, accompanied with a prototypical sleep posture (e.g. supine) with eyes closed. Data from the Apple Watch will have non-PSG inputs from the multi-sensor system to inform this sleep continuity variable.
Sleep Continuity- Sleep Efficiency
时间窗: Throughout study completion, up to 6 weeks
The proportion of the total amount of time a participant is asleep of the total amount of time in bed \[(Total Sleep Time in minutes) / (Time in Bed in minutes)\]. All PSG variables will use standard AASM sleep scoring rules. Data from the Apple Watch will have non-PSG inputs from the multi-sensor system to inform this sleep continuity variable, including dim lights or darkness, presence in bed, prolonged low motion from phone and watch, breathing rate changes, and heart rate (sleep staging).
Wake
时间窗: Throughout study completion, up to 6 weeks
The amount of time (in minutes) a participant is awake \[or the absence of any type of sleep- Stage 1 (N1), Stage 2 (N2), Stage 3 (N3), Rapid Eye Movement (REM)\]. All PSG variables will use standard AASM sleep scoring rules; represented on PSG by activities prior to "lights out" marker or video monitoring (eg, video monitoring showing scrolling on social media in bed). Data from the Apple Watch will have non-PSG inputs from the multi-sensor system to inform these sleep continuity variables including motion, lights on, high heart rate.
Detection of Daytime Sleep Periods
时间窗: Throughout study completion, up to 6 weeks
Any sleep periods between 6a and 6p will be designated as daytime sleep. A daytime sleep period from the Apple Watch will be considered successfully detected if it falls within ±30 minutes of the PSG start and end times, and is at least 50% the length of the actual sleep period.
User experience
时间窗: Within two days of the at-home intervention
This will be indexed with the User Experience Questionnaire (UEQ) that has been validated for evaluation of new products and has clear and well-established benchmarks. The UEQ includes items along six domains: 1) Attractiveness (overall likability or appeal), 2) Perspicuity (learning curve and ease of use), 3) Efficiency (speed and efficiency of interactions), 4) Dependability (predictability of system behaviors), 5) Stimulation (how exciting and motivating the product is), 6) Novelty (innovation and creativity of the product).
次要结局
- Interviews(Within one month of the at-home intervention)
- Digital health technology literacy(During screening before the in-lab intervention)
研究者
Philip Cheng
Principal Investigator
Henry Ford Health System