- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06670287
The Use of Multiple Sensors to Track Sleep in Nightshift Workers (SENSE)
A Multi-Sensor Machine Learning Approach to Precision Sleep Tracking for Nightshift Workers
Study Overview
Status
Conditions
Detailed Description
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.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Philip Cheng, PhD
- Phone Number: 248-344-7361
- Email: pcheng1@hfhs.org
Study Contact Backup
- Name: Elle M Wernette, PhD
- Phone Number: 2483442409
- Email: ewernet1@hfhs.org
Study Locations
-
-
Michigan
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Novi, Michigan, United States, 48377
- Recruiting
- Henry Ford Columbus Medical Center
-
Contact:
- Philip Cheng, PhD
- Phone Number: 248-344-7361
- Email: pcheng1@hfhs.org
-
Principal Investigator:
- Philip Cheng, PhD
-
Contact:
- Elle M Wernette, PhD
- Phone Number: 2483442409
- Email: ewernet1@hfhs.org
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Non-Randomized
- Interventional Model: Sequential Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: 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. |
In-lab sleep tracking using only raw accelerometer data from a single sensor collected and processed with legacy actigraphy algorithms.
In-lab sleep tracking using raw accelerometer data and additional sensors collected and processed with machine learning.
Other Names:
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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.
|
At-home sleep tracking using raw accelerometer data and additional sensors collected and processed with machine learning.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Sleep Continuity- Time in Bed
Time Frame: 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.
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Throughout study completion, up to 6 weeks
|
|
Sleep Continuity- Sleep Onset Latency
Time Frame: 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.
|
Throughout study completion, up to 6 weeks
|
|
Sleep Continuity- Wake After Sleep Onset
Time Frame: 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.
|
Throughout study completion, up to 6 weeks
|
|
Sleep Continuity- Sleep Efficiency
Time Frame: 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).
|
Throughout study completion, up to 6 weeks
|
|
Wake
Time Frame: 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.
|
Throughout study completion, up to 6 weeks
|
|
Detection of Daytime Sleep Periods
Time Frame: 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.
|
Throughout study completion, up to 6 weeks
|
|
User experience
Time Frame: 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).
|
Within two days of the at-home intervention
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Interviews
Time Frame: Within one month of the at-home intervention
|
These interviews will be semi-structured using the Consolidated Framework for Implementation Research (CFIR).
The moderator guide will solicit in-depth feedback on participants' experiences, challenges, and suggestions for improvement.
Key themes to be explored in the interviews include ease of use, comfort, perceived accuracy, and any barriers to regular use.
|
Within one month of the at-home intervention
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Digital health technology literacy
Time Frame: During screening before the in-lab intervention
|
This will be measured using the Digital Health Technology Literacy scale (DHTL).
This validated scale assesses degree of experience and skills in using digital health technology and services.
The DHTL has strong internal consistency (Cronbach's α = 0.95) and strong validity with completion of ten digital tasks such as connecting a device to Wi-Fi and Bluetooth, downloading and installing an app, and entering weight data into an app.
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During screening before the in-lab intervention
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Collaborators and Investigators
Sponsor
Collaborators
Publications and helpful links
General Publications
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- Hsieh HF, Shannon SE. Three approaches to qualitative content analysis. Qual Health Res. 2005 Nov;15(9):1277-88. doi: 10.1177/1049732305276687.
- Sadeh A, Sharkey KM, Carskadon MA. Activity-based sleep-wake identification: an empirical test of methodological issues. Sleep. 1994 Apr;17(3):201-7. doi: 10.1093/sleep/17.3.201.
- Cole RJ, Kripke DF, Gruen W, Mullaney DJ, Gillin JC. Automatic sleep/wake identification from wrist activity. Sleep. 1992 Oct;15(5):461-9. doi: 10.1093/sleep/15.5.461.
- Lichstein KL, Stone KC, Donaldson J, Nau SD, Soeffing JP, Murray D, Lester KW, Aguillard RN. Actigraphy validation with insomnia. Sleep. 2006 Feb;29(2):232-9.
- Van Dongen HP, Maislin G, Mullington JM, Dinges DF. The cumulative cost of additional wakefulness: dose-response effects on neurobehavioral functions and sleep physiology from chronic sleep restriction and total sleep deprivation. Sleep. 2003 Mar 15;26(2):117-26. doi: 10.1093/sleep/26.2.117. Erratum In: Sleep. 2004 Jun 15;27(4):600.
- Drake C, Richardson G, Roehrs T, Scofield H, Roth T. Vulnerability to stress-related sleep disturbance and hyperarousal. Sleep. 2004 Mar 15;27(2):285-91. doi: 10.1093/sleep/27.2.285.
- Drake C, Nickel C, Burduvali E, Roth T, Jefferson C, Pietro B. The pediatric daytime sleepiness scale (PDSS): sleep habits and school outcomes in middle-school children. Sleep. 2003 Jun 15;26(4):455-8.
- Walch O, Huang Y, Forger D, Goldstein C. Sleep stage prediction with raw acceleration and photoplethysmography heart rate data derived from a consumer wearable device. Sleep. 2019 Dec 24;42(12):zsz180. doi: 10.1093/sleep/zsz180.
- Karlsson B, Knutsson A, Lindahl B. Is there an association between shift work and having a metabolic syndrome? Results from a population based study of 27,485 people. Occup Environ Med. 2001 Nov;58(11):747-52. doi: 10.1136/oem.58.11.747.
- Drake CL, Roehrs T, Richardson G, Walsh JK, Roth T. Shift work sleep disorder: prevalence and consequences beyond that of symptomatic day workers. Sleep. 2004 Dec 15;27(8):1453-62. doi: 10.1093/sleep/27.8.1453.
- McHill AW, Melanson EL, Higgins J, Connick E, Moehlman TM, Stothard ER, Wright KP Jr. Impact of circadian misalignment on energy metabolism during simulated nightshift work. Proc Natl Acad Sci U S A. 2014 Dec 2;111(48):17302-7. doi: 10.1073/pnas.1412021111. Epub 2014 Nov 17.
- te Lindert BH, Van Someren EJ. Sleep estimates using microelectromechanical systems (MEMS). Sleep. 2013 May 1;36(5):781-9. doi: 10.5665/sleep.2648.
- Tobaldini E, Fiorelli EM, Solbiati M, Costantino G, Nobili L, Montano N. Short sleep duration and cardiometabolic risk: from pathophysiology to clinical evidence. Nat Rev Cardiol. 2019 Apr;16(4):213-224. doi: 10.1038/s41569-018-0109-6.
- Hysing M, Pallesen S, Stormark KM, Jakobsen R, Lundervold AJ, Sivertsen B. Sleep and use of electronic devices in adolescence: results from a large population-based study. BMJ Open. 2015 Feb 2;5(1):e006748. doi: 10.1136/bmjopen-2014-006748.
- Tricas-Vidal HJ, Lucha-Lopez MO, Hidalgo-Garcia C, Vidal-Peracho MC, Monti-Ballano S, Tricas-Moreno JM. Health Habits and Wearable Activity Tracker Devices: Analytical Cross-Sectional Study. Sensors (Basel). 2022 Apr 12;22(8):2960. doi: 10.3390/s22082960.
- Cheng P, Walch O, Huang Y, Mayer C, Sagong C, Cuamatzi Castelan A, Burgess HJ, Roth T, Forger DB, Drake CL. Predicting circadian misalignment with wearable technology: validation of wrist-worn actigraphy and photometry in night shift workers. Sleep. 2021 Feb 12;44(2):zsaa180. doi: 10.1093/sleep/zsaa180.
- Huang Y, Mayer C, Cheng P, Siddula A, Burgess HJ, Drake C, Goldstein C, Walch O, Forger DB. Predicting circadian phase across populations: a comparison of mathematical models and wearable devices. Sleep. 2021 Oct 11;44(10):zsab126. doi: 10.1093/sleep/zsab126.
- Lieberman HR, Agarwal S, Caldwell JA, Fulgoni VL. Demographics, sleep, and daily patterns of caffeine intake of shift workers in a nationally representative sample of the US adult population. Sleep. 2020 Mar 12;43(3):zsz240. doi: 10.1093/sleep/zsz240.
- Yoon J, Lee M, Ahn JS, Oh D, Shin SY, Chang YJ, Cho J. Development and Validation of Digital Health Technology Literacy Assessment Questionnaire. J Med Syst. 2022 Jan 24;46(2):13. doi: 10.1007/s10916-022-01800-8.
- Patterson MR, Nunes AAS, Gerstel D, Pilkar R, Guthrie T, Neishabouri A, Guo CC. 40 years of actigraphy in sleep medicine and current state of the art algorithms. NPJ Digit Med. 2023 Mar 24;6(1):51. doi: 10.1038/s41746-023-00802-1.
- Hjetland GJ, Skogen JC, Hysing M, Sivertsen B. The Association Between Self-Reported Screen Time, Social Media Addiction, and Sleep Among Norwegian University Students. Front Public Health. 2021 Dec 16;9:794307. doi: 10.3389/fpubh.2021.794307. eCollection 2021.
- Erickson ML, Wang W, Counts J, Redman LM, Parker D, Huebner JL, Dunn J, Kraus WE. Field-Based Assessments of Behavioral Patterns During Shiftwork in Police Academy Trainees Using Wearable Technology. J Biol Rhythms. 2022 Jun;37(3):260-271. doi: 10.1177/07487304221087068. Epub 2022 Apr 13.
- Baron KG, Abbott S, Jao N, Manalo N, Mullen R. Orthosomnia: Are Some Patients Taking the Quantified Self Too Far? J Clin Sleep Med. 2017 Feb 15;13(2):351-354. doi: 10.5664/jcsm.6472.
- Maric A, Burgi M, Werth E, Baumann CR, Poryazova R. Exploring the impact of experimental sleep restriction and sleep deprivation on subjectively perceived sleep parameters. J Sleep Res. 2019 Jun;28(3):e12706. doi: 10.1111/jsr.12706. Epub 2018 Jun 5.
- Fernandez-Mendoza J. The insomnia with short sleep duration phenotype: an update on it's importance for health and prevention. Curr Opin Psychiatry. 2017 Jan;30(1):56-63. doi: 10.1097/YCO.0000000000000292.
- Zhang Y, Papantoniou K. Night shift work and its carcinogenicity. Lancet Oncol. 2019 Oct;20(10):e550. doi: 10.1016/S1470-2045(19)30578-9. Epub 2019 Sep 30. No abstract available.
- Straif K, Baan R, Grosse Y, Secretan B, El Ghissassi F, Bouvard V, Altieri A, Benbrahim-Tallaa L, Cogliano V; WHO International Agency For Research on Cancer Monograph Working Group. Carcinogenicity of shift-work, painting, and fire-fighting. Lancet Oncol. 2007 Dec;8(12):1065-6. doi: 10.1016/S1470-2045(07)70373-X. No abstract available.
- Scott AJ, Monk TH, Brink LL. Shiftwork as a Risk Factor for Depression: A Pilot Study. Int J Occup Environ Health. 1997 Jul;3(Supplement 2):S2-S9.
- Kalmbach DA, Pillai V, Cheng P, Arnedt JT, Drake CL. Shift work disorder, depression, and anxiety in the transition to rotating shifts: the role of sleep reactivity. Sleep Med. 2015 Dec;16(12):1532-8. doi: 10.1016/j.sleep.2015.09.007. Epub 2015 Sep 28.
- Puttonen S, Harma M, Hublin C. Shift work and cardiovascular disease - pathways from circadian stress to morbidity. Scand J Work Environ Health. 2010 Mar;36(2):96-108. doi: 10.5271/sjweh.2894. Epub 2010 Jan 20.
- Boggild H, Knutsson A. Shift work, risk factors and cardiovascular disease. Scand J Work Environ Health. 1999 Apr;25(2):85-99. doi: 10.5271/sjweh.410.
- Lee J, Yoo SK. Respiration Rate Estimation Based on Independent Component Analysis of Accelerometer Data: Pilot Single-Arm Intervention Study. JMIR Mhealth Uhealth. 2020 Aug 10;8(8):e17803. doi: 10.2196/17803.
- Brito RS, Dias C, Afonso Filho A, Salles C. Prevalence of insomnia in shift workers: a systematic review. Sleep Sci. 2021 Jan-Mar;14(1):47-54. doi: 10.5935/1984-0063.20190150.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 17505 (Other Identifier: City of Hope Medical Center)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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