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NCT Number: NCT06809335

A Pilot of a Personalized Circadian mHealth to Improve Sleep in Night Shift Workers

The goal of this project is to establish the evidence base for equitable accessibility and implementation of the precision sleep medicine mobile application, SHIFT.

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Key information

Conditions

Shift Work Sleep Disorder Chronobiology Disorders Dyssomnias Mental Disorders Nervous System Diseases Occupational Diseases Sleep Disorders, Circadian Rhythm Sleep Wake Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Personalized circadian mHealth

Other

SHIFT is a mobile application designed to improve sleep in night shift workers. The SHIFT mobile application is used to collect data from an Apple Watch to assess an individual shift worker's body-clock timing and make personalized recommendations of light exposure schedules that are designed to align the body-clock with the night shift work schedule.

Other names: SHIFT

Primary outcomes

  1. Establish the effect of SHIFT on stakeholder-centered outcomes.

    Time frame: 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.

  2. Compare use experience and accuracy of SLEEP Android to the original iOS version.

    Time frame: 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.

Secondary outcomes

  1. Assess facilitators and barriers to engagement and implementation.

    Time frame: Immediately following completion of 8-month treatment period.

    A series of semi-structured interviews will be used for thematic analysis, and a comprehensive roadmap for future app updates based on user feedback. The semi-structured interviews will utilize the interview-guide approach following the CFIR framework selected for this study. Six phases will be followed for thematic analysis: (1) data familiarization, (2) generating initial codes, (3) searching for themes, (4) reviewing themes, (5) defining and naming themes, and (6) producing the report. We will combine deductive and inductive techniques to increase the accuracy of thematic analyses.

Study contacts

Contact information is provided by the study sponsor or research team.

Marleigh Treger, BS

CONTACT

[email protected]

248-344-8028

Philip Cheng, PhD

CONTACT

[email protected]

248-344-7361

Sponsors and collaborators

Lead sponsor

Henry Ford Health System

Other

Registry information

Acronym: SAIL

Important dates

Study start
2023
Primary completion
2027
Study completion
2027
First posted
Feb 5, 2025
Registry last updated
Mar 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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