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

NCT06809335 | Recruiting

• 1 other identifier: 16061
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Shift Work Sleep Disorder

Outcome Measures

Primary Outcomes (2)

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

  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.

  From enrollment to the 8 month point.

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

  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.

  From enrollment to the 8 month point.

Secondary Outcomes (1)

• Assess facilitators and barriers to engagement and implementation.

  Immediately following completion of 8-month treatment period.

Study Arms (2)

SHIFT App

EXPERIMENTAL

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.

Other: Personalized circadian mHealth

Waitlist Control

NO INTERVENTION

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.

Interventions

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.

Also known as: SHIFT

SHIFT App

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Henry Ford Health System: lead

Study Sites (1)

Henry Ford Columbus Medical Center

Novi, Michigan, 48377, United States

RECRUITING

MeSH Terms

Conditions

Sleep Disorders, Circadian Rhythm

Condition Hierarchy (Ancestors)

Chronobiology Disorders; Nervous System Diseases; Dyssomnias; Sleep Wake Disorders; Occupational Diseases; Mental Disorders

Central Study Contacts

Philip Cheng, PhD

CONTACT

248-344-7361; pcheng1@hfhs.org

Marleigh Treger, BS

CONTACT

248-344-8028; mtreger1@hfhs.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Scientist

Study Record Dates

• First Submitted: January 23, 2025
• First Posted: February 5, 2025
• Study Start: October 23, 2023
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): June 1, 2027
• Last Updated: March 2, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)