NCT06809335 · Henry Ford Health System
A Pilot of a Personalized Circadian mHealth to Improve Sleep in Night Shift Workers
(SAIL)
What this study is about
The goal of this project is to establish the evidence base for equitable accessibility and implementation of the precision sleep medicine mobile application, SHIFT.
View original scientific description
The goal of this project is to establish the evidence base for equitable accessibility and implementation of the precision sleep medicine mobile application, SHIFT.
Interventions
OTHER
Personalized circadian mHealth
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.
Primary outcome measures
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.
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
- Current use of medications that impact sleep-wake functioning
- Alcohol and substance use disorder
Where
- Novi, Michigan
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Mar 2, 2026 · Source of record for eligibility and locations