RecruitingNot Applicable

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

United States300 participantsStarted 2023-10-23

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Establish the effect of SHIFT on stakeholder-centered outcomes.

Timeframe: From enrollment to the 8 month point.

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

Timeframe: From enrollment to the 8 month point.

Trial details

NCT IDNCT06809335

SponsorHenry Ford Health System

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-06

Contact for this trial

Philip Cheng, PhD

248-344-7361 pcheng1@hfhs.org

View on ClinicalTrials.gov More Shift Work Sleep Disorder trials

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.