Recruiting

Circadian MHealth

Sponsor:

Henry Ford Health System

Code:

NCT06809335

Conditions

Shift Work Sleep Disorder

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Personalized circadian mHealth

Study Details

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

Study ID

NCT06809335

Start date

Oct 23, 2023

Status verified date

Feb, 2026

Completion date

Jun, 2027

Anticipated

Primary completion date

Jun, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

300 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: SHIFT App

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.

no intervention: Waitlist Control

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

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 measure

  • Establish the effect of SHIFT on stakeholder-centered outcomes. [ Time Frame: From enrollment to the 8 month point. ]
  • Compare use experience and accuracy of SLEEP Android to the original iOS version. [ Time Frame: From enrollment to the 8 month point. ]

Central Contacts and Locations

Central contacts

Locations

Henry Ford Columbus Medical Center

Recruiting

Novi, Michigan, United States, 48377

Contacts

More Information

Sponsor

Henry Ford Health System

Last update posted

Mar 2, 2026

Last verified

Feb, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Henry Ford Health System on 2026-03-02.