A Pilot of a Personalized Circadian MHealth to Improve Sleep in Night Shift Workers
NCT ID: NCT06809335
Last Updated: 2025-02-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
300 participants
INTERVENTIONAL
2023-10-23
2027-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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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.
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.
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.
No interventions assigned to this group
Interventions
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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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Henry Ford Health System
OTHER
Responsible Party
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Philip Cheng
Associate Scientist
Locations
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Henry Ford Columbus Medical Center
Novi, Michigan, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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16061
Identifier Type: -
Identifier Source: org_study_id
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