Recruiting NCT06809335
A Pilot of a Personalized Circadian mHealth to Improve Sleep in Night Shift Workers
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Personalized circadian mHealth.
- Who it may be relevant to
- Registry conditions: Shift Work Sleep Disorder. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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.]
- Compare use experience and accuracy of SLEEP Android to the original iOS version. [Time frame: From enrollment to the 8 month point.]
Secondary outcome measures (1)
- Assess facilitators and barriers to engagement and implementation. [Time frame: Immediately following completion of 8-month treatment period.]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
United States · 1 center
- Henry Ford Columbus Medical Center — Novi
Identifiers
NCT: NCT06809335 · 16061