A Pilot of a Personalized Circadian MHealth to Improve Sleep in Night Shift Workers (SAIL)

Henry Ford Health

Status: Enrolling

Conditions: Shift Work Sleep Disorder

Treatments: Other: Personalized circadian mHealth

Study type: Interventional

Funder types: Other

Identifiers

NCT06809335

16061

Details and patient eligibility

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.

Enrollment: 300 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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300 participants in 2 patient groups

SHIFT App

Experimental group

Description:

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.

Treatment:

Other: Personalized circadian mHealth

Waitlist Control

No Intervention group

Description:

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.