Use of Consumer Sleep Technology to Treat Shift Work Disorder (SHIFT)

Innovations in Wearable Technology for Correcting Circadian Misalignment in Shift Work Disorder

The purpose of this study is to examine the effectiveness of a personalized light exposure schedule for Shift Work Disorder (SWD) in night shift workers compared to a non-personalized light exposure schedule.

Study Overview

• Status: Completed
• Conditions: Shift-work Disorder
• Intervention / Treatment: Behavioral: Phototherapy

Detailed Description

Participants will be randomized into each condition (n = 25) in a 1:1 ratio. Variables of interest, dim light melatonin onset (DLMO) and shift work disorder (SWD) symptoms, will be assessed before and after the intervention, which will last two weeks. All participants (N=50) will be asked to wear an Apple Watch for two weeks leading up to an in-lab visit. Activity data collection from the Apple Watch will be processed through a mathematical model of the human circadian pacemaker (previously validated in SWD) to generate estimates of DLMO. This two-week period is followed by a 27-hour laboratory visit for pre-treatment assessment of DLMO (hourly saliva melatonin samples over 24 hours). At the end of this visit, participants will receive an orientation to the SHIFT mobile application, where they will be able to assess their prescribed light exposure schedule.

• Study Type: Interventional
• Enrollment (Actual): 63
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Michigan
    • Novi, Michigan, United States, 48377
      • Henry Ford Columbus Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Participants must work at least 2 night shifts a week
• Participants must have night shifts starting between 18:00 and 02:00 and lasting 8 to 12 hours
• Participants must have maintained this night shift schedule for at least 6 months
• Participants must have Shift Work Disorder, diagnosed based on ICSD-3 criteria

Exclusion Criteria:

• Medical history of central nervous system disorders
• Medical history of other sleep disorders
• Diagnosis of an unstable major medical condition medical chart review
• Dependence on alcohol (≥ 4 beverages a day)
• Heavy tobacco use (≥ 10 cigarettes per day)
• Recreational drug use
• Use of medications impacting central nervous system functioning
• Caffeine use in excess of 5-6 servings (~ 600mg) per day
• Pregnancy

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Non-personalized light condition; Participants will receive light exposure recommendations from the SHIFT mobile application based on their habitual sleep schedule. Participants will follow these recommendations over the course of two weeks.	Behavioral: Phototherapy; Light exposure recommendations provided by SHIFT mobile application
Experimental: Personalized light condition; Participants will receive light exposure recommendations from the SHIFT mobile application based on their activity levels. Participants will follow these recommendations over the course of two weeks.	Behavioral: Phototherapy; Light exposure recommendations provided by SHIFT mobile application

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Dim light melatonin onset	Melatonin values will be measured in saliva samples, collected in dim light conditions in a laboratory, to determine circadian phase.	Within two days of treatment for a duration of 24 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Insomnia	Insomnia will be measured with the Insomnia Severity Scale (0 to 28; higher scores correspond to worse severity)	Within one week of post-treatment
Daytime sleepiness	Sleepiness will be measured with the Epworth Sleepiness Scale (0 to 24; a score of 10 or greater indicates excessive daytime sleepiness)	Within one week of post-treatment

Collaborators and Investigators

• Sponsor: Henry Ford Health System
• Collaborators: American Academy of Sleep Medicine

Study record dates

Study Major Dates

• Study Start (Actual): April 18, 2022
• Primary Completion (Actual): March 31, 2025
• Study Completion (Actual): March 31, 2025

Study Registration Dates

• First Submitted: December 15, 2021
• First Submitted That Met QC Criteria: January 6, 2022
• First Posted (Actual): January 11, 2022

Study Record Updates

• Last Update Posted (Actual): June 8, 2025
• Last Update Submitted That Met QC Criteria: June 4, 2025
• Last Verified: September 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Disease
• Other Study ID Numbers: 15108

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Request for data sharing will be evaluated on a case-by-case basis.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No