SHIFT: Use of Consumer Sleep Technology to Treat Shift Work Disorder

Sponsor

Henry Ford Health System (Other)

Overall Status

Recruiting

CT.gov ID

NCT05186233

Collaborator

American Academy of Sleep Medicine (Other)

Enrollment

Location

Arms

33.5

Anticipated Duration (Months)

1.5

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Shift-work Disorder	Behavioral: Phototherapy	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

50 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Apr 18, 2022

Anticipated Primary Completion Date :

Jan 31, 2025

Anticipated Study Completion Date :

Jan 31, 2025

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Henry Ford Columbus Medical Center	Novi	Michigan	United States	48377

Sponsors and Collaborators

Henry Ford Health System
American Academy of Sleep Medicine

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Philip Cheng, Assistant Scientist, Henry Ford Health System

ClinicalTrials.gov Identifier:

NCT05186233

Other Study ID Numbers:

15108

First Posted:

Jan 11, 2022

Last Update Posted:

Jun 24, 2022

Last Verified:

Jun 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Additional relevant MeSH terms:

Disease

Study Results

No Results Posted as of Jun 24, 2022