Use of Consumer Sleep Technology to Treat Shift Work Disorder

Not Applicable

Recruiting

• Conditions: Shift-work Disorder
• Interventions: Behavioral: Phototherapy

• Registration Number: NCT05186233
• Lead Sponsor: Henry Ford Health System

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.

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 Timeline

• Study First Submitted: 2021-12-15
• Study First Submitted QC: 2022-01-06
• Study First Posted: 2022-01-11
• Study Start: 2022-04-18
• Status Verified: 2023-07
• Last Update Submitted: 2023-07-18
• Last Update Posted: 2023-07-20
• Primary Completion: 2025-01-31
• Study Completion: 2025-01-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 50

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Personalized light condition	Phototherapy	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.
Non-personalized light condition	Phototherapy	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.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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)
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)

Trial Locations

Locations (1)

Henry Ford Columbus Medical Center; 🇺🇸 Novi, Michigan, United States