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

Henry Ford Health

Status: Completed

Conditions: Shift-work Disorder

Treatments: Behavioral: Phototherapy

Study type: Interventional

Funder types: Other

Identifiers

NCT05186233

15108

Details and patient eligibility

About

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.

Full 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.

Enrollment: 63 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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63 participants in 2 patient groups

Non-personalized light condition

Active Comparator group

Description:

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.

Treatment:

Behavioral: Phototherapy

Personalized light condition

Experimental group

Description:

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.

Treatment:

Behavioral: Phototherapy