Use of Consumer Sleep Technology to Treat Shift Work Disorder

Shift-work Disorder Clinical Trial

— SHIFT  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05186233
• Other study ID #: 15108
• Status: Recruiting
• Phase: N/A
• Start date: April 18, 2022
• Est. completion date: January 31, 2025

Study information

• Verified date: July 2023
• Source: Henry Ford Health System
• Contact: Philip Cheng, PhD
• Phone: 248-344-7361
• Email: pcheng1[@]hfhs.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: January 31, 2025
• Est. primary completion date: January 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Shift-work Disorder

Intervention

Behavioral:
• Phototherapy
Light exposure recommendations provided by SHIFT mobile application

Locations

Country	Name	City	State
United States	Henry Ford Columbus Medical Center	Novi	Michigan

Sponsors (2)

Lead Sponsor	Collaborator
Henry Ford Health System	American Academy of Sleep Medicine

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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