Use of Consumer Sleep Technology to Treat Shift Work Disorder

NCT05186233 | Completed

• 1 other identifier: 15108
• Study Type: interventional
• Target: 63
• Locations: 1 country
• Sites: 1

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.

Conditions

Shift-work Disorder

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Insomnia

  Within one week of post-treatment

• Daytime sleepiness

  Within one week of post-treatment

Study Arms (2)

Non-personalized light condition

ACTIVE COMPARATOR

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

Personalized light condition

EXPERIMENTAL

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

Interventions

Phototherapy BEHAVIORAL

Light exposure recommendations provided by SHIFT mobile application

Non-personalized light condition; Personalized light condition

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Henry Ford Health System: lead
• American Academy of Sleep Medicine: collaborator

Study Sites (1)

Henry Ford Columbus Medical Center

Novi, Michigan, 48377, United States

Location

MeSH Terms

Interventions

Phototherapy

Intervention Hierarchy (Ancestors)

Therapeutics

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Scientist

Study Record Dates

• First Submitted: December 15, 2021
• First Posted: January 11, 2022
• Study Start: April 18, 2022
• Primary Completion: March 31, 2025
• Study Completion: March 31, 2025
• Last Updated: June 8, 2025

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)