Skip to main content
OpenTrials
Completed

NCT Number: NCT05186233

Use of Consumer Sleep Technology to Treat Shift Work Disorder

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Henry Ford Columbus Medical Center

Novi, Michigan, 48377, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Phototherapy

Behavioral

Light exposure recommendations provided by SHIFT mobile application

Primary outcomes

  1. Dim light melatonin onset

    Time frame: 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 outcomes

  1. Insomnia

    Time frame: Within one week of post-treatment

    Insomnia will be measured with the Insomnia Severity Scale (0 to 28; higher scores correspond to worse severity)

  2. Daytime sleepiness

    Time frame: 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)

Sponsors and collaborators

Lead sponsor

Henry Ford Health System

Other

Collaborators

  • American Academy of Sleep Medicine

Registry information

Official study title

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

Acronym: SHIFT

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Jan 11, 2022
Registry last updated
Jun 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.