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Use of Consumer Sleep Technology to Treat Shift Work Disorder

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05186233
Acronym
SHIFT
Enrollment
63
Registered
2022-01-11
Start date
2022-04-18
Completion date
2025-03-31
Last updated
2025-06-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Shift-work Disorder

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.

Interventions

BEHAVIORALPhototherapy

Light exposure recommendations provided by SHIFT mobile application

Sponsors

American Academy of Sleep Medicine
CollaboratorOTHER
Henry Ford Health System
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Dim light melatonin onsetWithin two days of treatment for a duration of 24 hoursMelatonin values will be measured in saliva samples, collected in dim light conditions in a laboratory, to determine circadian phase.

Secondary

MeasureTime frameDescription
InsomniaWithin one week of post-treatmentInsomnia will be measured with the Insomnia Severity Scale (0 to 28; higher scores correspond to worse severity)
Daytime sleepinessWithin one week of post-treatmentSleepiness will be measured with the Epworth Sleepiness Scale (0 to 24; a score of 10 or greater indicates excessive daytime sleepiness)

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026