Status:
RECRUITING
Role of Sleep Reactivity in Shift Work Disorder
Lead Sponsor:
Henry Ford Health System
Collaborating Sponsors:
National Heart, Lung, and Blood Institute (NHLBI)
Conditions:
Shift-work Disorder
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The purpose of this project is to test sleep reactivity as an independent cause of Shift Work Disorder (SWD). The primary hypothesis is that those with high sleep reactivity will show persistent SWD s...
Detailed Description
The first aim of this study is to establish sleep reactivity as a predictor of insomnia in SWD independent from circadian misalignment. The second aim of this study is to establish sleep reactivity as...
Eligibility Criteria
Inclusion
- Participants must be working a fixed nightshift schedule, operationalized as: a) working at least three night shifts a week, b) shifts must begin between 18:00 and 02:00, and last between 8 to 12 hours, and c) must also plan to maintain the nightshift schedule for the duration of the study
- Participants must have Shift Work Disorder, which will be diagnosed based on ICSD-3 criteria
- Participants must show circadian misalignment, operationalized as a baseline melatonin onset between 18:00 and 01:00.
- Participants must be at least 18 years old
Exclusion
- Insomnia disorder or excessive sleepiness predating the onset of shift work
- Termination of nightshift schedule
- Presence of other sleep disorders (e.g. obstructive sleep apnea, narcolepsy) determined by standard clinical polysomnography
- Diagnosis of bipolar disorder
- History of neurological disorders determined by self-report and medical history
- Pregnancy
- Alcohol use disorder
- Illicit drug use via self-report and urine drug screen if reasonable suspicion to test
Key Trial Info
Start Date :
January 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2027
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT05424406
Start Date
January 1 2023
End Date
October 1 2027
Last Update
October 14 2025
Active Locations (1)
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1
Henry Ford Columbus Medical Center
Novi, Michigan, United States, 48377