Investigating how sleep reactivity affects shift work disorder
Sleep Reactivity as a Novel Mechanism in Shift Work Disorder
NA · Henry Ford Health System · NCT05424406
This study is testing if how sensitive your sleep is can cause Shift Work Disorder and if treating sleep issues with therapy can help people who still have problems after adjusting their sleep schedule.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 150 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Henry Ford Health System (other) |
| Locations | 1 site (Novi, Michigan) |
| Trial ID | NCT05424406 on ClinicalTrials.gov |
What this trial studies
This project aims to test the role of sleep reactivity as an independent cause of Shift Work Disorder (SWD). It will involve a two-step mechanistic randomized controlled trial design with 150 participants who have SWD and varying levels of sleep reactivity. The first step will experimentally reduce circadian misalignment, while the second step will assess the impact of Cognitive Behavioral Therapy (CBT) on those who remain symptomatic. The study seeks to establish sleep reactivity as a predictor of insomnia and sleepiness in SWD, independent of circadian factors.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older who work fixed night shifts and have been diagnosed with Shift Work Disorder.
Not a fit: Patients with pre-existing insomnia disorders or other sleep disorders may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved treatment strategies for individuals suffering from Shift Work Disorder.
How similar studies have performed: Other studies have explored the effects of circadian misalignment and sleep reactivity, but this specific approach is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Criteria: * 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
Where this trial is running
Novi, Michigan
- Henry Ford Columbus Medical Center — Novi, Michigan, United States (RECRUITING)
Study contacts
- Study coordinator: Philip Cheng, PhD
- Email: pcheng1@hfhs.org
- Phone: 248-344-7361
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Shift-work Disorder, Sleep reactivity