NCT05424406

Role of Sleep Reactivity in Shift Work Disorder

Sleep Reactivity as a Novel Mechanism in Shift Work Disorder

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 150 (estimated)
• Sponsor: Henry Ford Health System · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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 symptoms after experimental reduction of circadian misalignment, which will then be mitigated with CBT.

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 a predictor of sleepiness in SWD independent from circadian misalignment. The third aim of this study is to probe sleep reactivity as a cause of insomnia in SWD. The fourth aim of this study is to probe sleep reactivity as a cause of sleepiness in SWD. Participants with Shift Work Disorder (SWD, N=150) with high and low sleep reactivity will be enrolled. This study will use a two-step mechanistic randomized controlled trial design stratified by high and low sleep reactivity to examine the independent effect of sleep reactivity in SWD after experimental reduction of circadian misalignment. The first step will experimentally reduce circadian misalignment compared to a control. Those who achieve reduced circadian misalignment (melatonin onset at or later than 4am, i.e., compromised phase position) and remain symptomatic will continue to the second step where sleep reactivity will be probed with CBT compared to a sleep education control.

Conditions

• Shift-work Disorder

Interventions

Type	Name	Description
BEHAVIORAL	Active phototherapy	Timed bright light exposure delivered in a controlled laboratory setting (10,000 photopic lux) designed to delay the DLMO to 4 am or later.
BEHAVIORAL	Control phototherapy	Timed less intense light exposure delivered in a controlled laboratory setting (100 photopic lux) that still has a perceptible alerting effect but is not designed to shift circadian phase.
BEHAVIORAL	Cognitive Behavioral Therapy (CBT)	Cognitive strategies will identify stressors (e.g., dysfunctional beliefs about sleep) and intervene on worry and rumination with cognitive reappraisal and active coping. Sessions will be conducted by a trained behavioral sleep medicine provider via telemedicine to increase accessibility.
BEHAVIORAL	Sleep education control	Sleep duration recommendations will be equivalent to the CBT group (8 hours of sleep opportunity) to ensure that outcomes are not confounded by time in bed. Materials in the sleep education control condition will be separated into weekly electronic materials monitored for engagement and completion.

Timeline

• Start date: 2023-01-01
• Primary completion: 2027-06-30
• Completion: 2027-10-01
• First posted: 2022-06-21
• Last updated: 2025-10-14

Locations

1 site across 1 country: United States