Clinical trial NCT05424406: Role of Sleep Reactivity in Shift Work Disorder
Official title: Sleep Reactivity as a Novel Mechanism in Shift Work Disorder
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Shift-work Disorder
Keywords: Sleep reactivity
Lead sponsor: Henry Ford Health System
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2022-06-21
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: Two-step mechanistic randomized controlled trial design stratified by high and low sleep reactivity. Step 1: active versus control light therapy; Step 2: Cognitive Behavioral Therapy (CBT) versus sleep education control.
Primary purpose: OTHER

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 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.

Eligibility 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

Primary outcomes:
measure: Dim light melatonin onset
timeFrame: Within two days of treatment for a duration of 24 hours
measure: Sleep reactivity
timeFrame: Within two weeks of treatment
Secondary outcomes:
measure: Insomnia
timeFrame: Within one week of post-treatment
measure: Sleepiness
timeFrame: Within one week of post-treamtnet
Other outcomes:
Locations:
city: Novi
country: United States
facility: Henry Ford Columbus Medical Center
state: Michigan
Study officials:
References: