Role of Sleep Reactivity in Shift Work Disorder

Shift-work Disorder Clinical Trial

— REACT  

Official title:

Sleep Reactivity as a Novel Mechanism in Shift Work Disorder

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05424406
• Other study ID #: 15661
• Secondary ID: R01HL160870
• Status: Recruiting
• Phase: N/A
• Start date: January 1, 2023
• Est. completion date: October 1, 2027

Study information

• Verified date: March 2023
• Source: Henry Ford Health System
• Contact: Philip Cheng, PhD
• Phone: 248-344-7361
• Email: pcheng1[@]hfhs.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: October 1, 2027
• Est. primary completion date: June 30, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Disease
• Shift-work Disorder

Intervention

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.
• 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.
• 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.
• 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.

Locations

Country	Name	City	State
United States	Henry Ford Columbus Medical Center	Novi	Michigan

Sponsors (2)

Lead Sponsor	Collaborator
Henry Ford Health System	National Heart, Lung, and Blood Institute (NHLBI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Dim light melatonin onset	Melatonin values will be measured in saliva samples, collected in dim light conditions in a laboratory, to determine circadian phase.	Within two days of treatment for a duration of 24 hours
Primary	Sleep reactivity	Sleep reactivity will be measured using the validated Ford Insomnia Response to Stress Test (FIRST). Based on psychometric testing of the FIRST, a cutoff score of 16 will distinguish high and low sleep reactivity.	Within two weeks of treatment
Secondary	Insomnia	Insomnia will be measured with the Insomnia Severity Scale (0 to 28; higher scores correspond to worse severity)	Within one week of post-treatment
Secondary	Sleepiness	Sleepiness will be measured with the Epworth Sleepiness Scale (0 to 24; a score of 10 or greater indicates excessive sleepiness).	Within one week of post-treamtnet