Role of Sleep Reactivity in Shift Work Disorder

NCT05424406 | Recruiting DMC

• 2 other identifiers: 15661R01HL160870
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

Shift-work Disorder

Keywords

Sleep reactivity

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (2)

• Insomnia

  Within one week of post-treatment

• Sleepiness

  Within one week of post-treamtnet

Study Arms (4)

Active light condition

EXPERIMENTAL

Timed bright light exposure will be delivered in a controlled laboratory setting (10,000 lux) designed to delay the DLMO to 4 am or later. This would shift the circadian nadir (e.g., the period of maximal sleepiness) into the typical daytime sleep period after the nightshift (i.e., circadian nadir at \~10am). Bright light will be delivered in a controlled lab environment using a full spectrum light-box with UV filter (Sunbox Sunray II) to achieve a robust reduction of circadian misalignment. The light schedule will be tailored to each individual nightshift worker, determined by: 1) their baseline circadian phase, and 2) the human phase response curve adjusted to the individual's baseline circadian phase.

Behavioral: Active phototherapy

Control light condition

ACTIVE COMPARATOR

Shift workers randomized to the control condition will receive less intense light that still has a perceptible alerting effect (100 photopic lux). However, light will occur during a portion of the phase response curve with minimal phase shifts.

Behavioral: Control phototherapy

Cognitive Behavioral Therapy (CBT) condition

EXPERIMENTAL

The CBT condition will probe sleep reactivity using validated CBT strategies over 6 sessions in accordance with the two-factor theory of emotion. Behavioral strategies will be used to reduce physiological arousal (e.g., relaxation training, breathing) and to strengthen behavioral cues for sleep (e.g., sleep hygiene and sleep scheduling). Sleep times will be scheduled to align with the reduced circadian misalignment (compromised phase position, i.e., maintaining a slightly delayed sleep period on offwork days). 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: Cognitive Behavioral Therapy (CBT)

Sleep education control condition

ACTIVE COMPARATOR

This condition will use an established sleep education control protocol modified for nightshift workers based on the "Plain Language about Shiftwork" published by the National Institute for Occupational Safety and Health (NIOSH). 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.

Behavioral: Sleep education control

Interventions

Active phototherapy BEHAVIORAL

Timed bright light exposure delivered in a controlled laboratory setting (10,000 photopic lux) designed to delay the DLMO to 4 am or later.

Active light condition

Control phototherapy BEHAVIORAL

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.

Control light condition

Cognitive Behavioral Therapy (CBT) BEHAVIORAL

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.

Cognitive Behavioral Therapy (CBT) condition

Sleep education control BEHAVIORAL

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.

Sleep education control condition

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Henry Ford Health System: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (1)

Henry Ford Columbus Medical Center

Novi, Michigan, 48377, United States

RECRUITING

MeSH Terms

Interventions

Cognitive Behavioral Therapy

Intervention Hierarchy (Ancestors)

Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Central Study Contacts

Philip Cheng, PhD

CONTACT

248-344-7361; pcheng1@hfhs.org

Marleigh Treger, BS

CONTACT

248-344-8028; mtreger1@hfhs.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: OTHER
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: 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.

Study Record Dates

• First Submitted: June 15, 2022
• First Posted: June 21, 2022
• Study Start: January 1, 2023
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): October 1, 2027
• Last Updated: October 14, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)