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NCT Number: NCT05424406

Role of Sleep Reactivity in Shift Work Disorder

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.

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Key information

Conditions

Shift-work Disorder

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

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.

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.

Primary outcomes

  1. Dim light melatonin onset

    Time frame: Within two days of treatment for a duration of 24 hours

    Melatonin values will be measured in saliva samples, collected in dim light conditions in a laboratory, to determine circadian phase.

  2. Sleep reactivity

    Time frame: Within two weeks of treatment

    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.

Secondary outcomes

  1. Insomnia

    Time frame: Within one week of post-treatment

    Insomnia will be measured with the Insomnia Severity Scale (0 to 28; higher scores correspond to worse severity)

  2. Sleepiness

    Time frame: Within one week of post-treamtnet

    Sleepiness will be measured with the Epworth Sleepiness Scale (0 to 24; a score of 10 or greater indicates excessive sleepiness).

Study contacts

Contact information is provided by the study sponsor or research team.

Marleigh Treger, BS

CONTACT

[email protected]

248-344-8028

Philip Cheng, PhD

CONTACT

[email protected]

248-344-7361

Sponsors and collaborators

Lead sponsor

Henry Ford Health System

Other

Collaborators

  • National Heart, Lung, and Blood Institute (NHLBI)

Registry information

Official study title

Sleep Reactivity as a Novel Mechanism in Shift Work Disorder

Acronym: REACT

Important dates

Study start
2023
Primary completion
2027
Study completion
2027
First posted
Jun 21, 2022
Registry last updated
Oct 14, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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