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Light Therapy + Cognitive Behavioral Therapy for Shift Work Sleep Disorder (REACT Trial)

N/A

Recruiting

Research Sponsored by Henry Ford Health System

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Participants must be working a fixed nightshift schedule, operationalized as working at least three night shifts a week with shifts beginning between 18:00 and 02:00, lasting between 8 to 12 hours, and planning to maintain the nightshift schedule for the study duration

Participants must be at least 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up within two days of treatment for a duration of 24 hours

Awards & highlights

REACT Trial Summary

This trial is testing if sleep reactivity is a cause of Shift Work Disorder, and if so, if reducing circadian misalignment will help.

Who is the study for?

This trial is for adults over 18 who work at least three night shifts per week, starting between 6 PM and 2 AM, lasting 8-12 hours. They must have Shift Work Disorder diagnosed by specific criteria and show a certain pattern of sleep hormone timing. Excluded are those with bipolar or neurological disorders, pregnant women, other sleep disorders, drug or alcohol abuse issues, or insomnia predating shift work.Check my eligibility

What is being tested?

The study tests if high sleep reactivity causes persistent Shift Work Disorder symptoms after reducing circadian misalignment. It involves comparing active phototherapy and Cognitive Behavioral Therapy (CBT) against control phototherapy and basic sleep education to see which helps better.See study design

What are the potential side effects?

Potential side effects from the interventions may include eye strain or headache from phototherapy and temporary discomfort when adjusting to new sleeping habits as part of CBT.

REACT Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I work night shifts starting between 6 PM and 2 AM for at least three nights a week.

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I am 18 years old or older.

REACT Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ within two days of treatment for a duration of 24 hours

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~within two days of treatment for a duration of 24 hours

This trial's timeline: 3 weeks for screening, Varies for treatment, and within two days of treatment for a duration of 24 hours for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Dim light melatonin onset

Sleep reactivity

Secondary outcome measures

Insomnia

Sleepiness

Side effects data

From 2018 Phase 4 trial • 95 Patients • NCT01041274

18%

Weight increase

10%

Tachycardia

Psychiatric Hospitalization

Hypertension

Loss of libido

Concentration impaired

Appetite increase

Memory impaired

Rash

Restlessness

Amenorrhea

Drooling

Dizziness upon standing

Apathy

Sleep disturbed

Anorgasmia

Blurred vision

Drug abuse

Akathisia

Appetite decrease

Drug-related hospitalization

Cellulitis

Hot flashes

Medical Hospitalization

Fatigue

Hiccup

Hit by a motorcycle

Hurt when riding a bike

Mental activity decreased

Muscle twitch

Sleeplessness

Pneumonia

Nightmares

Teeth grating

Incarceration

Sensory hallucinations

100%

80%

60%

40%

20%

Study treatment Arm

Placebo

Citalopram

REACT Trial Design

4Treatment groups

Experimental Treatment

Active Control

Group I: Cognitive Behavioral Therapy (CBT) conditionExperimental Treatment1 Intervention

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.

Group II: Active light conditionExperimental Treatment1 Intervention

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.

Group III: Control light conditionActive Control1 Intervention

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.

Group IV: Sleep education control conditionActive Control1 Intervention

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Cognitive Behavioral Therapy (CBT)

2008

Completed Phase 4

~3620

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Henry Ford Health SystemLead Sponsor

300 Previous Clinical Trials

2,099,732 Total Patients Enrolled

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

3,838 Previous Clinical Trials

47,851,504 Total Patients Enrolled

Media Library

Cognitive Behavioral Therapy (CBT) Clinical Trial Eligibility Overview. Trial Name: NCT05424406 — N/A

Shift Work Sleep Disorder Research Study Groups: Active light condition, Control light condition, Cognitive Behavioral Therapy (CBT) condition, Sleep education control condition

Shift Work Sleep Disorder Clinical Trial 2023: Cognitive Behavioral Therapy (CBT) Highlights & Side Effects. Trial Name: NCT05424406 — N/A

Cognitive Behavioral Therapy (CBT) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05424406 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any more slots available for this experiment?

"Information located on clinicaltrials.gov reveals that this research is not actively seeking patients at the current moment in time, despite having been originally posted to the website on April 1st 2023 and last updated August 9th 2022. However, there are presently 929 other trials which are still recruiting participants."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Role of Sleep Reactivity in Shift Work Disorder

Philip Cheng 2023. "Role of Sleep Reactivity in Shift Work Disorder". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05424406.