Role of Sleep Reactivity in Shift Work Disorder
ConditionShift-work Disorder
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorHenry Ford Health System
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Sequential
Treatments tested in this trial
Active phototherapy
BehavioralTimed 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
BehavioralTimed 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)
BehavioralCognitive 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
BehavioralSleep 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 groups
150 Participants
are divided into 4 treatment groupsGroup A: Active light conditionExperimental treatment 1 intervention
Group B: Control light conditionActive comparator 1 intervention
Group C: Cognitive Behavioral Therapy (CBT) conditionExperimental treatment 1 intervention
Group D: Sleep education control conditionActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Dim light melatonin onset
Melatonin values will be measured in saliva samples, collected in dim light conditions in a laboratory, to determine circadian phase.
Time frame
Within two days of treatment for a duration of 24 hours2
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.
Time frame
Within two weeks of treatmentSecondary outcomes
1
Insomnia
Insomnia will be measured with the Insomnia Severity Scale (0 to 28; higher scores correspond to worse severity)
Time frame
Within one week of post-treatment2
Sleepiness
Sleepiness will be measured with the Epworth Sleepiness Scale (0 to 24; a score of 10 or greater indicates excessive sleepiness).
Time frame
Within one week of post-treamtnetSponsors and contacts
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Henry Ford Health System
Lead sponsor
National Heart, Lung, and Blood Institute (NHLBI)
Collaborator
Source ClinicalTrials.gov