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| ID | Type | Description | Link |
|---|---|---|---|
| R01HL160870 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Heart, Lung, and Blood Institute (NHLBI) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Sleepiness | Sleepiness will be measured with the Epworth Sleepiness Scale (0 to 24; a score of 10 or greater indicates excessive sleepiness). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Philip Cheng, PhD | Contact | 248-344-7361 | pcheng1@hfhs.org | |
| Marleigh Treger, BS | Contact | 248-344-8028 | mtreger1@hfhs.org |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Henry Ford Columbus Medical Center | Recruiting | Novi | Michigan | 48377 | United States |
Request for data sharing will be evaluated on a case-by-case basis.
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| ID | Term |
|---|---|
| D015928 | Cognitive Behavioral Therapy |
| ID | Term |
|---|---|
| D001521 | Behavior Therapy |
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
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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.
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| 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. |
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| 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. |
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| 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. |
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| 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. |
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| Within one week of post-treamtnet |