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| Name | Class |
|---|---|
| U.S. Army Medical Research Acquisition Activity | FED |
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Sleep disturbance is nearly ubiquitous among individuals suffering from PTSD and is a major problem among service members returning from combat deployments. The proposed study aims to test a novel, inexpensive, and easy to use approach to improving sleep among service members with PTSD.
Primary outcome measures will include not only PTSD symptom improvement but also include neuroimaging of brain structure, function, connectivity, and neurochemistry changes. The proposal is firmly grounded in the emerging scientific literature regarding sleep, light exposure, brain function, anxiety, and resilience. Prior evidence suggests that bright light therapy is effective for improving mood and fatigue, and our pilot data further suggest that this treatment may be effective for improving daytime sleepiness and brain functioning in brain injured individuals. Thus, this intervention, in our own research and in the work of others, has been shown to affect critical sleep regulatory systems. Improving sleep may be a vital component of recovery in these service members. Our approach would directly address this issue. Our preliminary data have shown that this approach is extremely well tolerated and is effective for improving sleep, mood, cognitive performance, and brain function among individuals with brain injuries.
Finally, the potential impact of this study is high because of the capability of transitioning the research to direct clinical application almost immediately. If the bright light treatment is demonstrated as effective, this approach would be readily available for nearly immediate large-scale implementation, as the devices have been widely used for years in other contexts, are already safety tested, and commercially available from several manufacturers for a very low cost. Thus, the impact of this research on treating PTSD would be high and immediate.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PTSD wavelength-1 bright light | Experimental | 30 minutes of daily light exposure for 6 weeks |
|
| PTSD wavelength-2 bright light | Placebo Comparator | 30 minutes of daily light exposure for 6 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PTSD wavelength-1 bright light | Device | 6 weeks of daily light exposure, 30 minutes per morning. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Sleep Efficiency | Actigraphy was used as a measurement of individual sleep efficiency calculating total sleep time (minutes asleep) divided by total rest time (time in bed- minutes in bed). This produces a percentage efficiency calculation that can range 0-100%, higher percentages indicates more time asleep while in bed. | Sleep Efficiency was calculated at Baseline (Pre-Treatment) and Post-Treatment (6 Weeks after Baseline) |
| Subjective Sleep Quality | Pittsburgh Sleep Quality Index is a measurement of subjective self-report sleep quality that uses both free response and Likert scale responses. The range of scores possible are 0 to 21. Higher scores indicate worse subjective sleep quality. | Results 6 weeks post-treatment |
| Neural Activation During Functional Magnetic Resonance Imaging (fMRI) Emotion Processing Task | Activation of medial prefrontal cortex and anterior cingulate cortex (also prefrontal) during functional magnetic resonance imaging (fMRI) Backward Masked Affect Task (BMAT) emotion processing task. Contrast weight/effect scores for prefrontal area [MNI coordinates: 18,42,12] measured contrasts in activation between neutral images and activation when emotional images (fear images) were presented during the task. Higher scores indicate a greater difference or contrast between the neutral signal and emotional signal during the fMRI task. | Baseline (Pre-Treatment) and Post-Treatment (6 Weeks after Baseline) |
| Performance on Neuropsychological Assessment | The Repeatable Battery for the Assessment of Neuropsychological Status will be utilized to measure overall neurocognitive performance. It covers five domains of cognition: Immediate Memory, Visuospatial/Constructional, Language, Attention, and Delayed Memory resulting in a total neurocognitive performance score. The range of overall total neurocognitive performance scores is 40-160 points. Higher scores on this scale represent a higher capacity for executive function. |
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Further eligibility will be determined through a phone screening. Please call (520) 626-8591 or go to uascanlab.com to check your eligibility for this study.
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| Name | Affiliation | Role |
|---|---|---|
| William Killgore, Ph.D. | University of Arizona | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Arizona Psychiatry Department | Tucson | Arizona | 85724 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | PTSD Wavelength-1 Amber | 30 minutes of daily light exposure for 6 weeks PTSD wavelength-1 bright light: 6 weeks of daily light exposure, 30 minutes per morning. |
| FG001 | PTSD Wavelength-2 Blue | 30 minutes of daily light exposure for 6 weeks PTSD wavelength-2 bright light: 6 weeks daily light exposure, 30 minutes per morning. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | PTSD Wavelength-1 Amber | 30 minutes of daily light exposure for 6 weeks PTSD wavelength-1 bright light: 6 weeks of daily light exposure, 30 minutes per morning. |
| BG001 | PTSD Wavelength-2 Blue |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Sleep Efficiency | Actigraphy was used as a measurement of individual sleep efficiency calculating total sleep time (minutes asleep) divided by total rest time (time in bed- minutes in bed). This produces a percentage efficiency calculation that can range 0-100%, higher percentages indicates more time asleep while in bed. | Because the rows in the outcome measure data table correspond to different timepoints, and because in some cases, data from certain measures were unusable, the number of individuals analyzed at each timepoint differs from the overall number analyzed (i.e. the number of unique individuals whose data were factored into the below descriptive statistics). | Posted | Mean | Standard Deviation | Percentage of Sleep | Sleep Efficiency was calculated at Baseline (Pre-Treatment) and Post-Treatment (6 Weeks after Baseline) |
|
7 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | PTSD Wavelength-1 Amber | 30 minutes of daily light exposure for 6 weeks PTSD wavelength-1 bright light: 6 weeks of daily light exposure, 30 minutes per morning. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. William D. "Scott" Killgore | University of Arizona | (520) 621-0605 | killgore@arizona.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 1, 2014 | Sep 13, 2022 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D013313 | Stress Disorders, Post-Traumatic |
| D020447 | Parasomnias |
| ID | Term |
|---|---|
| D040921 | Stress Disorders, Traumatic |
| D000068099 | Trauma and Stressor Related Disorders |
| D001523 | Mental Disorders |
| D012893 | Sleep Wake Disorders |
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| PTSD wavelength-2 bright light | Device | 6 weeks daily light exposure, 30 minutes per morning. |
|
| Performance results at 6 weeks post-treatment. |
| PTSD Symptoms | Post Traumatic Stress Disorder Checklist 5 (PCL-5).The PTSD Checklist for DSM-5 is a 20-item self-report measure that assesses the presence and severity of PTSD symptoms. Items are summed to provide a total severity score (range = 0-80). Higher scores indicate greater presence or severity of PTSD symptoms. | Performance results at 6 weeks post-treatment. |
| Daytime Sleepiness (ESS) | Epworth Sleepiness Scale is a subjective measure of daytime sleepiness. This is on a 4-point Likert scale, each item has a range of 0 to 3 points. The total score range for this is 0-24 points. Higher scores indicate more severe daytime sleepiness. | Performance results at 6 weeks post-treatment |
| Daytime Sleepiness (SSS) | Stanford Sleepiness Scale is a one item scale assessing current level of alertness. The range of points possible is 1-7, with higher scores indicating that sleep onset is soon. This scale was given at three different time points during baseline assessment and post treatment. | Performance results at 6 weeks post-treatment. |
| Daytime Sleepiness (MSLT) | Multiple Sleep Latency Test (MSLT). Participants were administered a modified Multiple Sleep Latency Test. In the multiple sleep latency test (MSLT), the participant was given 3 opportunities to nap for 20 minutes every two hours. Sleep latency scores are calculated in the number of seconds to fall asleep during their mandated sleep session. Range is from 0 seconds to 1200 seconds. | Change from baseline performance at 6 weeks (post-treatment) |
30 minutes of daily light exposure for 6 weeks
PTSD wavelength-2 bright light: 6 weeks daily light exposure, 30 minutes per morning.
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | PTSD Wavelength-2 Bright Light | 30 minutes of daily light exposure for 6 weeks PTSD wavelength-2 bright light: 6 weeks daily light exposure, 30 minutes per morning. |
|
|
| Primary | Subjective Sleep Quality | Pittsburgh Sleep Quality Index is a measurement of subjective self-report sleep quality that uses both free response and Likert scale responses. The range of scores possible are 0 to 21. Higher scores indicate worse subjective sleep quality. | Because the rows in the outcome measure data table correspond to different timepoints, and because in some cases, data from certain measures were unusable, the number of individuals analyzed at each timepoint differs from the overall number analyzed (i.e. the number of unique individuals whose data were factored into the below descriptive statistics). | Posted | Mean | Standard Deviation | score on a scale | Results 6 weeks post-treatment |
|
|
|
| Primary | Neural Activation During Functional Magnetic Resonance Imaging (fMRI) Emotion Processing Task | Activation of medial prefrontal cortex and anterior cingulate cortex (also prefrontal) during functional magnetic resonance imaging (fMRI) Backward Masked Affect Task (BMAT) emotion processing task. Contrast weight/effect scores for prefrontal area [MNI coordinates: 18,42,12] measured contrasts in activation between neutral images and activation when emotional images (fear images) were presented during the task. Higher scores indicate a greater difference or contrast between the neutral signal and emotional signal during the fMRI task. | Posted | Mean | Standard Error | Arbitrary units | Baseline (Pre-Treatment) and Post-Treatment (6 Weeks after Baseline) |
|
|
|
| Primary | Performance on Neuropsychological Assessment | The Repeatable Battery for the Assessment of Neuropsychological Status will be utilized to measure overall neurocognitive performance. It covers five domains of cognition: Immediate Memory, Visuospatial/Constructional, Language, Attention, and Delayed Memory resulting in a total neurocognitive performance score. The range of overall total neurocognitive performance scores is 40-160 points. Higher scores on this scale represent a higher capacity for executive function. | Because the rows in the outcome measure data table correspond to different timepoints, and because in some cases, data from certain measures were unusable, the number of individuals analyzed at each timepoint differs from the overall number analyzed (i.e. the number of unique individuals whose data were factored into the below descriptive statistics). | Posted | Mean | Standard Deviation | Points | Performance results at 6 weeks post-treatment. |
|
|
|
| Primary | PTSD Symptoms | Post Traumatic Stress Disorder Checklist 5 (PCL-5).The PTSD Checklist for DSM-5 is a 20-item self-report measure that assesses the presence and severity of PTSD symptoms. Items are summed to provide a total severity score (range = 0-80). Higher scores indicate greater presence or severity of PTSD symptoms. | Posted | Mean | Standard Deviation | score on a scale | Performance results at 6 weeks post-treatment. |
|
|
|
| Primary | Daytime Sleepiness (ESS) | Epworth Sleepiness Scale is a subjective measure of daytime sleepiness. This is on a 4-point Likert scale, each item has a range of 0 to 3 points. The total score range for this is 0-24 points. Higher scores indicate more severe daytime sleepiness. | Because the rows in the outcome measure data table correspond to different timepoints, and because in some cases, data from certain measures were unusable, the number of individuals analyzed at each timepoint differs from the overall number analyzed (i.e. the number of unique individuals whose data were factored into the below descriptive statistics). | Posted | Mean | Standard Deviation | score on a scale | Performance results at 6 weeks post-treatment |
|
|
|
| Primary | Daytime Sleepiness (SSS) | Stanford Sleepiness Scale is a one item scale assessing current level of alertness. The range of points possible is 1-7, with higher scores indicating that sleep onset is soon. This scale was given at three different time points during baseline assessment and post treatment. | Posted | Mean | Standard Deviation | units on a scale | Performance results at 6 weeks post-treatment. |
|
|
|
| Primary | Daytime Sleepiness (MSLT) | Multiple Sleep Latency Test (MSLT). Participants were administered a modified Multiple Sleep Latency Test. In the multiple sleep latency test (MSLT), the participant was given 3 opportunities to nap for 20 minutes every two hours. Sleep latency scores are calculated in the number of seconds to fall asleep during their mandated sleep session. Range is from 0 seconds to 1200 seconds. | Posted | Mean | Standard Deviation | seconds | Change from baseline performance at 6 weeks (post-treatment) |
|
|
|
| 0 |
| 43 |
| 0 |
| 43 |
| 0 |
| 43 |
| EG001 | PTSD Wavelength-2 Blue | 30 minutes of daily light exposure for 6 weeks PTSD wavelength-2 bright light: 6 weeks daily light exposure, 30 minutes per morning. | 0 | 47 | 0 | 47 | 0 | 47 |
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| D009422 | Nervous System Diseases |
| Post-Treatment |
|
|
| Post-Treatment |
|
|
| Post-Treatment |
|
|
| Baseline - Administration 3 |
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| Post-Treatment - Administration 1 |
|
| Post-Treatment - Administration 2 |
|
| Post-Treatment - Administration 3 |
|
| Mean Sleep Latency in Seconds For Third Administered Nap at Baseline Visit |
|
| Mean Sleep Latency in Seconds For First Administered Nap while receiving Bright Light |
|
| Mean Sleep Latency in Seconds For Second Administered Nap while receiving Bright Light |
|
| Mean Sleep Latency in Seconds For Third Administered Nap while receiving Bright Light |
|