PTSD, Sleep Problems
Conditions
Keywords
PTSD, Stress, Sleep Problems, Brain imaging, fMRI
Brief summary
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.
Interventions
6 weeks of daily light exposure, 30 minutes per morning.
6 weeks daily light exposure, 30 minutes per morning.
Sponsors
Study design
Eligibility
Inclusion criteria
* Having experienced a traumatic event within the past 10 years * Right handedness * 18-50 years old * Primary language is English * No metal in body 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Sleep Efficiency | Sleep Efficiency was calculated at Baseline (Pre-Treatment) and Post-Treatment (6 Weeks after Baseline) | 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. |
| Subjective Sleep Quality | Results 6 weeks post-treatment | 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. |
| Neural Activation During Functional Magnetic Resonance Imaging (fMRI) Emotion Processing Task | Baseline (Pre-Treatment) and Post-Treatment (6 Weeks after Baseline) | 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. |
| Performance on Neuropsychological Assessment | Performance results at 6 weeks post-treatment. | 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. |
| PTSD Symptoms | Performance results at 6 weeks post-treatment. | 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. |
| Daytime Sleepiness (ESS) | Performance results at 6 weeks post-treatment | 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. |
| Daytime Sleepiness (SSS) | Performance results at 6 weeks post-treatment. | 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. |
| Daytime Sleepiness (MSLT) | Change from baseline performance at 6 weeks (post-treatment) | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 43 |
| 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. | 47 |
| Total | 90 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Protocol Violation | 1 | 1 |
| Overall Study | Withdrawal by Subject | 2 | 2 |
Baseline characteristics
| Characteristic | PTSD Wavelength-2 Blue | Total | PTSD Wavelength-1 Amber |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 47 Participants | 90 Participants | 43 Participants |
| Age, Continuous | 32.02 years STANDARD_DEVIATION 8.99 | 31.38 years STANDARD_DEVIATION 8.9 | 30.07 years STANDARD_DEVIATION 8.39 |
| Race/Ethnicity, Customized Asian/Pacific Islander | 1 Participants | 1 Participants | 0 Participants |
| Race/Ethnicity, Customized Black/African American | 2 Participants | 4 Participants | 2 Participants |
| Race/Ethnicity, Customized Hispanic/Latino | 9 Participants | 17 Participants | 8 Participants |
| Race/Ethnicity, Customized Native American/American Indian | 0 Participants | 3 Participants | 3 Participants |
| Race/Ethnicity, Customized Other | 4 Participants | 6 Participants | 2 Participants |
| Race/Ethnicity, Customized White | 31 Participants | 59 Participants | 28 Participants |
| Region of Enrollment United States | 47 participants | 90 participants | 43 participants |
| Sex: Female, Male Female | 16 Participants | 30 Participants | 14 Participants |
| Sex: Female, Male Male | 31 Participants | 60 Participants | 29 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 43 | 0 / 47 |
| other Total, other adverse events | 0 / 43 | 0 / 47 |
| serious Total, serious adverse events | 0 / 43 | 0 / 47 |
Outcome results
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.
Time frame: Performance results at 6 weeks post-treatment
Population: 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).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| PTSD Wavelength-1 Bright Light | Daytime Sleepiness (ESS) | Baseline | 9.93 score on a scale | Standard Deviation 4.46 |
| PTSD Wavelength-1 Bright Light | Daytime Sleepiness (ESS) | Post-Treatment | 8.82 score on a scale | Standard Deviation 4.13 |
| PTSD Wavelength-2 Bright Light | Daytime Sleepiness (ESS) | Baseline | 9.61 score on a scale | Standard Deviation 4.05 |
| PTSD Wavelength-2 Bright Light | Daytime Sleepiness (ESS) | Post-Treatment | 8.82 score on a scale | Standard Deviation 3.77 |
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.
Time frame: Change from baseline performance at 6 weeks (post-treatment)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| PTSD Wavelength-1 Bright Light | Daytime Sleepiness (MSLT) | Mean Sleep Latency in Seconds For First Administered Nap at Baseline Visit | 486.84 seconds | Standard Deviation 359.27 |
| PTSD Wavelength-1 Bright Light | Daytime Sleepiness (MSLT) | Mean Sleep Latency in Seconds For Second Administered Nap at Baseline Visit | 334.05 seconds | Standard Deviation 271.12 |
| PTSD Wavelength-1 Bright Light | Daytime Sleepiness (MSLT) | Mean Sleep Latency in Seconds For Third Administered Nap at Baseline Visit | 489.20 seconds | Standard Deviation 411.4 |
| PTSD Wavelength-1 Bright Light | Daytime Sleepiness (MSLT) | Mean Sleep Latency in Seconds For First Administered Nap while receiving Bright Light | 597.63 seconds | Standard Deviation 459.83 |
| PTSD Wavelength-1 Bright Light | Daytime Sleepiness (MSLT) | Mean Sleep Latency in Seconds For Second Administered Nap while receiving Bright Light | 481.67 seconds | Standard Deviation 400.82 |
| PTSD Wavelength-1 Bright Light | Daytime Sleepiness (MSLT) | Mean Sleep Latency in Seconds For Third Administered Nap while receiving Bright Light | 630.00 seconds | Standard Deviation 498.96 |
| PTSD Wavelength-2 Bright Light | Daytime Sleepiness (MSLT) | Mean Sleep Latency in Seconds For Second Administered Nap while receiving Bright Light | 454.74 seconds | Standard Deviation 405.23 |
| PTSD Wavelength-2 Bright Light | Daytime Sleepiness (MSLT) | Mean Sleep Latency in Seconds For First Administered Nap at Baseline Visit | 487.67 seconds | Standard Deviation 365.97 |
| PTSD Wavelength-2 Bright Light | Daytime Sleepiness (MSLT) | Mean Sleep Latency in Seconds For First Administered Nap while receiving Bright Light | 552.75 seconds | Standard Deviation 420.65 |
| PTSD Wavelength-2 Bright Light | Daytime Sleepiness (MSLT) | Mean Sleep Latency in Seconds For Second Administered Nap at Baseline Visit | 390 seconds | Standard Deviation 347.79 |
| PTSD Wavelength-2 Bright Light | Daytime Sleepiness (MSLT) | Mean Sleep Latency in Seconds For Third Administered Nap while receiving Bright Light | 494.62 seconds | Standard Deviation 382.76 |
| PTSD Wavelength-2 Bright Light | Daytime Sleepiness (MSLT) | Mean Sleep Latency in Seconds For Third Administered Nap at Baseline Visit | 520.71 seconds | Standard Deviation 408.65 |
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.
Time frame: Performance results at 6 weeks post-treatment.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| PTSD Wavelength-1 Bright Light | Daytime Sleepiness (SSS) | Baseline - Administration 1 | 3.57 units on a scale | Standard Deviation 1.48 |
| PTSD Wavelength-1 Bright Light | Daytime Sleepiness (SSS) | Baseline - Administration 2 | 3.60 units on a scale | Standard Deviation 1.38 |
| PTSD Wavelength-1 Bright Light | Daytime Sleepiness (SSS) | Baseline - Administration 3 | 3.38 units on a scale | Standard Deviation 1.409 |
| PTSD Wavelength-1 Bright Light | Daytime Sleepiness (SSS) | Post-Treatment - Administration 1 | 3.47 units on a scale | Standard Deviation 1.34 |
| PTSD Wavelength-1 Bright Light | Daytime Sleepiness (SSS) | Post-Treatment - Administration 2 | 3.79 units on a scale | Standard Deviation 1.3 |
| PTSD Wavelength-1 Bright Light | Daytime Sleepiness (SSS) | Post-Treatment - Administration 3 | 3 units on a scale | Standard Deviation 1.13 |
| PTSD Wavelength-2 Bright Light | Daytime Sleepiness (SSS) | Post-Treatment - Administration 2 | 3.35 units on a scale | Standard Deviation 1.93 |
| PTSD Wavelength-2 Bright Light | Daytime Sleepiness (SSS) | Baseline - Administration 1 | 3.80 units on a scale | Standard Deviation 1.32 |
| PTSD Wavelength-2 Bright Light | Daytime Sleepiness (SSS) | Post-Treatment - Administration 1 | 3.49 units on a scale | Standard Deviation 1.39 |
| PTSD Wavelength-2 Bright Light | Daytime Sleepiness (SSS) | Baseline - Administration 2 | 3.75 units on a scale | Standard Deviation 1.31 |
| PTSD Wavelength-2 Bright Light | Daytime Sleepiness (SSS) | Post-Treatment - Administration 3 | 2.93 units on a scale | Standard Deviation 1.26 |
| PTSD Wavelength-2 Bright Light | Daytime Sleepiness (SSS) | Baseline - Administration 3 | 3.30 units on a scale | Standard Deviation 1.13 |
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.
Time frame: Baseline (Pre-Treatment) and Post-Treatment (6 Weeks after Baseline)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| PTSD Wavelength-1 Bright Light | Neural Activation During Functional Magnetic Resonance Imaging (fMRI) Emotion Processing Task | Post-Treatment | 0.0445 Arbitrary units | Standard Error 0.0242 |
| PTSD Wavelength-1 Bright Light | Neural Activation During Functional Magnetic Resonance Imaging (fMRI) Emotion Processing Task | Baseline | 0.0158 Arbitrary units | Standard Error 0.0213 |
| PTSD Wavelength-2 Bright Light | Neural Activation During Functional Magnetic Resonance Imaging (fMRI) Emotion Processing Task | Baseline | -0.0843 Arbitrary units | Standard Error 0.0248 |
| PTSD Wavelength-2 Bright Light | Neural Activation During Functional Magnetic Resonance Imaging (fMRI) Emotion Processing Task | Post-Treatment | 0.0857 Arbitrary units | Standard Error 0.0234 |
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.
Time frame: Performance results at 6 weeks post-treatment.
Population: 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).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| PTSD Wavelength-1 Bright Light | Performance on Neuropsychological Assessment | Baseline | 89.95 Points | Standard Deviation 12.46 |
| PTSD Wavelength-1 Bright Light | Performance on Neuropsychological Assessment | Post-Treatment | 91.40 Points | Standard Deviation 13.4 |
| PTSD Wavelength-2 Bright Light | Performance on Neuropsychological Assessment | Baseline | 93.16 Points | Standard Deviation 12.46 |
| PTSD Wavelength-2 Bright Light | Performance on Neuropsychological Assessment | Post-Treatment | 95.42 Points | Standard Deviation 14.3 |
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.
Time frame: Performance results at 6 weeks post-treatment.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| PTSD Wavelength-1 Bright Light | PTSD Symptoms | Post Treatment | 7.84 score on a scale | Standard Deviation 4.4 |
| PTSD Wavelength-1 Bright Light | PTSD Symptoms | Baseline | 12.58 score on a scale | Standard Deviation 3.5 |
| PTSD Wavelength-2 Bright Light | PTSD Symptoms | Baseline | 13 score on a scale | Standard Deviation 2.91 |
| PTSD Wavelength-2 Bright Light | PTSD Symptoms | Post Treatment | 9.02 score on a scale | Standard Deviation 4.55 |
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.
Time frame: Sleep Efficiency was calculated at Baseline (Pre-Treatment) and Post-Treatment (6 Weeks after Baseline)
Population: 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).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| PTSD Wavelength-1 Bright Light | Sleep Efficiency | Baseline | 88.13 Percentage of Sleep | Standard Deviation 3.96 |
| PTSD Wavelength-1 Bright Light | Sleep Efficiency | Post-Treatment | 89.31 Percentage of Sleep | Standard Deviation 3.58 |
| PTSD Wavelength-2 Bright Light | Sleep Efficiency | Baseline | 89.95 Percentage of Sleep | Standard Deviation 3.17 |
| PTSD Wavelength-2 Bright Light | Sleep Efficiency | Post-Treatment | 89.20 Percentage of Sleep | Standard Deviation 4.03 |
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.
Time frame: Results 6 weeks post-treatment
Population: 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).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| PTSD Wavelength-1 Bright Light | Subjective Sleep Quality | Baseline | 9.08 score on a scale | Standard Deviation 3.42 |
| PTSD Wavelength-1 Bright Light | Subjective Sleep Quality | Post-Treatment | 7.53 score on a scale | Standard Deviation 3.12 |
| PTSD Wavelength-2 Bright Light | Subjective Sleep Quality | Baseline | 9.86 score on a scale | Standard Deviation 3.01 |
| PTSD Wavelength-2 Bright Light | Subjective Sleep Quality | Post-Treatment | 8.34 score on a scale | Standard Deviation 3.24 |