Trial Outcomes & Findings for A Non-Pharmacological Method for Enhancing Sleep in PTSD (NCT NCT02370173)
NCT ID: NCT02370173
Last Updated: 2023-06-23
Results Overview
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.
COMPLETED
NA
90 participants
Sleep Efficiency was calculated at Baseline (Pre-Treatment) and Post-Treatment (6 Weeks after Baseline)
2023-06-23
Participant Flow
Participant milestones
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
43
|
47
|
|
Overall Study
COMPLETED
|
40
|
44
|
|
Overall Study
NOT COMPLETED
|
3
|
3
|
Reasons for withdrawal
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
Protocol Violation
|
1
|
1
|
|
Overall Study
Withdrawal by Subject
|
2
|
2
|
Baseline Characteristics
A Non-Pharmacological Method for Enhancing Sleep in PTSD
Baseline characteristics by cohort
| Measure |
PTSD Wavelength-1 Amber
n=43 Participants
30 minutes of daily light exposure for 6 weeks
PTSD wavelength-1 bright light: 6 weeks of daily light exposure, 30 minutes per morning.
|
PTSD Wavelength-2 Blue
n=47 Participants
30 minutes of daily light exposure for 6 weeks
PTSD wavelength-2 bright light: 6 weeks daily light exposure, 30 minutes per morning.
|
Total
n=90 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
43 Participants
n=5 Participants
|
47 Participants
n=7 Participants
|
90 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
30.07 years
STANDARD_DEVIATION 8.39 • n=5 Participants
|
32.02 years
STANDARD_DEVIATION 8.99 • n=7 Participants
|
31.38 years
STANDARD_DEVIATION 8.90 • n=5 Participants
|
|
Sex: Female, Male
Female
|
14 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
29 Participants
n=5 Participants
|
31 Participants
n=7 Participants
|
60 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
28 Participants
n=5 Participants
|
31 Participants
n=7 Participants
|
59 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic/Latino
|
8 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black/African American
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian/Pacific Islander
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
2 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Native American/American Indian
|
3 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
43 participants
n=5 Participants
|
47 participants
n=7 Participants
|
90 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 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).
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.
Outcome measures
| Measure |
PTSD Wavelength-1 Bright Light
n=40 Participants
30 minutes of daily light exposure for 6 weeks
PTSD wavelength-1 bright light: 6 weeks of daily light exposure, 30 minutes per morning.
|
PTSD Wavelength-2 Bright Light
n=44 Participants
30 minutes of daily light exposure for 6 weeks
PTSD wavelength-2 bright light: 6 weeks daily light exposure, 30 minutes per morning.
|
|---|---|---|
|
Sleep Efficiency
Post-Treatment
|
89.31 Percentage of Sleep
Standard Deviation 3.58
|
89.20 Percentage of Sleep
Standard Deviation 4.03
|
|
Sleep Efficiency
Baseline
|
88.13 Percentage of Sleep
Standard Deviation 3.96
|
89.95 Percentage of Sleep
Standard Deviation 3.17
|
PRIMARY outcome
Timeframe: Results 6 weeks post-treatmentPopulation: 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).
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.
Outcome measures
| Measure |
PTSD Wavelength-1 Bright Light
n=38 Participants
30 minutes of daily light exposure for 6 weeks
PTSD wavelength-1 bright light: 6 weeks of daily light exposure, 30 minutes per morning.
|
PTSD Wavelength-2 Bright Light
n=44 Participants
30 minutes of daily light exposure for 6 weeks
PTSD wavelength-2 bright light: 6 weeks daily light exposure, 30 minutes per morning.
|
|---|---|---|
|
Subjective Sleep Quality
Baseline
|
9.08 score on a scale
Standard Deviation 3.42
|
9.86 score on a scale
Standard Deviation 3.01
|
|
Subjective Sleep Quality
Post-Treatment
|
7.53 score on a scale
Standard Deviation 3.12
|
8.34 score on a scale
Standard Deviation 3.24
|
PRIMARY outcome
Timeframe: 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.
Outcome measures
| Measure |
PTSD Wavelength-1 Bright Light
n=40 Participants
30 minutes of daily light exposure for 6 weeks
PTSD wavelength-1 bright light: 6 weeks of daily light exposure, 30 minutes per morning.
|
PTSD Wavelength-2 Bright Light
n=44 Participants
30 minutes of daily light exposure for 6 weeks
PTSD wavelength-2 bright light: 6 weeks daily light exposure, 30 minutes per morning.
|
|---|---|---|
|
Neural Activation During Functional Magnetic Resonance Imaging (fMRI) Emotion Processing Task
Baseline
|
0.0158 Arbitrary units
Standard Error 0.0213
|
-0.0843 Arbitrary units
Standard Error 0.0248
|
|
Neural Activation During Functional Magnetic Resonance Imaging (fMRI) Emotion Processing Task
Post-Treatment
|
0.0445 Arbitrary units
Standard Error 0.0242
|
0.0857 Arbitrary units
Standard Error 0.0234
|
PRIMARY outcome
Timeframe: 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).
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.
Outcome measures
| Measure |
PTSD Wavelength-1 Bright Light
n=40 Participants
30 minutes of daily light exposure for 6 weeks
PTSD wavelength-1 bright light: 6 weeks of daily light exposure, 30 minutes per morning.
|
PTSD Wavelength-2 Bright Light
n=44 Participants
30 minutes of daily light exposure for 6 weeks
PTSD wavelength-2 bright light: 6 weeks daily light exposure, 30 minutes per morning.
|
|---|---|---|
|
Performance on Neuropsychological Assessment
Baseline
|
89.95 Points
Standard Deviation 12.46
|
93.16 Points
Standard Deviation 12.46
|
|
Performance on Neuropsychological Assessment
Post-Treatment
|
91.40 Points
Standard Deviation 13.40
|
95.42 Points
Standard Deviation 14.30
|
PRIMARY outcome
Timeframe: 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.
Outcome measures
| Measure |
PTSD Wavelength-1 Bright Light
n=40 Participants
30 minutes of daily light exposure for 6 weeks
PTSD wavelength-1 bright light: 6 weeks of daily light exposure, 30 minutes per morning.
|
PTSD Wavelength-2 Bright Light
n=44 Participants
30 minutes of daily light exposure for 6 weeks
PTSD wavelength-2 bright light: 6 weeks daily light exposure, 30 minutes per morning.
|
|---|---|---|
|
PTSD Symptoms
Baseline
|
12.58 score on a scale
Standard Deviation 3.5
|
13 score on a scale
Standard Deviation 2.91
|
|
PTSD Symptoms
Post Treatment
|
7.84 score on a scale
Standard Deviation 4.40
|
9.02 score on a scale
Standard Deviation 4.55
|
PRIMARY outcome
Timeframe: Performance results at 6 weeks post-treatmentPopulation: 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).
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.
Outcome measures
| Measure |
PTSD Wavelength-1 Bright Light
n=40 Participants
30 minutes of daily light exposure for 6 weeks
PTSD wavelength-1 bright light: 6 weeks of daily light exposure, 30 minutes per morning.
|
PTSD Wavelength-2 Bright Light
n=44 Participants
30 minutes of daily light exposure for 6 weeks
PTSD wavelength-2 bright light: 6 weeks daily light exposure, 30 minutes per morning.
|
|---|---|---|
|
Daytime Sleepiness (ESS)
Baseline
|
9.93 score on a scale
Standard Deviation 4.46
|
9.61 score on a scale
Standard Deviation 4.05
|
|
Daytime Sleepiness (ESS)
Post-Treatment
|
8.82 score on a scale
Standard Deviation 4.13
|
8.82 score on a scale
Standard Deviation 3.77
|
PRIMARY outcome
Timeframe: 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.
Outcome measures
| Measure |
PTSD Wavelength-1 Bright Light
n=40 Participants
30 minutes of daily light exposure for 6 weeks
PTSD wavelength-1 bright light: 6 weeks of daily light exposure, 30 minutes per morning.
|
PTSD Wavelength-2 Bright Light
n=44 Participants
30 minutes of daily light exposure for 6 weeks
PTSD wavelength-2 bright light: 6 weeks daily light exposure, 30 minutes per morning.
|
|---|---|---|
|
Daytime Sleepiness (SSS)
Baseline - Administration 1
|
3.57 units on a scale
Standard Deviation 1.48
|
3.80 units on a scale
Standard Deviation 1.32
|
|
Daytime Sleepiness (SSS)
Baseline - Administration 2
|
3.60 units on a scale
Standard Deviation 1.38
|
3.75 units on a scale
Standard Deviation 1.31
|
|
Daytime Sleepiness (SSS)
Baseline - Administration 3
|
3.38 units on a scale
Standard Deviation 1.409
|
3.30 units on a scale
Standard Deviation 1.13
|
|
Daytime Sleepiness (SSS)
Post-Treatment - Administration 1
|
3.47 units on a scale
Standard Deviation 1.34
|
3.49 units on a scale
Standard Deviation 1.39
|
|
Daytime Sleepiness (SSS)
Post-Treatment - Administration 2
|
3.79 units on a scale
Standard Deviation 1.30
|
3.35 units on a scale
Standard Deviation 1.93
|
|
Daytime Sleepiness (SSS)
Post-Treatment - Administration 3
|
3 units on a scale
Standard Deviation 1.13
|
2.93 units on a scale
Standard Deviation 1.26
|
PRIMARY outcome
Timeframe: 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.
Outcome measures
| Measure |
PTSD Wavelength-1 Bright Light
n=38 Participants
30 minutes of daily light exposure for 6 weeks
PTSD wavelength-1 bright light: 6 weeks of daily light exposure, 30 minutes per morning.
|
PTSD Wavelength-2 Bright Light
n=43 Participants
30 minutes of daily light exposure for 6 weeks
PTSD wavelength-2 bright light: 6 weeks daily light exposure, 30 minutes per morning.
|
|---|---|---|
|
Daytime Sleepiness (MSLT)
Mean Sleep Latency in Seconds For First Administered Nap at Baseline Visit
|
486.84 seconds
Standard Deviation 359.27
|
487.67 seconds
Standard Deviation 365.97
|
|
Daytime Sleepiness (MSLT)
Mean Sleep Latency in Seconds For Second Administered Nap at Baseline Visit
|
334.05 seconds
Standard Deviation 271.12
|
390 seconds
Standard Deviation 347.79
|
|
Daytime Sleepiness (MSLT)
Mean Sleep Latency in Seconds For Third Administered Nap at Baseline Visit
|
489.20 seconds
Standard Deviation 411.4
|
520.71 seconds
Standard Deviation 408.65
|
|
Daytime Sleepiness (MSLT)
Mean Sleep Latency in Seconds For First Administered Nap while receiving Bright Light
|
597.63 seconds
Standard Deviation 459.83
|
552.75 seconds
Standard Deviation 420.65
|
|
Daytime Sleepiness (MSLT)
Mean Sleep Latency in Seconds For Second Administered Nap while receiving Bright Light
|
481.67 seconds
Standard Deviation 400.82
|
454.74 seconds
Standard Deviation 405.23
|
|
Daytime Sleepiness (MSLT)
Mean Sleep Latency in Seconds For Third Administered Nap while receiving Bright Light
|
630.00 seconds
Standard Deviation 498.96
|
494.62 seconds
Standard Deviation 382.76
|
Adverse Events
PTSD Wavelength-1 Amber
PTSD Wavelength-2 Blue
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. William D. "Scott" Killgore
University of Arizona
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place