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A Non-Pharmacological Method for Enhancing Sleep in PTSD

A Non-Pharmacological Method for Enhancing Sleep in PTSD

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02370173
Enrollment
90
Registered
2015-02-24
Start date
2014-09-30
Completion date
2020-04-30
Last updated
2023-06-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

PTSD, Sleep Problems

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

DEVICEPTSD wavelength-1 bright light

6 weeks of daily light exposure, 30 minutes per morning.

DEVICEPTSD wavelength-2 bright light

6 weeks daily light exposure, 30 minutes per morning.

Sponsors

U.S. Army Medical Research Acquisition Activity
CollaboratorFED
University of Arizona
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
No

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

MeasureTime frameDescription
Sleep EfficiencySleep 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 QualityResults 6 weeks post-treatmentPittsburgh 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 TaskBaseline (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 AssessmentPerformance 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 SymptomsPerformance 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-treatmentEpworth 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

ArmCount
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
Total90

Withdrawals & dropouts

PeriodReasonFG000FG001
Overall StudyProtocol Violation11
Overall StudyWithdrawal by Subject22

Baseline characteristics

CharacteristicPTSD Wavelength-2 BlueTotalPTSD Wavelength-1 Amber
Age, Categorical
<=18 years
0 Participants0 Participants0 Participants
Age, Categorical
>=65 years
0 Participants0 Participants0 Participants
Age, Categorical
Between 18 and 65 years
47 Participants90 Participants43 Participants
Age, Continuous32.02 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 Participants1 Participants0 Participants
Race/Ethnicity, Customized
Black/African American
2 Participants4 Participants2 Participants
Race/Ethnicity, Customized
Hispanic/Latino
9 Participants17 Participants8 Participants
Race/Ethnicity, Customized
Native American/American Indian
0 Participants3 Participants3 Participants
Race/Ethnicity, Customized
Other
4 Participants6 Participants2 Participants
Race/Ethnicity, Customized
White
31 Participants59 Participants28 Participants
Region of Enrollment
United States
47 participants90 participants43 participants
Sex: Female, Male
Female
16 Participants30 Participants14 Participants
Sex: Female, Male
Male
31 Participants60 Participants29 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 430 / 47
other
Total, other adverse events
0 / 430 / 47
serious
Total, serious adverse events
0 / 430 / 47

Outcome results

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.

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).

ArmMeasureGroupValue (MEAN)Dispersion
PTSD Wavelength-1 Bright LightDaytime Sleepiness (ESS)Baseline9.93 score on a scaleStandard Deviation 4.46
PTSD Wavelength-1 Bright LightDaytime Sleepiness (ESS)Post-Treatment8.82 score on a scaleStandard Deviation 4.13
PTSD Wavelength-2 Bright LightDaytime Sleepiness (ESS)Baseline9.61 score on a scaleStandard Deviation 4.05
PTSD Wavelength-2 Bright LightDaytime Sleepiness (ESS)Post-Treatment8.82 score on a scaleStandard Deviation 3.77
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.

Time frame: Change from baseline performance at 6 weeks (post-treatment)

ArmMeasureGroupValue (MEAN)Dispersion
PTSD Wavelength-1 Bright LightDaytime Sleepiness (MSLT)Mean Sleep Latency in Seconds For First Administered Nap at Baseline Visit486.84 secondsStandard Deviation 359.27
PTSD Wavelength-1 Bright LightDaytime Sleepiness (MSLT)Mean Sleep Latency in Seconds For Second Administered Nap at Baseline Visit334.05 secondsStandard Deviation 271.12
PTSD Wavelength-1 Bright LightDaytime Sleepiness (MSLT)Mean Sleep Latency in Seconds For Third Administered Nap at Baseline Visit489.20 secondsStandard Deviation 411.4
PTSD Wavelength-1 Bright LightDaytime Sleepiness (MSLT)Mean Sleep Latency in Seconds For First Administered Nap while receiving Bright Light597.63 secondsStandard Deviation 459.83
PTSD Wavelength-1 Bright LightDaytime Sleepiness (MSLT)Mean Sleep Latency in Seconds For Second Administered Nap while receiving Bright Light481.67 secondsStandard Deviation 400.82
PTSD Wavelength-1 Bright LightDaytime Sleepiness (MSLT)Mean Sleep Latency in Seconds For Third Administered Nap while receiving Bright Light630.00 secondsStandard Deviation 498.96
PTSD Wavelength-2 Bright LightDaytime Sleepiness (MSLT)Mean Sleep Latency in Seconds For Second Administered Nap while receiving Bright Light454.74 secondsStandard Deviation 405.23
PTSD Wavelength-2 Bright LightDaytime Sleepiness (MSLT)Mean Sleep Latency in Seconds For First Administered Nap at Baseline Visit487.67 secondsStandard Deviation 365.97
PTSD Wavelength-2 Bright LightDaytime Sleepiness (MSLT)Mean Sleep Latency in Seconds For First Administered Nap while receiving Bright Light552.75 secondsStandard Deviation 420.65
PTSD Wavelength-2 Bright LightDaytime Sleepiness (MSLT)Mean Sleep Latency in Seconds For Second Administered Nap at Baseline Visit390 secondsStandard Deviation 347.79
PTSD Wavelength-2 Bright LightDaytime Sleepiness (MSLT)Mean Sleep Latency in Seconds For Third Administered Nap while receiving Bright Light494.62 secondsStandard Deviation 382.76
PTSD Wavelength-2 Bright LightDaytime Sleepiness (MSLT)Mean Sleep Latency in Seconds For Third Administered Nap at Baseline Visit520.71 secondsStandard Deviation 408.65
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.

Time frame: Performance results at 6 weeks post-treatment.

ArmMeasureGroupValue (MEAN)Dispersion
PTSD Wavelength-1 Bright LightDaytime Sleepiness (SSS)Baseline - Administration 13.57 units on a scaleStandard Deviation 1.48
PTSD Wavelength-1 Bright LightDaytime Sleepiness (SSS)Baseline - Administration 23.60 units on a scaleStandard Deviation 1.38
PTSD Wavelength-1 Bright LightDaytime Sleepiness (SSS)Baseline - Administration 33.38 units on a scaleStandard Deviation 1.409
PTSD Wavelength-1 Bright LightDaytime Sleepiness (SSS)Post-Treatment - Administration 13.47 units on a scaleStandard Deviation 1.34
PTSD Wavelength-1 Bright LightDaytime Sleepiness (SSS)Post-Treatment - Administration 23.79 units on a scaleStandard Deviation 1.3
PTSD Wavelength-1 Bright LightDaytime Sleepiness (SSS)Post-Treatment - Administration 33 units on a scaleStandard Deviation 1.13
PTSD Wavelength-2 Bright LightDaytime Sleepiness (SSS)Post-Treatment - Administration 23.35 units on a scaleStandard Deviation 1.93
PTSD Wavelength-2 Bright LightDaytime Sleepiness (SSS)Baseline - Administration 13.80 units on a scaleStandard Deviation 1.32
PTSD Wavelength-2 Bright LightDaytime Sleepiness (SSS)Post-Treatment - Administration 13.49 units on a scaleStandard Deviation 1.39
PTSD Wavelength-2 Bright LightDaytime Sleepiness (SSS)Baseline - Administration 23.75 units on a scaleStandard Deviation 1.31
PTSD Wavelength-2 Bright LightDaytime Sleepiness (SSS)Post-Treatment - Administration 32.93 units on a scaleStandard Deviation 1.26
PTSD Wavelength-2 Bright LightDaytime Sleepiness (SSS)Baseline - Administration 33.30 units on a scaleStandard Deviation 1.13
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.

Time frame: Baseline (Pre-Treatment) and Post-Treatment (6 Weeks after Baseline)

ArmMeasureGroupValue (MEAN)Dispersion
PTSD Wavelength-1 Bright LightNeural Activation During Functional Magnetic Resonance Imaging (fMRI) Emotion Processing TaskPost-Treatment0.0445 Arbitrary unitsStandard Error 0.0242
PTSD Wavelength-1 Bright LightNeural Activation During Functional Magnetic Resonance Imaging (fMRI) Emotion Processing TaskBaseline0.0158 Arbitrary unitsStandard Error 0.0213
PTSD Wavelength-2 Bright LightNeural Activation During Functional Magnetic Resonance Imaging (fMRI) Emotion Processing TaskBaseline-0.0843 Arbitrary unitsStandard Error 0.0248
PTSD Wavelength-2 Bright LightNeural Activation During Functional Magnetic Resonance Imaging (fMRI) Emotion Processing TaskPost-Treatment0.0857 Arbitrary unitsStandard Error 0.0234
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.

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).

ArmMeasureGroupValue (MEAN)Dispersion
PTSD Wavelength-1 Bright LightPerformance on Neuropsychological AssessmentBaseline89.95 PointsStandard Deviation 12.46
PTSD Wavelength-1 Bright LightPerformance on Neuropsychological AssessmentPost-Treatment91.40 PointsStandard Deviation 13.4
PTSD Wavelength-2 Bright LightPerformance on Neuropsychological AssessmentBaseline93.16 PointsStandard Deviation 12.46
PTSD Wavelength-2 Bright LightPerformance on Neuropsychological AssessmentPost-Treatment95.42 PointsStandard Deviation 14.3
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.

Time frame: Performance results at 6 weeks post-treatment.

ArmMeasureGroupValue (MEAN)Dispersion
PTSD Wavelength-1 Bright LightPTSD SymptomsPost Treatment7.84 score on a scaleStandard Deviation 4.4
PTSD Wavelength-1 Bright LightPTSD SymptomsBaseline12.58 score on a scaleStandard Deviation 3.5
PTSD Wavelength-2 Bright LightPTSD SymptomsBaseline13 score on a scaleStandard Deviation 2.91
PTSD Wavelength-2 Bright LightPTSD SymptomsPost Treatment9.02 score on a scaleStandard Deviation 4.55
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.

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).

ArmMeasureGroupValue (MEAN)Dispersion
PTSD Wavelength-1 Bright LightSleep EfficiencyBaseline88.13 Percentage of SleepStandard Deviation 3.96
PTSD Wavelength-1 Bright LightSleep EfficiencyPost-Treatment89.31 Percentage of SleepStandard Deviation 3.58
PTSD Wavelength-2 Bright LightSleep EfficiencyBaseline89.95 Percentage of SleepStandard Deviation 3.17
PTSD Wavelength-2 Bright LightSleep EfficiencyPost-Treatment89.20 Percentage of SleepStandard Deviation 4.03
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.

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).

ArmMeasureGroupValue (MEAN)Dispersion
PTSD Wavelength-1 Bright LightSubjective Sleep QualityBaseline9.08 score on a scaleStandard Deviation 3.42
PTSD Wavelength-1 Bright LightSubjective Sleep QualityPost-Treatment7.53 score on a scaleStandard Deviation 3.12
PTSD Wavelength-2 Bright LightSubjective Sleep QualityBaseline9.86 score on a scaleStandard Deviation 3.01
PTSD Wavelength-2 Bright LightSubjective Sleep QualityPost-Treatment8.34 score on a scaleStandard Deviation 3.24

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026