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A Non-Pharmacological Method for Enhancing Sleep in PTSD

Primary Purpose

PTSD, Sleep Problems

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
PTSD wavelength-1 bright light
PTSD wavelength-2 bright light
Sponsored by
University of Arizona
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for PTSD focused on measuring PTSD, Stress, Sleep Problems, Brain imaging, fMRI

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesDoes not accept healthy volunteers
  • 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.

Sites / Locations

  • University of Arizona Psychiatry Department

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

PTSD wavelength-1 bright light

PTSD wavelength-2 bright light

Arm Description

30 minutes of daily light exposure for 6 weeks

30 minutes of daily light exposure for 6 weeks

Outcomes

Primary Outcome Measures

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.
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.
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.
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.
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.
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.
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.
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.

Secondary Outcome Measures

Full Information

First Posted
October 15, 2014
Last Updated
May 31, 2023
Sponsor
University of Arizona
Collaborators
U.S. Army Medical Research Acquisition Activity
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1. Study Identification

Unique Protocol Identification Number
NCT02370173
Brief Title
A Non-Pharmacological Method for Enhancing Sleep in PTSD
Official Title
A Non-Pharmacological Method for Enhancing Sleep in PTSD
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
September 2014 (undefined)
Primary Completion Date
April 2020 (Actual)
Study Completion Date
April 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Arizona
Collaborators
U.S. Army Medical Research Acquisition Activity

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
PTSD, Sleep Problems
Keywords
PTSD, Stress, Sleep Problems, Brain imaging, fMRI

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
90 (Actual)

8. Arms, Groups, and Interventions

Arm Title
PTSD wavelength-1 bright light
Arm Type
Experimental
Arm Description
30 minutes of daily light exposure for 6 weeks
Arm Title
PTSD wavelength-2 bright light
Arm Type
Placebo Comparator
Arm Description
30 minutes of daily light exposure for 6 weeks
Intervention Type
Device
Intervention Name(s)
PTSD wavelength-1 bright light
Intervention Description
6 weeks of daily light exposure, 30 minutes per morning.
Intervention Type
Device
Intervention Name(s)
PTSD wavelength-2 bright light
Intervention Description
6 weeks daily light exposure, 30 minutes per morning.
Primary Outcome Measure Information:
Title
Sleep Efficiency
Description
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)
Title
Subjective Sleep Quality
Description
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
Title
Neural Activation During Functional Magnetic Resonance Imaging (fMRI) Emotion Processing Task
Description
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)
Title
Performance on Neuropsychological Assessment
Description
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.
Title
PTSD Symptoms
Description
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.
Title
Daytime Sleepiness (ESS)
Description
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
Title
Daytime Sleepiness (SSS)
Description
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.
Title
Daytime Sleepiness (MSLT)
Description
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)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
William Killgore, Ph.D.
Organizational Affiliation
University of Arizona
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Arizona Psychiatry Department
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85724
Country
United States

12. IPD Sharing Statement

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A Non-Pharmacological Method for Enhancing Sleep in PTSD

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