Tucson, Arizona 85724


Purpose:

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.


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.


Study is Available At:


Original ID:

1407389306A003


NCT ID:

NCT02370173


Secondary ID:


Study Acronym:


Brief Title:

A Non-Pharmacological Method for Enhancing Sleep in PTSD


Official Title:

A Non-Pharmacological Method for Enhancing Sleep in PTSD


Overall Status:

Recruiting


Study Phase:

N/A


Genders:

N/A


Minimum Age:

18 Years


Maximum Age:

50 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

University of Arizona


Oversight Authority:

United States: Institutional Review Board


Reasons Why Stopped:


Study Type:

Interventional


Study Design:


Number of Arms:

2


Number of Groups:

0


Total Enrollment:

90


Enrollment Type:

Anticipated


Overall Contact Information

Official Name:William Killgore, Ph.D.
Principal Investigator
University of Arizona
Primary Contact:Meltem Ozcan
520-626-8591
mozcan@psychiatry.arizona.edu
Backup Contact:Caleigh Shepard
kcshepard@psychiatry.arizona.edu

Study Dates

Start Date:September 2014
Completion Date:December 2020
Completion Type:Anticipated
Primary Completion Date:September 2020
Primary Completion Type:Anticipated
Verification Date:October 2019
Last Changed Date:October 7, 2019
First Received Date:October 15, 2014

Study Outcomes

Outcome Type:Primary Outcome
Measure:Sleep Quality
Time Frame:Change from baseline at 6 weeks (post-treatment)
Safety Issues:False
Description:The Subjective Measure: Pittsburgh Sleep Quality Index and Objective measure: Actigraphy, will be used to assess average sleep quality.
Outcome Type:Primary Outcome
Measure:Neural activation during functional magnetic resonance imaging (fMRI) executive function task
Time Frame:Change from baseline performance at 6 weeks (post-treatment)
Safety Issues:False
Outcome Type:Primary Outcome
Measure:Performance on neuropsychological assessment
Time Frame:Change from baseline performance at 6 weeks (post-treatment)
Safety Issues:False
Description:The Automated Neuropsychiatric Assessment Metrics and the Repeatable Battery for the Assessment of Neuropsychological Status will be utilized to measure overall neurocognitive performance.
Outcome Type:Primary Outcome
Measure:PTSD Symptoms
Time Frame:Change from baseline performance at 6 weeks (post-treatment)
Safety Issues:False
Description:The PTSD Checklist will be used to measure PTSD symptoms.
Outcome Type:Primary Outcome
Measure:Daytime Sleepiness
Time Frame:Change from baseline performance at 6 weeks (post-treatment)
Safety Issues:False
Description:Subjective measures: Epworth Sleepiness Scale, and Stanford sleepiness Scale, and the Objective measure: Multiple Sleep Latency Test (MSLT) will be used to assess daytime sleepiness.

Study Interventions

Intervention Type:Device
Name:PTSD wavelength-1 bright light
Description:6 weeks of daily light exposure, 30 minutes per morning.
Arm Name:PTSD wavelength-1 bright light
Intervention Type:Device
Name:PTSD wavelength-2 bright light
Description:6 weeks daily light exposure, 30 minutes per morning.
Arm Name:PTSD wavelength-2 bright light

Study Arms

Study Arm Type:Placebo Comparator
Arm Name:PTSD wavelength-2 bright light
Description:30 minutes of daily light exposure for 6 weeks
Study Arm Type:Experimental
Arm Name:PTSD wavelength-1 bright light
Description:30 minutes of daily light exposure for 6 weeks

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:University of Arizona
Agency Class:U.S. Fed
Agency Type:Collaborator
Agency Name:U.S. Army Medical Research Acquisition Activity

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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