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A Non-Pharmacological Method for Enhancing Sleep in PTSD

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ClinicalTrials.gov Identifier: NCT02370173
Recruitment Status : Recruiting
First Posted : February 24, 2015
Last Update Posted : October 8, 2019
Sponsor:
Collaborator:
U.S. Army Medical Research Acquisition Activity
Information provided by (Responsible Party):
William D. Killgore, University of Arizona

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.


Condition or disease Intervention/treatment Phase
PTSD Sleep Problems Device: PTSD wavelength-1 bright light Device: PTSD wavelength-2 bright light Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Non-Pharmacological Method for Enhancing Sleep in PTSD
Study Start Date : September 2014
Estimated Primary Completion Date : September 2020
Estimated Study Completion Date : December 2020

Arm Intervention/treatment
Experimental: PTSD wavelength-1 bright light
30 minutes of daily light exposure for 6 weeks
Device: PTSD wavelength-1 bright light
6 weeks of daily light exposure, 30 minutes per morning.

Placebo Comparator: PTSD wavelength-2 bright light
30 minutes of daily light exposure for 6 weeks
Device: PTSD wavelength-2 bright light
6 weeks daily light exposure, 30 minutes per morning.




Primary Outcome Measures :
  1. Sleep Quality [ Time Frame: Change from baseline at 6 weeks (post-treatment) ]
    The Subjective Measure: Pittsburgh Sleep Quality Index and Objective measure: Actigraphy, will be used to assess average sleep quality.

  2. Neural activation during functional magnetic resonance imaging (fMRI) executive function task [ Time Frame: Change from baseline performance at 6 weeks (post-treatment) ]
  3. Performance on neuropsychological assessment [ Time Frame: Change from baseline performance at 6 weeks (post-treatment) ]
    The Automated Neuropsychiatric Assessment Metrics and the Repeatable Battery for the Assessment of Neuropsychological Status will be utilized to measure overall neurocognitive performance.

  4. PTSD Symptoms [ Time Frame: Change from baseline performance at 6 weeks (post-treatment) ]
    The PTSD Checklist will be used to measure PTSD symptoms.

  5. Daytime Sleepiness [ Time Frame: Change from baseline performance at 6 weeks (post-treatment) ]
    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.



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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02370173


Contacts
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Contact: Meltem Ozcan 520-626-8591 mozcan@psychiatry.arizona.edu
Contact: Caleigh Shepard kcshepard@psychiatry.arizona.edu

Locations
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United States, Arizona
University of Arizona Recruiting
Tucson, Arizona, United States, 85724
Contact: Meltem Ozcan       mozcan@psychiatry.arizona.edu   
Principal Investigator: William Killgore, Ph.D.         
Sponsors and Collaborators
University of Arizona
U.S. Army Medical Research Acquisition Activity
Investigators
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Principal Investigator: William Killgore, Ph.D. University of Arizona

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Responsible Party: William D. Killgore, Principal Investigator, University of Arizona
ClinicalTrials.gov Identifier: NCT02370173     History of Changes
Other Study ID Numbers: 1407389306A003
First Posted: February 24, 2015    Key Record Dates
Last Update Posted: October 8, 2019
Last Verified: October 2019
Keywords provided by William D. Killgore, University of Arizona:
PTSD
Stress
Sleep Problems
Brain imaging
fMRI
Additional relevant MeSH terms:
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Dyssomnias
Sleep Wake Disorders
Parasomnias
Mental Disorders
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms