Clinical trial NCT02370173: A Non-Pharmacological Method for Enhancing Sleep in PTSD
Official title: A Non-Pharmacological Method for Enhancing Sleep in PTSD
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: PTSD
Sleep Problems
Keywords: PTSD
Stress
Sleep Problems
Brain imaging
fMRI
Lead sponsor: University of Arizona
Sponsor class: OTHER
Collaborators: name: U.S. Army Medical Research Acquisition Activity
First posted: 2015-02-24
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Sleep Efficiency
timeFrame: Sleep Efficiency was calculated at Baseline (Pre-Treatment) and Post-Treatment (6 Weeks after Baseline)
measure: Subjective Sleep Quality
timeFrame: Results 6 weeks post-treatment
measure: Neural Activation During Functional Magnetic Resonance Imaging (fMRI) Emotion Processing Task
timeFrame: Baseline (Pre-Treatment) and Post-Treatment (6 Weeks after Baseline)
measure: Performance on Neuropsychological Assessment
timeFrame: Performance results at 6 weeks post-treatment.
measure: PTSD Symptoms
timeFrame: Performance results at 6 weeks post-treatment.
measure: Daytime Sleepiness (ESS)
timeFrame: Performance results at 6 weeks post-treatment
measure: Daytime Sleepiness (SSS)
timeFrame: Performance results at 6 weeks post-treatment.
measure: Daytime Sleepiness (MSLT)
timeFrame: Change from baseline performance at 6 weeks (post-treatment)
Secondary outcomes:
Other outcomes:
Locations:
city: Tucson
country: United States
facility: University of Arizona Psychiatry Department
state: Arizona
Study officials:
affiliation: University of Arizona
name: William Killgore, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: