A Non-Pharmacological Method for Enhancing Sleep in PTSD

PTSD Clinical Trial

Official title:

A Non-Pharmacological Method for Enhancing Sleep in PTSD

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02370173
• Other study ID #: 1407389306A003
• Status: Completed
• Phase: N/A
• Start date: September 2014
• Est. completion date: April 2020

Study information

• Verified date: May 2023
• Source: University of Arizona
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: April 2020
• Est. primary completion date: April 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

• 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.

Related Conditions & MeSH terms

• Dyssomnias
• Parasomnias
• PTSD
• Sleep Problems

Intervention

Device:
• PTSD wavelength-1 bright light
6 weeks of daily light exposure, 30 minutes per morning.
• PTSD wavelength-2 bright light
6 weeks daily light exposure, 30 minutes per morning.

Locations

Country	Name	City	State
United States	University of Arizona Psychiatry Department	Tucson	Arizona

Sponsors (2)

Lead Sponsor	Collaborator
University of Arizona	U.S. Army Medical Research Acquisition Activity

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	Sleep Efficiency was calculated at Baseline (Pre-Treatment) and Post-Treatment (6 Weeks after Baseline)
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.	Results 6 weeks post-treatment
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.	Baseline (Pre-Treatment) and Post-Treatment (6 Weeks after Baseline)
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.	Performance results at 6 weeks post-treatment.
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.	Performance results at 6 weeks post-treatment.
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.	Performance results at 6 weeks post-treatment
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.	Performance results at 6 weeks post-treatment.
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.	Change from baseline performance at 6 weeks (post-treatment)