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N/A N=90 Randomized Double-blind Treatment

A Non-Pharmacological Method for Enhancing Sleep in PTSD

PTSD · Sleep Problems

Enrolled (actual)
90
Serious AEs
0.0%
Results posted
Jun 2023
Primary outcome: Primary: Sleep Efficiency — 88.13; 89.95; 89.31; 89.20 Percentage of Sleep

Study Design & Population

Study type
Interventional
Phase
N/A
Interventions
PTSD wavelength-1 bright light (Device); PTSD wavelength-2 bright light (Device)
Age
Adult · 18+ yrs
Sex
All
Sponsor
University of Arizona
Primary completion
Apr 2020

Outcome Measures

OutcomeResultp-value
PRIMARY
Sleep Efficiency
88.13; 89.95; 89.31; 89.20
PRIMARY
Subjective Sleep Quality
9.08; 9.86; 7.53; 8.34
PRIMARY
Neural Activation During Functional Magnetic Resonance Imaging (fMRI) Emotion Processing Task
0.0158; -0.0843; 0.0445; 0.0857
PRIMARY
Performance on Neuropsychological Assessment
89.95; 93.16; 91.40; 95.42
PRIMARY
PTSD Symptoms
12.58; 13; 7.84; 9.02
PRIMARY
Daytime Sleepiness (ESS)
9.93; 9.61; 8.82; 8.82
PRIMARY
Daytime Sleepiness (SSS)
3.57; 3.80; 3.60; 3.75; 3.38; 3.30
PRIMARY
Daytime Sleepiness (MSLT)
486.84; 487.67; 334.05; 390; 489.20; 520.71

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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02370173). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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