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A Non-Pharmacological Method for Enhancing Sleep in PTSD

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University of Arizona

Status

Completed

Conditions

PTSD
Sleep Problems

Treatments

Device: PTSD wavelength-1 bright light
Device: PTSD wavelength-2 bright light

Study type

Interventional

Funder types

Other
Other U.S. Federal agency

Identifiers

NCT02370173
1407389306A003

Details and patient eligibility

About

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.

Enrollment

90 patients

Sex

All

Ages

18 to 50 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

90 participants in 2 patient groups, including a placebo group

PTSD wavelength-1 bright light
Experimental group
Description:
30 minutes of daily light exposure for 6 weeks
Treatment:
Device: PTSD wavelength-1 bright light
PTSD wavelength-2 bright light
Placebo Comparator group
Description:
30 minutes of daily light exposure for 6 weeks
Treatment:
Device: PTSD wavelength-2 bright light

Trial documents
1

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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