Improving Sleep in Veterans With TBI



Status:Not yet recruiting
Conditions:Neurology
Therapuetic Areas:Neurology
Healthy:No
Age Range:18 - 70
Updated:1/3/2019
Start Date:May 1, 2019
End Date:December 31, 2023
Contact:Sharon D Jacky, PHR
Email:Sharon.Jacky@va.gov
Phone:(503) 220-8262

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A Sleep Intervention to Improve Rehabilitation in Veterans With Chronic mTBI

Traumatic brain injury (TBI) is a major cause of disability in the Veteran population, often
resulting in chronic pain and sleep disturbances, among other issues. Extensive
rehabilitative efforts are usually required and often prevent return to the workforce and
community. Disturbed sleep and excessive daytime sleepiness are among the most pervasive and
enduring problems after TBI, which the investigators hypothesize is a significant contributor
to these functional impairments and an impediment toward rehabilitation. Thus, this research
aims to enhance sleep quality as a means to reduce pain and improve quality of life and
functional outcome measures in Veterans with TBI. The investigators predict that the proposed
intervention, morning bright light therapy, if found effective, will be cost-effective,
rapidly deployable, and highly accepted by Veterans with TBI.

Each year ~2.5 million people sustain a traumatic brain injury (TBI). Also a prominent
general public health issue, TBI is particularly prevalent in Veterans, with 60-80% reporting
a history of TBI. Over 80% of all TBI are categorized as mild TBI (mTBI), which is associated
with a myriad of short- and long-term complications. Two of the principal complicating
factors associated with mTBI are sleep-wake disturbances (e.g., insomnia, excessive daytime
sleepiness, and circadian rhythm sleep disorders) and chronic pain, including headache and
diffuse/global pain. Sleep-wake disturbances and chronic pain have an independent prevalence
of ~70%, individually impair quality of life, impede effective rehabilitative therapies, and
have staggering functional and economic impacts.

Furthermore, there is a strong bidirectional relationship between sleep-wake disturbances and
pain such that impaired sleep exacerbates pain, which leads to greater impairments in sleep
and worse pain. This vicious cycle between sleep disturbances and pain, which is a
particularly prevalent and detrimental condition in Veterans with chronic mTBI, represents a
central challenge precluding effective treatment and ultimately, improving Veteran quality of
life. Although there are pharmacological and non-pharmacological therapies for chronic pain,
the presence of TBI significantly complicates the effectiveness of these treatment options,
and have significant adverse effects (e.g., long-term prescription opioid dependence, misuse,
or overdose). The investigators believe there is profound potential to intervene at the sleep
level, and, by improving sleep quality, enable Veterans with chronic mTBI to better manage
their pain and end this vicious cycle.

This proposal aims to apply a sleep intervention to improve chronic pain in Veterans with
mTBI. The investigators propose to use morning bright light therapy (MBLT), a readily
deployable, cost-effective, non-pharmacologic, and home-based sleep intervention, to improve
sleep-wake disturbances and therefore ameliorate chronic pain and improve quality of life in
Veterans with chronic mTBI. Outcomes will be assessed pre- and post-intervention, and at a
3-month follow-up time point. The central hypothesis is that MBLT will improve sleep quality
and ameliorate pain, resulting in improved quality of life in Veterans with chronic mTBI.

Inclusion Criteria:

- Veteran

- Medical record-confirmed diagnosis of mTBI

- Current self-reported sleep-wake disturbances

- defined by clinically abnormal Insomnia Severity Index and/or Functional Outcomes
of Sleep scores

- Moderate to severe pain

- defined as a score of 4 on an 11-point scale94) persisting for longer than 6
months

- English speaking with phone access

Exclusion Criteria:

Exclusion Criteria:

- Decisional impairment and/or dementia

- Current usage of a lightbox or negative ion generator

- Shift work

- History of macular degeneration and/or bipolar disorder

- Evidence for suicidal ideation

- Cancer diagnosis within the past 6 months

- Surgery within the past 6-12 months

- Substance abuse within the past 6-12 months
We found this trial at
1
site
Portland, Oregon 97201
Principal Investigator: Jonathan E Elliott, PhD
Phone: 503-220-8262
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mi
from
Portland, OR
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