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Improving Sleep in Veterans With TBI (SPTBI)

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ClinicalTrials.gov Identifier: NCT03785600
Recruitment Status : Not yet recruiting
First Posted : December 24, 2018
Last Update Posted : January 1, 2019
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Traumatic Brain Injury Device: Morning Bright Light Therapy Device: Negative Ion Generator Not Applicable

Detailed Description:

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Subjects will be randomized to receive MBLT or a sham/no-light control. Subjects randomized to receive MBLT will be given a light box (LightPad, Aurora Light Solutions) to take home. Subjects randomized to receive the sham/no-light control will be given a negative ion generator that has been deactivated such that it still emits an audible hum but does not emit ions.
Masking: Single (Participant)
Masking Description: Participants will be blinded to the intervention by way of study personnel's description. Subjects will be told that both devices may or may not be active and thus, will be unaware that all light boxes are active and all negative ion generators are inactivated.
Primary Purpose: Supportive Care
Official Title: A Sleep Intervention to Improve Rehabilitation in Veterans With Chronic mTBI
Estimated Study Start Date : May 1, 2019
Estimated Primary Completion Date : December 31, 2021
Estimated Study Completion Date : December 31, 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Morning Bright Light Therapy
Morning bright light therapy for 30-60 minutes every morning within 90 minutes of waking up. The light box should be positioned no more than 24 inches away.
Device: Morning Bright Light Therapy
Morning bright light therapy for 30-60 minutes every morning within 90 minutes of waking up. The light box should be positioned no more than 24 inches away.
Other Name: Lightbox, light therapy

Sham Comparator: Negative Ion Generator
Negative ion generators will be deactivated such that they no longer produce ions but still emit an audible hum that gives the perception of functioning. Subjects will sit in front of this device for 30-60 minutes every morning within 90 minutes of waking up.
Device: Negative Ion Generator
Negative ion generators will be deactivated such that they no longer produce ions but still emit an audible hum that gives the perception of functioning. Subjects will sit in front of this device for 30-60 minutes every morning within 90 minutes of waking up.




Primary Outcome Measures :
  1. self-reported sleep quality change determined via the insomnia severity index [ Time Frame: Pre- and post-4 weeks of MBLT or sham treatment, and 12 weeks following the end of MBLT or sham treatment ]
    Insomnia severity index 7 questions; each question is a 0-4 scale, total score range is 0-28 Higher scores represent worse outcomes

  2. self-reported pain change determined via the NIH PROMIS scale [ Time Frame: Pre- and post-4 weeks of MBLT or sham treatment, and 12 weeks following the end of MBLT or sham treatment ]
    NIH PROMIS Pain Scale 4 questions; each question is a 0-4 scale, total score range is 0-16 Higher scores represent worse outcomes

  3. self-reported quality of life change determined via the WHO-DAS 2.0 [ Time Frame: Pre- and post-4 weeks of MBLT or sham treatment, and 12 weeks following the end of MBLT or sham treatment ]
    World Health Organization Disability Assessment Schedule 2.0 12 questions; each question is a 0-4 scale, total score range is 0-48 Higher scores represent worse outcomes



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03785600


Contacts
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Contact: Sharon D Jacky, PHR (503) 220-8262 ext 58346 Sharon.Jacky@va.gov
Contact: Archie (Herman) G Bouwer, PhD (503) 220-8262 ext 52900 Archie.Bouwer@va.gov

Locations
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United States, Oregon
VA Portland Health Care System, Portland, OR Not yet recruiting
Portland, Oregon, United States, 97239
Contact: Sharon D Jacky, PHR    503-220-8262 ext 58346    Sharon.Jacky@va.gov   
Principal Investigator: Jonathan E Elliott, PhD         
Sponsors and Collaborators
VA Office of Research and Development
Investigators
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Principal Investigator: Jonathan E Elliott, PhD VA Portland Health Care System, Portland, OR

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Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT03785600     History of Changes
Other Study ID Numbers: D2947-W
IK2RX002947 ( Other Grant/Funding Number: VA )
First Posted: December 24, 2018    Key Record Dates
Last Update Posted: January 1, 2019
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by VA Office of Research and Development:
traumatic brain injury
sleep-wake disturbances
Veterans
chronic pain

Additional relevant MeSH terms:
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Brain Injuries
Brain Injuries, Traumatic
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System
Wounds and Injuries