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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 : July 30, 2019
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development

Tracking Information
First Submitted Date  ICMJE December 20, 2018
First Posted Date  ICMJE December 24, 2018
Last Update Posted Date July 30, 2019
Estimated Study Start Date  ICMJE November 1, 2019
Estimated Primary Completion Date December 31, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 26, 2019)
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
Original Primary Outcome Measures  ICMJE
 (submitted: December 20, 2018)
  • 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
  • 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
  • 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
Change History Complete list of historical versions of study NCT03785600 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Improving Sleep in Veterans With TBI
Official Title  ICMJE A Sleep Intervention to Improve Rehabilitation in Veterans With Chronic mTBI
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.
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE 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 modified negative ion generator.
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
Condition  ICMJE Traumatic Brain Injury
Intervention  ICMJE
  • Device: Morning Bright Light Therapy
    Morning bright light: Sitting in front of a lightbox for 60 minutes every morning within 90 minutes of waking up.
    Other Name: Lightbox, light therapy
  • Device: Negative Ion Generator
    Negative ion generator: Sitting in front of a modified negative ion generator for 60 min every morning within 90 minutes of waking up.
Study Arms  ICMJE
  • Experimental: Morning Bright Light Therapy
    Morning bright light: Sitting in front of a lightbox for 60 minutes every morning within 90 minutes of waking up.
    Intervention: Device: Morning Bright Light Therapy
  • Sham Comparator: Negative Ion Generator
    Negative ion generator: Sitting in front of a modified negative ion generator for 60 min every morning within 90 minutes of waking up.
    Intervention: Device: Negative Ion Generator
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: December 20, 2018)
100
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE April 30, 2023
Estimated Primary Completion Date December 31, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
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
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03785600
Other Study ID Numbers  ICMJE D2947-W
IK2RX002947 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party VA Office of Research and Development
Study Sponsor  ICMJE VA Office of Research and Development
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Jonathan E Elliott, PhD VA Portland Health Care System, Portland, OR
PRS Account VA Office of Research and Development
Verification Date July 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP