<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03785600</url>
  </required_header>
  <id_info>
    <org_study_id>D2947-W</org_study_id>
    <secondary_id>IK2RX002947</secondary_id>
    <nct_id>NCT03785600</nct_id>
  </id_info>
  <brief_title>Improving Sleep in Veterans With TBI</brief_title>
  <acronym>SPTBI</acronym>
  <official_title>A Sleep Intervention to Improve Rehabilitation in Veterans With Chronic mTBI</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>VA Office of Research and Development</agency>
      <agency_class>U.S. Fed</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>VA Office of Research and Development</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      Traumatic brain injury (TBI) is a major cause of disability in the Veteran population, often&#xD;
      resulting in chronic pain and sleep disturbances, among other issues. Extensive&#xD;
      rehabilitative efforts are usually required and often prevent return to the workforce and&#xD;
      community. Disturbed sleep and excessive daytime sleepiness are among the most pervasive and&#xD;
      enduring problems after TBI, which the investigators hypothesize is a significant contributor&#xD;
      to these functional impairments and an impediment toward rehabilitation. Thus, this research&#xD;
      aims to enhance sleep quality as a means to reduce pain and improve quality of life and&#xD;
      functional outcome measures in Veterans with TBI. The investigators predict that the proposed&#xD;
      intervention, morning bright light therapy, if found effective, will be cost-effective,&#xD;
      rapidly deployable, and highly accepted by Veterans with TBI.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Each year ~2.5 million people sustain a traumatic brain injury (TBI). Also a prominent&#xD;
      general public health issue, TBI is particularly prevalent in Veterans, with 60-80% reporting&#xD;
      a history of TBI. Over 80% of all TBI are categorized as mild TBI (mTBI), which is associated&#xD;
      with a myriad of short- and long-term complications. Two of the principal complicating&#xD;
      factors associated with mTBI are sleep-wake disturbances (e.g., insomnia, excessive daytime&#xD;
      sleepiness, and circadian rhythm sleep disorders) and chronic pain, including headache and&#xD;
      diffuse/global pain. Sleep-wake disturbances and chronic pain have an independent prevalence&#xD;
      of ~70%, individually impair quality of life, impede effective rehabilitative therapies, and&#xD;
      have staggering functional and economic impacts.&#xD;
&#xD;
      Furthermore, there is a strong bidirectional relationship between sleep-wake disturbances and&#xD;
      pain such that impaired sleep exacerbates pain, which leads to greater impairments in sleep&#xD;
      and worse pain. This vicious cycle between sleep disturbances and pain, which is a&#xD;
      particularly prevalent and detrimental condition in Veterans with chronic mTBI, represents a&#xD;
      central challenge precluding effective treatment and ultimately, improving Veteran quality of&#xD;
      life. Although there are pharmacological and non-pharmacological therapies for chronic pain,&#xD;
      the presence of TBI significantly complicates the effectiveness of these treatment options,&#xD;
      and have significant adverse effects (e.g., long-term prescription opioid dependence, misuse,&#xD;
      or overdose). The investigators believe there is profound potential to intervene at the sleep&#xD;
      level, and, by improving sleep quality, enable Veterans with chronic mTBI to better manage&#xD;
      their pain and end this vicious cycle.&#xD;
&#xD;
      This proposal aims to apply a sleep intervention to improve chronic pain in Veterans with&#xD;
      mTBI. The investigators propose to use morning bright light therapy (MBLT), a readily&#xD;
      deployable, cost-effective, non-pharmacologic, and home-based sleep intervention, to improve&#xD;
      sleep-wake disturbances and therefore ameliorate chronic pain and improve quality of life in&#xD;
      Veterans with chronic mTBI. Outcomes will be assessed pre- and post-intervention, and at a&#xD;
      3-month follow-up time point. The central hypothesis is that MBLT will improve sleep quality&#xD;
      and ameliorate pain, resulting in improved quality of life in Veterans with chronic mTBI.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">November 1, 2019</start_date>
  <completion_date type="Anticipated">December 31, 2023</completion_date>
  <primary_completion_date type="Anticipated">August 31, 2023</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <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.</intervention_model_description>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>Single (Participant)</masking>
    <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.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>self-reported pain change determined via the NIH PROMIS scale</measure>
    <time_frame>Pre- and post-4 weeks of MBLT or sham treatment, and 12 weeks following the end of MBLT or sham treatment</time_frame>
    <description>NIH PROMIS Pain Scale 4 questions; each question is a 0-4 scale, total score range is 0-16 Higher scores represent worse outcomes</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">100</enrollment>
  <condition>Traumatic Brain Injury</condition>
  <arm_group>
    <arm_group_label>Morning Bright Light Therapy</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Morning bright light: Sitting in front of a lightbox for 60 minutes every morning within 90 minutes of waking up.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Negative Ion Generator</arm_group_label>
    <arm_group_type>Sham Comparator</arm_group_type>
    <description>Negative ion generator: Sitting in front of a modified negative ion generator for 60 min every morning within 90 minutes of waking up.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Morning Bright Light Therapy</intervention_name>
    <description>Morning bright light: Sitting in front of a lightbox for 60 minutes every morning within 90 minutes of waking up.</description>
    <arm_group_label>Morning Bright Light Therapy</arm_group_label>
    <other_name>Lightbox, light therapy</other_name>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Negative Ion Generator</intervention_name>
    <description>Negative ion generator: Sitting in front of a modified negative ion generator for 60 min every morning within 90 minutes of waking up.</description>
    <arm_group_label>Negative Ion Generator</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Veteran&#xD;
&#xD;
          -  Medical record-confirmed diagnosis of mTBI&#xD;
&#xD;
          -  Current self-reported sleep-wake disturbances&#xD;
&#xD;
               -  defined by clinically abnormal Insomnia Severity Index and/or Functional Outcomes&#xD;
                  of Sleep scores&#xD;
&#xD;
          -  Moderate to severe pain&#xD;
&#xD;
               -  defined as a score of 4 on an 11-point scale94) persisting for longer than 6&#xD;
                  months&#xD;
&#xD;
          -  English speaking with phone access&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Decisional impairment and/or dementia&#xD;
&#xD;
          -  Current usage of a lightbox or negative ion generator&#xD;
&#xD;
          -  Shift work&#xD;
&#xD;
          -  History of macular degeneration and/or bipolar disorder&#xD;
&#xD;
          -  Evidence for suicidal ideation&#xD;
&#xD;
          -  Cancer diagnosis within the past 6 months&#xD;
&#xD;
          -  Surgery within the past 6-12 months&#xD;
&#xD;
          -  Substance abuse within the past 6-12 months&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jonathan E Elliott, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>VA Portland Health Care System, Portland, OR</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Sharon D Jacky</last_name>
    <phone>(503) 220-8262</phone>
    <phone_ext>58346</phone_ext>
    <email>Sharon.Jacky@va.gov</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Archie (Herman) G Bouwer, PhD</last_name>
    <phone>(503) 220-8262</phone>
    <phone_ext>52900</phone_ext>
    <email>Archie.Bouwer@va.gov</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>VA Portland Health Care System, Portland, OR</name>
      <address>
        <city>Portland</city>
        <state>Oregon</state>
        <zip>97239</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Sharon D Jacky</last_name>
      <phone>503-220-8262</phone>
      <phone_ext>58346</phone_ext>
      <email>Sharon.Jacky@va.gov</email>
    </contact>
    <investigator>
      <last_name>Jonathan E Elliott, PhD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>December 2022</verification_date>
  <study_first_submitted>December 20, 2018</study_first_submitted>
  <study_first_submitted_qc>December 20, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 24, 2018</study_first_posted>
  <last_update_submitted>December 21, 2022</last_update_submitted>
  <last_update_submitted_qc>December 21, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">December 23, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>traumatic brain injury</keyword>
  <keyword>sleep-wake disturbances</keyword>
  <keyword>Veterans</keyword>
  <keyword>chronic pain</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Brain Injuries</mesh_term>
    <mesh_term>Brain Injuries, Traumatic</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03785600
org study id: D2947-W
secondary id: IK2RX002947
nct id: NCT03785600
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
is us export: No
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.
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.
primary purpose: Supportive Care
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.
measure: 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
description: NIH PROMIS Pain Scale 4 questions; each question is a 0-4 scale, total score range is 0-16 Higher scores represent worse outcomes
arm group label: Morning Bright Light Therapy
arm group type: Experimental
description: Morning bright light: Sitting in front of a lightbox for 60 minutes every morning within 90 minutes of waking up.
arm group label: Negative Ion Generator
arm group type: Sham Comparator
description: Negative ion generator: Sitting in front of a modified negative ion generator for 60 min every morning within 90 minutes of waking up.
intervention type: Device
intervention name: Morning Bright Light Therapy
description: Morning bright light: Sitting in front of a lightbox for 60 minutes every morning within 90 minutes of waking up.
arm group label: Morning Bright Light Therapy
other name: Lightbox, light therapy
intervention type: Device
intervention name: Negative Ion Generator
description: Negative ion generator: Sitting in front of a modified negative ion generator for 60 min every morning within 90 minutes of waking up.
arm group label: Negative Ion Generator
criteria: 
gender: All
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: No
last name: Jonathan E Elliott, PhD
role: Principal Investigator
affiliation: VA Portland Health Care System, Portland, OR
last name: Sharon D Jacky
phone: (503) 220-8262
phone ext: 58346
email: Sharon.Jacky@va.gov
last name: Archie (Herman) G Bouwer, PhD
phone: (503) 220-8262
phone ext: 52900
email: Archie.Bouwer@va.gov
facility: 
status: Recruiting
contact: 
investigator: 
country: United States
responsible party type: Sponsor
mesh term: Brain Injuries
mesh term: Brain Injuries, Traumatic
sharing ipd: No