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Improving Sleep in Veterans With TBI (SPTBI)

Primary Purpose

Traumatic Brain Injury

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Morning Bright Light Therapy
Negative Ion Generator
Sponsored by
VA Office of Research and Development
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Traumatic Brain Injury focused on measuring traumatic brain injury, sleep-wake disturbances, Veterans, chronic pain

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • VA Portland Health Care System, Portland, ORRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Morning Bright Light Therapy

Negative Ion Generator

Arm Description

Morning bright light: Sitting in front of a lightbox for 60 minutes every morning within 90 minutes of waking up.

Negative ion generator: Sitting in front of a modified negative ion generator for 60 min every morning within 90 minutes of waking up.

Outcomes

Primary Outcome Measures

self-reported pain change determined via the NIH PROMIS scale
NIH PROMIS Pain Scale 4 questions; each question is a 0-4 scale, total score range is 0-16 Higher scores represent worse outcomes

Secondary Outcome Measures

Full Information

First Posted
December 20, 2018
Last Updated
September 28, 2023
Sponsor
VA Office of Research and Development
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1. Study Identification

Unique Protocol Identification Number
NCT03785600
Brief Title
Improving Sleep in Veterans With TBI
Acronym
SPTBI
Official Title
A Sleep Intervention to Improve Rehabilitation in Veterans With Chronic mTBI
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 1, 2019 (Actual)
Primary Completion Date
January 31, 2024 (Anticipated)
Study Completion Date
March 29, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
VA Office of Research and Development

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Traumatic Brain Injury
Keywords
traumatic brain injury, sleep-wake disturbances, Veterans, chronic pain

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
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.
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Morning Bright Light Therapy
Arm Type
Experimental
Arm Description
Morning bright light: Sitting in front of a lightbox for 60 minutes every morning within 90 minutes of waking up.
Arm Title
Negative Ion Generator
Arm Type
Sham Comparator
Arm 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(s)
Morning Bright Light Therapy
Other Intervention Name(s)
Lightbox, light therapy
Intervention Description
Morning bright light: Sitting in front of a lightbox for 60 minutes every morning within 90 minutes of waking up.
Intervention Type
Device
Intervention Name(s)
Negative Ion Generator
Intervention Description
Negative ion generator: Sitting in front of a modified negative ion generator for 60 min every morning within 90 minutes of waking up.
Primary Outcome Measure Information:
Title
self-reported pain change determined via the NIH PROMIS scale
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
Time Frame
Pre- and post-4 weeks of MBLT or sham treatment, and 12 weeks following the end of MBLT or sham treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jonathan E Elliott, PhD
Phone
(503) 220-8262
Email
jonathan.elliott@va.gov
First Name & Middle Initial & Last Name or Official Title & Degree
Joshua P Kreider
Phone
(503) 220-8262
Ext
53851
Email
Joshua.Kreider@va.gov
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jonathan E Elliott, PhD
Organizational Affiliation
VA Portland Health Care System, Portland, OR
Official's Role
Principal Investigator
Facility Information:
Facility Name
VA Portland Health Care System, Portland, OR
City
Portland
State/Province
Oregon
ZIP/Postal Code
97207-2964
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jonathan E Elliott, PhD
Phone
503-220-8262
Email
jonathan.elliott@va.gov
First Name & Middle Initial & Last Name & Degree
Jonathan E Elliott, PhD

12. IPD Sharing Statement

Plan to Share IPD
No

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Improving Sleep in Veterans With TBI

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