Improving Sleep in Veterans With TBI (SPTBI)

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.

Study Overview

• Status: Recruiting
• Conditions: Traumatic Brain Injury
• Intervention / Treatment: Device: Morning Bright Light Therapy; Device: Negative Ion Generator

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: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jonathan E Elliott, PhD; Phone Number: (503) 220-8262; Email: jonathan.elliott@va.gov
• Study Contact Backup: Name: Joshua P Kreider; Phone Number: 53851 (503) 220-8262; Email: Joshua.Kreider@va.gov

Study Locations

• United States
  • Oregon
    • Portland, Oregon, United States, 97207-2964
      • Recruiting
      • VA Portland Health Care System, Portland, OR
      • Principal Investigator: Jonathan E Elliott, PhD
      • Contact: Jonathan E Elliott, PhD; Phone Number: 503-220-8262; Email: jonathan.elliott@va.gov

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 68 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	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 Names: Lightbox, 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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Pre- and post-4 weeks of MBLT or sham treatment, and 12 weeks following the end of MBLT or sham treatment

Collaborators and Investigators

• Sponsor: VA Office of Research and Development
• Investigators: Principal Investigator: Jonathan E Elliott, PhD, VA Portland Health Care System, Portland, OR

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2019
• Primary Completion (Estimated): May 31, 2024
• Study Completion (Estimated): June 30, 2024

Study Registration Dates

• First Submitted: December 20, 2018
• First Submitted That Met QC Criteria: December 20, 2018
• First Posted (Actual): December 24, 2018

Study Record Updates

• Last Update Posted (Actual): February 28, 2024
• Last Update Submitted That Met QC Criteria: February 26, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: chronic pain; Veterans; traumatic brain injury; sleep-wake disturbances
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Wounds and Injuries; Craniocerebral Trauma; Trauma, Nervous System; Brain Injuries; Brain Injuries, Traumatic
• Other Study ID Numbers: D2947-W; IK2RX002947 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• 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