Improving Sleep in Veterans With TBI

Traumatic Brain Injury Clinical Trial

— SPTBI  

Official title:

A Sleep Intervention to Improve Rehabilitation in Veterans With Chronic mTBI

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03785600
• Other study ID #: D2947-W
• Secondary ID: IK2RX002947
• Status: Recruiting
• Phase: N/A
• Start date: November 1, 2019
• Est. completion date: September 30, 2024

Study information

• Verified date: June 2024
• Source: VA Office of Research and Development
• Contact: Jonathan E Elliott, PhD
• Phone: (503) 220-8262
• Email: jonathan.elliott[@]va.gov
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: September 30, 2024
• Est. primary completion date: July 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Brain Injuries
• Brain Injuries, Traumatic
• Traumatic Brain Injury

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	VA Portland Health Care System, Portland, OR	Portland	Oregon

Sponsors (1)

Lead Sponsor	Collaborator
VA Office of Research and Development

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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