Improving Sleep in Veterans With TBI

NCT ID: NCT03785600

Last Updated: 2025-09-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 77 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-11-01
• Study Completion Date: 2024-09-30

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.

Conditions

Traumatic Brain Injury

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

Morning Bright Light Therapy

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

Group Type: EXPERIMENTAL

Morning Bright Light Therapy

Intervention Type: DEVICE

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.

Group Type: SHAM_COMPARATOR

Negative Ion Generator

Intervention Type: DEVICE

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

Interventions

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 Type: 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.

Intervention Type: DEVICE

Other Intervention Names

Lightbox, light therapy

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

• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

VA Office of Research and Development

FED

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jonathan E Elliott, PhD

Role: PRINCIPAL_INVESTIGATOR

VA Portland Health Care System, Portland, OR

Locations

VA Portland Health Care System, Portland, OR

Portland, Oregon, United States

Countries

United States

References

Elliott JE, Brewer JS, Keil AT, Ligman BR, Bryant-Ekstrand MD, McBride AA, Powers K, Sicard SJ, Twamley EW, O'Neil ME, Hildebrand AD, Nguyen T, Morasco BJ, Gill JM, Dengler BA, Lim MM. Feasibility and acceptability for LION, a fully remote, randomized clinical trial within the VA for light therapy to improve sleep in Veterans with and without TBI: An MTBI2 sponsored protocol. PLoS One. 2025 Jan 7;20(1):e0305305. doi: 10.1371/journal.pone.0305305. eCollection 2025.

Reference Type: BACKGROUND

PMID: 39775195 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

IK2RX002947

Identifier Type: NIH

Identifier Source: secondary_id

View Link

D2947-W

Identifier Type: -

Identifier Source: org_study_id