Improving Sleep in Veterans With TBI

NCT03785600 | Completed Results

• 2 other identifiers: D2947-WIK2RX002947
• Study Type: interventional
• Target: 77
• Locations: 1 country
• Sites: 1

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.

Conditions

Traumatic Brain Injury

Keywords

traumatic brain injury; sleep-wake disturbances; Veterans; chronic pain

Outcome Measures

Primary Outcomes (1)

• Change in Self-reported Pain

  NIH Patient Reported Outcomes Measurement Information System (PROMIS) pain interference short-form 4a. 4 questions; each question is a 1-5 Likert scale, total score range is 4-20. Higher scores represent greater pain interference. \*all are reported as total score, no subscale scores present.

  Pre- and post-4 weeks of Morning Bright Light Therapy (MBLT) or sham treatment.

Study Arms (2)

Morning Bright Light Therapy

EXPERIMENTAL

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

Negative Ion Generator

SHAM COMPARATOR

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

Interventions

Morning Bright Light Therapy DEVICE

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

Also known as: Lightbox, light therapy

Morning Bright Light Therapy

Negative Ion Generator DEVICE

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

Negative Ion Generator

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (1)

VA Portland Health Care System, Portland, OR

Portland, Oregon, 97207-2964, United States

Location

Related Publications (1)

• 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.

  PMID: 39775195 BACKGROUND

MeSH Terms

Conditions

Brain Injuries, Traumatic; Chronic Pain

Interventions

Phototherapy

Condition Hierarchy (Ancestors)

Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Therapeutics

Results Point of Contact

• Title: Jonathan Elliott
• Organization: VA Portland Health Care System

jonathan.elliott@va.gov

503-220-8262

Study Officials

• Jonathan E Elliott, PhD

  VA Portland Health Care System, Portland, OR

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: 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.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: December 20, 2018
• First Posted: December 24, 2018
• Study Start: November 1, 2019
• Primary Completion: July 31, 2024
• Study Completion: September 30, 2024
• Last Updated: September 22, 2025
• Results First Posted: September 22, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)