Recruiting

Bright Light Therapy

Sponsor:

VA Office of Research and Development

Code:

NCT06477796

Conditions

Traumatic Brain Injury

Post-traumatic Stress Disorder

Chronic Pain

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Morning Bright Light Therapy

Negative Ion Generator

Study Details

Brief summary:

The "polytrauma clinical triad" (PCT), a highly disabling constellation of factors, is defined by the coexistence of traumatic brain injury, post-traumatic stress disorder, and chronic pain. Veterans with the PCT are medically complex, often refractory to conventional therapies, and suffer from additional related chronic sequela. Notably, sleep disturbances and cognitive impairment, which the investigators hypothesize are significant contributing factors to these functional impairments and an impediment toward rehabilitation. Thus, the investigators' research aims to intervene "at the level of sleep", and by improving sleep, improve these interconnected, disabling, and difficult to treat enduring complexities associated with the PCT - ultimately to improve Veteran quality of life, functional independence, and restorative function. The investigators predict that the proposed intervention, morning bright light therapy, which is cost-effective, rapidly deployable and home-based, will be effective in improving sleep and overall PCT symptom management, thereby, resulting in a measurable and impactful improvement in quality of life.

Conditions

Traumatic Brain Injury

Post-traumatic Stress Disorder

Chronic Pain

Study ID

NCT06477796

Start date

May 1, 2025

Status verified date

Jun, 2026

Completion date

Sep 29, 2028

Anticipated

Primary completion date

Dec 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Veteran
  • English speaking with phone and internet access
  • Current self-reported sleep disturbances
  • Clinical stable for current pharmacologic or behavioral health treatments for depression, anxiety, sleep and pain
  • Documented history of TBI

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 months
  • Substance abuse within the past 6-12 months
  • Significant impairing post-stroke residual hemiparesis

Study Design

Enrollment

96 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

experimental: Morning Bright Light Therapy

Morning bright light: Sitting in front of a lightbox for 60 minutes every morning within 120 minutes of waking up.

sham comparator: Negative Ion Generator

Negative ion generator: Sitting in front of a modified negative ion generator for 60 min every morning within 120 minutes of waking up.

Interventions

Morning Bright Light Therapy

Morning bright light: Sitting in front of a lightbox for 60 minutes every morning within 120 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 120 minutes of waking up.

Primary outcome measure

  • Sleep Efficiency via wrist based actigraphy [ Time Frame: Pre- and post-4 weeks of MBLT or sham treatment ]

Central Contacts and Locations

Central contacts

Locations

VA Portland Health Care System, Portland, OR

Recruiting

Portland, Oregon, United States, 97207-2964

Contacts

Principal Investigator:

Jonathan E Elliott, PhD

More Information

Sponsor

VA Office of Research and Development

Last update posted

Jun 29, 2026

Last verified

Jun, 2026

Keywords

  • polytrauma clinical triad
  • TBI
  • PTSD

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by VA Office of Research and Development on 2026-06-29.