Improving sleep for Veterans with traumatic brain injury, PTSD, and chronic pain
A Sleep Intervention to Improve Quality of Life and Symptom Management in Veterans With the Polytrauma Clinical Triad
NA · VA Office of Research and Development · NCT06477796
We will try morning bright light therapy at home to improve sleep for Veterans who have TBI, PTSD, and chronic pain.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 96 (estimated) |
| Ages | 18 Years to 89 Years |
| Sex | All |
| Sponsor | VA Office of Research and Development (fed) |
| Locations | 1 site (Portland, Oregon) |
| Trial ID | NCT06477796 on ClinicalTrials.gov |
What this trial studies
This trial tests a home-based morning bright light therapy intervention, with a negative ion generator used as a comparator, in Veterans who have the polytrauma clinical triad (TBI, PTSD, and chronic pain). Participants are Veterans with documented TBI and current self-reported sleep disturbances who are clinically stable on current behavioral or pharmacologic treatments. Outcomes include sleep measures, cognitive function, pain severity, PTSD symptoms, and functional quality of life using standardized surveys and tests. The approach is non-pharmacologic, low-cost, and designed for rapid home deployment to break the cycle of poor sleep worsening related sequela and vice versa.
Who should consider this trial
Good fit: Veterans with a documented history of TBI who report current sleep disturbances, speak English, have phone and internet access, and are clinically stable on current psychiatric or pain treatments.
Not a fit: Those with decisional impairment or dementia, active bipolar disorder or macular degeneration, current use of a lightbox or ion generator, shift work, recent cancer or surgery, recent substance abuse, suicidal ideation, or significant post-stroke hemiparesis are excluded and unlikely to benefit from this protocol.
Why it matters
Potential benefit: If effective, morning bright light therapy could improve sleep and downstream problems like pain, cognitive difficulties, and PTSD symptoms, helping Veterans regain daily functioning and quality of life.
How similar studies have performed: Bright light therapy has shown benefits for sleep and mood in other populations and early work from these investigators shows promise, but large-scale evidence specifically in the polytrauma clinical triad is limited.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Portland, Oregon
- VA Portland Health Care System, Portland, OR — Portland, Oregon, United States (RECRUITING)
Study contacts
- Principal investigator: Jonathan E Elliott, PhD — VA Portland Health Care System, Portland, OR
- Study coordinator: Jonathan E Elliott, PhD
- Email: jonathan.elliott@va.gov
- Phone: (503) 220-8262
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Traumatic Brain Injury, Post-traumatic Stress Disorder, Chronic Pain, polytrauma clinical triad, TBI, PTSD