N/A
N=77
Improving Sleep in Veterans With TBI
Traumatic Brain Injury
Bottom Line
View on ClinicalTrials.gov: NCT03785600 ↗Enrolled (actual)
77
Serious AEs
0.0%
Results posted
Sep 2025
Primary outcome: Primary: Change in Self-reported Pain — 9.8; 10.2; 9.3; 10.0 Score on Pain Interference — p=<0.02
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Morning Bright Light Therapy (Device); Negative Ion Generator (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- VA Office of Research and Development
- Primary completion
- Jul 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Self-reported Pain |
9.8; 10.2; 9.3; 10.0 | <0.02 sig |
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.
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
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
Data sourced from ClinicalTrials.gov (NCT03785600). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.