Improving Sleep in Veterans With TBI
CompletedNot applicableNCT03785600
View the official record on ClinicalTrials.gov Recruiting status changes often. Contact the study team listed on ClinicalTrials.gov, and talk to your doctor before joining a study.
This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
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.
Study details
- Official title
- A Sleep Intervention to Improve Rehabilitation in Veterans With Chronic mTBI
- Conditions
- Interventions
- Device: Morning Bright Light Therapy
- Device: Negative Ion Generator
- Sponsor
- VA Office of Research and Development
- Start date
- 2019-11-01
- Primary completion
- 2024-07-31
- Sex
- All
- Age range
- from 18 Years to 70 Years
- Results posted
- Yes, on ClinicalTrials.gov
- Countries
- United States
- Total sites listed
- 1
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
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
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT03785600