An interventional study of Morning Bright Light Therapy and Negative Ion Generator in Traumatic Brain Injury, sponsored by VA Office of Research and Development. Completed at 1 site in United States. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2025-09-22.
Sponsored by VA Office of Research and Development · Not applicable, Interventional, and Supportive care
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.
Each year \~2.5 million people sustain a traumatic brain injury (TBI). Also a prominent general public health issue, TBI is particularly prevalent in Veterans, with 60-80% reporting a history of TBI. Over 80% of all TBI are categorized as mild TBI (mTBI), which is associated with a myriad of short- and long-term complications. Two of the principal complicating factors associated with mTBI are sleep-wake disturbances (e.g., insomnia, excessive daytime sleepiness, and circadian rhythm sleep disorders) and chronic pain, including headache and diffuse/global pain. Sleep-wake disturbances and chronic pain have an independent prevalence of \~70%, individually impair quality of life, impede effective rehabilitative therapies, and have staggering functional and economic impacts.
Furthermore, there is a strong bidirectional relationship between sleep-wake disturbances and pain such that impaired sleep exacerbates pain, which leads to greater impairments in sleep and worse pain. This vicious cycle between sleep disturbances and pain, which is a particularly prevalent and detrimental condition in Veterans with chronic mTBI, represents a central challenge precluding effective treatment and ultimately, improving Veteran quality of life. Although there are pharmacological and non-pharmacological therapies for chronic pain, the presence of TBI significantly complicates the effectiveness of these treatment options, and have significant adverse effects (e.g., long-term prescription opioid dependence, misuse, or overdose). The investigators believe there is profound potential to intervene at the sleep level, and, by improving sleep quality, enable Veterans with chronic mTBI to better manage their pain and end this vicious cycle.
This proposal aims to apply a sleep intervention to improve chronic pain in Veterans with mTBI. The investigators propose to use morning bright light therapy (MBLT), a readily deployable, cost-effective, non-pharmacologic, and home-based sleep intervention, to improve sleep-wake disturbances and therefore ameliorate chronic pain and improve quality of life in Veterans with chronic mTBI. Outcomes will be assessed pre- and post-intervention, and at a 3-month follow-up time point. The central hypothesis is that MBLT will improve sleep quality and ameliorate pain, resulting in improved quality of life in Veterans with chronic mTBI.
1,775 studies on the registry are indexed under Brain Injuries, Traumatic; 448 are open to participants now.
This study's enrollment of 77 is above the median of 56 across 1,133 interventional studies indexed under Brain Injuries, Traumatic.
Browse Brain Injuries, Traumatic studies →VA Office of Research and Development is the lead sponsor of 1,733 studies on the registry; 396 are open to participants now.
Of its 206 completed or terminated interventional studies of FDA-regulated products, 180 (87%) have results posted.
Counted across the registry records on this site, refreshed daily.
Inclusion Criteria:
Current self-reported sleep-wake disturbances
Moderate to severe pain
Exclusion Criteria:
Exclusion Criteria:
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: Sitting in front of a modified negative ion generator for 60 min every morning within 90 minutes of waking up.
Device: Negative Ion Generator
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
Negative ion generator: Sitting in front of a modified negative ion generator for 60 min every morning within 90 minutes of waking up.
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.
Time frame: Pre- and post-4 weeks of Morning Bright Light Therapy (MBLT) or sham treatment.
| Milestone | Morning Bright Light Therapy | Negative Ion Generator |
|---|---|---|
| Started | 53 | 24 |
| Completed | 44 | 20 |
| Not completed | 9 | 4 |
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.
| Score on Pain Interference | Morning Bright Light Therapy | Negative Ion Generator |
|---|---|---|
| Mean Pre-Intervention Pain Interference | 9.8 ± 4.8 | 10.2 ± 4.7 |
| Mean Post-Intervention Pain Interference | 9.3 ± 4.8 | 10.0 ± 5.0 |
Collected over Adverse event data was collected started immediately after consent and ended after participants completed all study activities (up to 20 weeks).. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Morning Bright Light Therapy | 0/53 (0%) | 0/53 (0%) | 0/53 (0%) |
| Negative Ion Generator | 0/24 (0%) | 0/24 (0%) | 1/24 (4.2%) |
| Event | Morning Bright Light Therapy | Negative Ion Generator |
|---|---|---|
| Non-SeriousPsychiatric disorders | 0/53 | 1/24 |
| Age, Continuous(years) | Morning Bright Light Therapy | Negative Ion Generator | Total |
|---|---|---|---|
| Mean | 53.6 ± 13.4 | 51.8 ± 14.3 | 53.1 ± 13.6 |
| Sex: Female, Male(Participants) | Morning Bright Light Therapy | Negative Ion Generator | Total |
|---|---|---|---|
| Female | 10 | 4 | 14 |
| Male | 34 | 16 | 50 |
| Ethnicity (NIH/OMB)(Participants) | Morning Bright Light Therapy | Negative Ion Generator | Total |
|---|---|---|---|
| Hispanic or Latino | 7 | 0 | 7 |
| Not Hispanic or Latino | 37 | 19 | 56 |
| Unknown or Not Reported | 0 | 1 | 1 |
| Race (NIH/OMB)(Participants) | Morning Bright Light Therapy | Negative Ion Generator | Total |
|---|---|---|---|
| American Indian or Alaska Native | 3 | 1 | 4 |
| Asian | 0 | 1 | 1 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 1 | 0 | 1 |
| White | 38 | 16 | 54 |
| More than one race | 2 | 1 | 3 |
| Unknown or Not Reported | 0 | 1 | 1 |
| Years of Education(years) | Morning Bright Light Therapy | Negative Ion Generator | Total |
|---|---|---|---|
| Mean | 16.5 ± 1.8 | 15.6 ± 1.9 | 16.2 ± 1.9 |
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