Traumatic Brain Injury
Conditions
Keywords
traumatic brain injury, sleep-wake disturbances, Veterans, chronic pain
Brief 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.
Detailed description
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.
Interventions
Morning bright light: Sitting in front of a lightbox for 60 minutes every morning within 90 minutes of waking up.
Negative ion generator: Sitting in front of a modified negative ion generator for 60 min every morning within 90 minutes of waking up.
Sponsors
Study design
Masking description
Participants will be blinded to the intervention by way of study personnel's description. Subjects will be told that both devices may or may not be active and thus, will be unaware that all light boxes are active and all negative ion generators are inactivated.
Intervention model description
Subjects will be randomized to receive MBLT or a sham/no-light control. Subjects randomized to receive MBLT will be given a light box (LightPad, Aurora Light Solutions) to take home. Subjects randomized to receive the sham/no-light control will be given a modified negative ion generator.
Eligibility
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Self-reported Pain | Pre- and post-4 weeks of Morning Bright Light Therapy (MBLT) or sham treatment. | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Morning Bright Light Therapy Morning bright light: Sitting in front of a lightbox for 60 minutes every morning within 90 minutes of waking up.
Morning Bright Light Therapy: Morning bright light: Sitting in front of a lightbox for 60 minutes every morning within 90 minutes of waking up. | 44 |
| Negative Ion Generator Negative ion generator: Sitting in front of a modified negative ion generator for 60 min every morning within 90 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 90 minutes of waking up. | 20 |
| Total | 64 |
Baseline characteristics
| Characteristic | Morning Bright Light Therapy | Total | Negative Ion Generator |
|---|---|---|---|
| Age, Continuous | 53.6 years STANDARD_DEVIATION 13.4 | 53.1 years STANDARD_DEVIATION 13.6 | 51.8 years STANDARD_DEVIATION 14.3 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 7 Participants | 7 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 37 Participants | 56 Participants | 19 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 3 Participants | 4 Participants | 1 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 2 Participants | 3 Participants | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) White | 38 Participants | 54 Participants | 16 Participants |
| Sex: Female, Male Female | 10 Participants | 14 Participants | 4 Participants |
| Sex: Female, Male Male | 34 Participants | 50 Participants | 16 Participants |
| Years of Education | 16.5 years STANDARD_DEVIATION 1.8 | 16.2 years STANDARD_DEVIATION 1.9 | 15.6 years STANDARD_DEVIATION 1.9 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 53 | 0 / 24 |
| other Total, other adverse events | 0 / 53 | 1 / 24 |
| serious Total, serious adverse events | 0 / 53 | 0 / 24 |
Outcome results
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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Morning Bright Light Therapy | Change in Self-reported Pain | Mean Pre-Intervention Pain Interference | 9.8 Score on Pain Interference | Standard Deviation 4.8 |
| Morning Bright Light Therapy | Change in Self-reported Pain | Mean Post-Intervention Pain Interference | 9.3 Score on Pain Interference | Standard Deviation 4.8 |
| Negative Ion Generator | Change in Self-reported Pain | Mean Pre-Intervention Pain Interference | 10.2 Score on Pain Interference | Standard Deviation 4.7 |
| Negative Ion Generator | Change in Self-reported Pain | Mean Post-Intervention Pain Interference | 10.0 Score on Pain Interference | Standard Deviation 5 |