Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| IK2RX002947 | U.S. NIH Grant/Contract | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Morning Bright Light Therapy | Experimental | Morning bright light: Sitting in front of a lightbox for 60 minutes every morning within 90 minutes of waking up. |
|
| Negative Ion Generator | Sham Comparator | Negative ion generator: Sitting in front of a modified negative ion generator for 60 min every morning within 90 minutes of waking up. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Morning Bright Light Therapy | Device | Morning bright light: Sitting in front of a lightbox for 60 minutes every morning within 90 minutes of waking up. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Pre- and post-4 weeks of Morning Bright Light Therapy (MBLT) or sham treatment. |
Not provided
Not provided
Inclusion Criteria:
Veteran
Medical record-confirmed diagnosis of mTBI
Current self-reported sleep-wake disturbances
Moderate to severe pain
English speaking with phone access
Exclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Jonathan E Elliott, PhD | VA Portland Health Care System, Portland, OR | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| VA Portland Health Care System, Portland, OR | Portland | Oregon | 97207-2964 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39775195 | Background | Elliott JE, Brewer JS, Keil AT, Ligman BR, Bryant-Ekstrand MD, McBride AA, Powers K, Sicard SJ, Twamley EW, O'Neil ME, Hildebrand AD, Nguyen T, Morasco BJ, Gill JM, Dengler BA, Lim MM. Feasibility and acceptability for LION, a fully remote, randomized clinical trial within the VA for light therapy to improve sleep in Veterans with and without TBI: An MTBI2 sponsored protocol. PLoS One. 2025 Jan 7;20(1):e0305305. doi: 10.1371/journal.pone.0305305. eCollection 2025. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Mean | Standard Deviation | Score on Pain Interference | Pre- and post-4 weeks of Morning Bright Light Therapy (MBLT) or sham treatment. |
|
Adverse event data was collected started immediately after consent and ended after participants completed all study activities (up to 20 weeks).
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Non-Serious | Psychiatric disorders | Non-systematic Assessment | Subject reported anxiety from dark adaptation of Dim Light Melatonin Onset saliva protocol. |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jonathan Elliott | VA Portland Health Care System | 503-220-8262 | 53874 | jonathan.elliott@va.gov |
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Nov 15, 2023 | Jul 31, 2025 | Prot_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Nov 15, 2023 | Nov 19, 2024 | ICF_000.pdf |
Not provided
| ID | Term |
|---|---|
| D000070642 | Brain Injuries, Traumatic |
| D059350 | Chronic Pain |
| ID | Term |
|---|---|
| D001930 | Brain Injuries |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D010789 | Phototherapy |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
Not provided
Not provided
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.
Not provided
Not provided
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.
|
| Negative Ion Generator | Device | 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. 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. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Years of Education | Mean | Standard Deviation | years |
|
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. |
|
|
|
| 0 |
| 53 |
| 0 |
| 53 |
| 0 |
| 53 |
| EG001 | 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. | 0 | 24 | 0 | 24 | 1 | 24 |
|
Not provided
Not provided
Not provided
| D006259 |
| Craniocerebral Trauma |
| D020196 | Trauma, Nervous System |
| D014947 | Wounds and Injuries |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |