Traumatic Brain InjurySPTBINCT03785600
Improving Sleep in Veterans With TBI
A study testing Morning Bright Light Therapy and Negative Ion Generator in people with Traumatic Brain Injury, run by VA Office of Research and Development at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Traumatic Brain Injury
- What is being tested?
- Morning Bright Light Therapy and Negative Ion Generator
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 77 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Nov 2019to 30 Sep 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
VA Portland Health Care System, Portland, OR
Portland, Oregon, 97207-2964
About this study
Official title: A Sleep Intervention to Improve Rehabilitation in Veterans With Chronic mTBI
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.
Read the 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.
- Conditions
- Traumatic Brain Injury
- Being tested
- Morning Bright Light Therapy, Negative Ion Generator
- Keywords
- traumatic brain injury, sleep-wake disturbances, Veterans, chronic pain
- Medical subject headings
- Brain Injuries, Traumatic, Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Morning Bright Light TherapyDevice
Also called Lightbox, light therapy
Morning bright light: Sitting in front of a lightbox for 60 minutes every morning within 90 minutes of waking up.
Negative Ion GeneratorDevice
Negative ion generator: Sitting in front of a modified negative ion generator for 60 min every morning within 90 minutes of waking up.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Morning Bright Light Therapy |
| 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. Receives: Device: Negative Ion Generator |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Pre- and post-4 weeks of Morning Bright Light Therapy (MBLT) or sham treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2018
- Study start1 Nov 2019
- Primary completion31 Jul 2024
- Study completion30 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Traumatic Brain InjuryStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 77 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Jonathan E Elliott, PhD, Principal investigator, VA Portland Health Care System, Portland, OR
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03785600
- Sponsor's protocol ID
- D2947-W
- Other IDs
- IK2RX002947
- Acronym
- SPTBI
- Status last verified
- Sep 2025
- First submitted
- 20 Dec 2018
- Last updated
- 22 Sep 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 39775195
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Sleep Intervention to Improve Rehabilitation in Veterans With Chronic mTBI
- ClinicalTrials.gov ID
- NCT03785600
- Acronym / sponsor ID
- SPTBI / D2947-W
- Conditions
- Traumatic Brain Injury
- Keywords
- traumatic brain injury, sleep-wake disturbances, Veterans, chronic pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 77 participants (actual)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- 1 Nov 2019 (actual)
- Primary completion
- 31 Jul 2024 (actual)
- Study completion
- 30 Sep 2024 (actual)
- First posted
- 24 Dec 2018 (actual)
- Results
- Posted 22 Sep 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Morning Bright Light Therapy | Experimental | Device: Morning Bright Light TherapyMorning bright light: Sitting in front of a lightbox for 60 minutes every morning within 90 minutes of waking up. |
| Negative Ion Generator | Sham comparator | Device: Negative Ion GeneratorNegative ion generator: Sitting in front of a modified negative ion generator for 60 min every morning within 90 minutes of waking up. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Veteran
- Medical record-confirmed diagnosis of mTBI
- Current self-reported sleep-wake disturbances
- Moderate to severe pain
- English speaking with phone access
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Morning Bright Light TherapyAlso: Lightbox, light therapyMorning 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 GeneratorNegative 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 |
Primary outcome
Change in Self-reported Pain
Time frame: 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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 39775195Elliott 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jonathan E Elliott, PhD principal investigator
VA Portland Health Care System, Portland, OR
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Morning Bright Light Therapy and Negative Ion Generator in people with Traumatic Brain Injury, run by VA Office of Research and Development at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 22 Sep 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Self-reported Pain (time frame: Pre- and post-4 weeks of Morning Bright Light Therapy (MBLT) or sham treatment.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03785600, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Sep 2025.