Traumatic Brain InjuryLIONv2NCT06477796
Improving Sleep in Veterans With the Polytrauma Clinical Triad
A study testing Morning Bright Light Therapy and Negative Ion Generator in people with Traumatic Brain Injury and Post-traumatic Stress Disorder, run by VA Office of Research and Development at 1 site in United States.
Trial summary
The "polytrauma clinical triad" (PCT), a highly disabling constellation of factors, is defined by the coexistence of traumatic brain injury, post-traumatic stress disorder, and chronic pain. Read more about this study
- Who is it for?
- Ages 18 to 89 years
- Conditions the study is for
- Traumatic Brain Injury, Post-traumatic Stress Disorder, Chronic Pain
- 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
- 96 participants
- Where
- 1 siteUnited States
- Study dates
- 1 May 2025to 29 Sep 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 89 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Veteran
- English speaking with phone and internet access
- Current self-reported sleep disturbances
- Clinical stable for current pharmacologic or behavioral health treatments for depression, anxiety, sleep and pain
- Documented history of TBI
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
Show all 9Show fewer
- Surgery within the past 6 months
- Substance abuse within the past 6-12 months
- Significant impairing post-stroke residual hemiparesis
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
VA Portland Health Care System, Portland, OR
Portland, Oregon, 97207-2964
Jonathan E Elliott, PhD, (503) 220-8262, jonathan.elliott@va.gov
Jonathan E Elliott, PhD
About this study
Official title: A Sleep Intervention to Improve Quality of Life and Symptom Management in Veterans With the Polytrauma Clinical Triad
The "polytrauma clinical triad" (PCT), a highly disabling constellation of factors, is defined by the coexistence of traumatic brain injury, post-traumatic stress disorder, and chronic pain. Veterans with the PCT are medically complex, often refractory to conventional therapies, and suffer from additional related chronic sequela. Notably, sleep disturbances and cognitive impairment, which the investigators hypothesize are significant contributing factors to these functional impairments and an impediment toward rehabilitation. Thus, the investigators' research aims to intervene "at the level of sleep", and by improving sleep, improve these interconnected, disabling, and difficult to treat enduring complexities associated with the PCT - ultimately to improve Veteran quality of life, functional independence, and restorative function. The investigators predict that the proposed intervention, morning bright light therapy, which is cost-effective, rapidly deployable and home-based, will be effective in improving sleep and overall PCT symptom management, thereby, resulting in a measurable and impactful improvement in quality of life.
Read the detailed description
The co-existence of traumatic brain injury, post-traumatic stress disorder (PTSD), and chronic pain defines the clinical entity referred to as the "polytrauma clinical triad" (PCT). Well recognized to be highly prevalent and disabling in US military service members and Veterans, those with the PCT are traditionally viewed as the most disabled cases and most refractory to conventional therapies. Central to the challenge in effectively treating Veterans with the PCT is the bi-directional, mutually reinforcing relationship between these conditions. Further complicating is the influence of sleep and cognitive impairment, both of which are widely regarded as primary contributing chronic sequela associated with the PCT. The specific contribution from sleep in exacerbating this clinical picture is supported by extensive scientific precedent demonstrating impairments in sleep intensify and worsen these related sequela (e.g., cognitive impairment, pain management, and PTSD symptom severity), which in turn, contribute to further impairment in sleep. Accordingly, an effective intervention targeting sleep may alleviate rehabilitative pressure on these associated sequelae and facilitate breaking out of this vicious cycle (i.e., poor sleep exacerbating outcomes, and in turn, further impairing sleep).
Recent work from the investigators' laboratory demonstrate promise for a simple, at home, non-pharmacologic and cost-effective, sleep focused intervention: morning bright light therapy (MBLT). The investigators have demonstrated robust feasibility, acceptability, and limited efficacy for MBLT to improve sleep, and thereby, improve cognitive function, PCT symptom management and overall quality of life in this medically complex and vulnerable population. Accordingly, this proposal aims to extend the foundational work from the CDA-2 to inform a prospective phase II placebo-controlled randomized clinical trial examining effectiveness for MBLT as a sleep- based intervention in Veterans with the PCT.
Specific aims designed to test this hypothesis are to determine effectiveness for MBLT to improve 1) sleep, 2) cognition, and 3) PCT symptom management in Veterans with the PCT. The investigators propose to enroll n=138 Veterans, randomized 2:1 to MBLT (10,000 lux light exposure for 60 min within 120 min of waking for 4-weeks) or a no- light sham-MBLT condition (as previously published using the same duration/timing). Sleep, cognition and PCT symptom management will be assessed through a novel combination of subjective/self-report, objective measures, and ecological momentary assessment sampling. Specific objective assessments include wrist- based actigraphy and as exploratory outcome in a sub-set of participants, home-based overnight polysomnography. Outcomes will be assessed pre- and post-intervention, with follow-up at 6- and 12-weeks post-intervention.
It is expected the proposed work will demonstrate effectiveness for MBLT to improve sleep, cognition, and PCT symptom management including ameliorating chronic pain and improving quality of life, in Veterans with the PCT. This project will demonstrate, 1) an effective treatment option, alone or in combination with existing rehabilitative efforts, in Veterans with the PCT, and 2) sleep-wake disturbances may be implicated in the pathogenesis of these functional impairments, thereby establishing greater precedent for targeting sleep as a meaningful primary and/or adjunctive rehabilitative therapy.
- Being tested
- Morning Bright Light Therapy, Negative Ion Generator
- Keywords
- polytrauma clinical triad, TBI, PTSD
- Medical subject headings
- Brain Injuries, Traumatic, Stress Disorders, Post-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 120 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 120 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 120 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 120 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.
Sleep Efficiency via wrist based actigraphy
Sleep efficiency is defined by the total time asleep divided by total time spent in bed
Measured: Pre- and post-4 weeks of MBLT or sham treatment
Secondary outcomes (1)
Self-reported sleep quality via the Pittsburgh Sleep Quality Index
The Pittsburgh Sleep Quality Index is a validated questionnaire assessing metrics related to sleep quality.
Measured: Pre- and post-4 weeks of 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 posted27 Jun 2024
- Study start1 May 2025
- Primary completion1 Dec 2027 (estimated)
- Study completion29 Sep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 96 participants (estimated)
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
- NCT06477796
- Sponsor's protocol ID
- D4822-R
- Other IDs
- I01RX004822
- Acronym
- LIONv2
- Status last verified
- Jun 2026
- First submitted
- 21 Jun 2024
- Last updated
- 29 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Sleep Intervention to Improve Quality of Life and Symptom Management in Veterans With the Polytrauma Clinical Triad
- ClinicalTrials.gov ID
- NCT06477796
- Acronym / sponsor ID
- LIONv2 / D4822-R
- Keywords
- polytrauma clinical triad, TBI, PTSD
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 96 participants (estimated)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- 1 May 2025 (actual)
- Primary completion
- 1 Dec 2027 (estimated)
- Study completion
- 29 Sep 2028 (estimated)
- First posted
- 27 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The "polytrauma clinical triad" (PCT), a highly disabling constellation of factors, is defined by the coexistence of traumatic brain injury, post-traumatic stress disorder, and chronic pain. Veterans with the PCT are medically complex, often refractory to conventional therapies, and suffer from additional related chronic sequela. Notably, sleep disturbances and cognitive impairment, which the investigators hypothesize are significant contributing factors to these functional impairments and an impediment toward rehabilitation. Thus, the investigators' research aims to intervene "at the level of sleep", and by improving sleep, improve these interconnected, disabling, and difficult to treat enduring complexities associated with the PCT - ultimately to improve Veteran quality of life, functional independence, and restorative function. The investigators predict that the proposed intervention, morning bright light therapy, which is cost-effective, rapidly deployable and home-based, will be effective in improving sleep and overall PCT symptom management, thereby, resulting in a measurable and impactful improvement in quality of life.
Detailed description
The co-existence of traumatic brain injury, post-traumatic stress disorder (PTSD), and chronic pain defines the clinical entity referred to as the "polytrauma clinical triad" (PCT). Well recognized to be highly prevalent and disabling in US military service members and Veterans, those with the PCT are traditionally viewed as the most disabled cases and most refractory to conventional therapies. Central to the challenge in effectively treating Veterans with the PCT is the bi-directional, mutually reinforcing relationship between these conditions. Further complicating is the influence of sleep and cognitive impairment, both of which are widely regarded as primary contributing chronic sequela associated with the PCT. The specific contribution from sleep in exacerbating this clinical picture is supported by extensive scientific precedent demonstrating impairments in sleep intensify and worsen these related sequela (e.g., cognitive impairment, pain management, and PTSD symptom severity), which in turn, contribute to further impairment in sleep. Accordingly, an effective intervention targeting sleep may alleviate rehabilitative pressure on these associated sequelae and facilitate breaking out of this vicious cycle (i.e., poor sleep exacerbating outcomes, and in turn, further impairing sleep).
Recent work from the investigators' laboratory demonstrate promise for a simple, at home, non-pharmacologic and cost-effective, sleep focused intervention: morning bright light therapy (MBLT). The investigators have demonstrated robust feasibility, acceptability, and limited efficacy for MBLT to improve sleep, and thereby, improve cognitive function, PCT symptom management and overall quality of life in this medically complex and vulnerable population. Accordingly, this proposal aims to extend the foundational work from the CDA-2 to inform a prospective phase II placebo-controlled randomized clinical trial examining effectiveness for MBLT as a sleep- based intervention in Veterans with the PCT.
Specific aims designed to test this hypothesis are to determine effectiveness for MBLT to improve 1) sleep, 2) cognition, and 3) PCT symptom management in Veterans with the PCT. The investigators propose to enroll n=138 Veterans, randomized 2:1 to MBLT (10,000 lux light exposure for 60 min within 120 min of waking for 4-weeks) or a no- light sham-MBLT condition (as previously published using the same duration/timing). Sleep, cognition and PCT symptom management will be assessed through a novel combination of subjective/self-report, objective measures, and ecological momentary assessment sampling. Specific objective assessments include wrist- based actigraphy and as exploratory outcome in a sub-set of participants, home-based overnight polysomnography. Outcomes will be assessed pre- and post-intervention, with follow-up at 6- and 12-weeks post-intervention.
It is expected the proposed work will demonstrate effectiveness for MBLT to improve sleep, cognition, and PCT symptom management including ameliorating chronic pain and improving quality of life, in Veterans with the PCT. This project will demonstrate, 1) an effective treatment option, alone or in combination with existing rehabilitative efforts, in Veterans with the PCT, and 2) sleep-wake disturbances may be implicated in the pathogenesis of these functional impairments, thereby establishing greater precedent for targeting sleep as a meaningful primary and/or adjunctive rehabilitative therapy.
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 120 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 120 minutes of waking up. |
Who may qualify
- Ages
- 18 to 89 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Veteran
- English speaking with phone and internet access
- Current self-reported sleep disturbances
- Clinical stable for current pharmacologic or behavioral health treatments for depression, anxiety, sleep and pain
- Documented history of TBI
Key exclusion criteria (9 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 120 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 120 minutes of waking up. | Device | Negative Ion Generator |
Primary outcome
Sleep Efficiency via wrist based actigraphy
Time frame: Pre- and post-4 weeks of MBLT or sham treatment
Sleep efficiency is defined by the total time asleep divided by total time spent in bed
1 secondary outcome
Self-reported sleep quality via the Pittsburgh Sleep Quality Index
Time frame: Pre- and post-4 weeks of MBLT or sham treatment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2026.
- 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.
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 and Post-traumatic Stress Disorder, 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 5 inclusion and 9 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: looking for participants now, as of the sponsor's last update on 29 Jun 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jonathan E Elliott, PhD ((503) 220-8262, jonathan.elliott@va.gov), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sleep Efficiency via wrist based actigraphy (time frame: Pre- and post-4 weeks of MBLT or sham treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 29 Jun 2026.