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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.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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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
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
  • 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

    Recruiting

Other trials in United States

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 groups in NCT06477796
Study groupRoleWhat they receive
Morning Bright Light TherapyExperimentalMorning 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 GeneratorSham comparatorNegative 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.

  1. 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)
  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.

  1. First posted27 Jun 2024
  2. Study start1 May 2025
  3. Primary completion1 Dec 2027 (estimated)
  4. Study completion29 Sep 2028 (estimated)

Resources

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)
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

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.

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