Improving Sleep, Sleep-related Outcomes, and Biomarkers in Veterans
NCT ID: NCT03968874
Last Updated: 2025-11-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
NA
300 participants
INTERVENTIONAL
2019-08-01
2025-12-01
Brief Summary
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Specific Aim 1. Determine the effect of MBLT on sleep quality in Veterans (primary outcome).
Specific Aim 2. Determine the effect of MBLT on downstream effectors of improved sleep, including cognition, mood, and quality of life measures in Veterans (exploratory outcomes).
Specific Aim 3. Determine the effect of MBLT on levels of specific BBBM related to sleep, and whether changes in specific BBBM predict response to MBLT (secondary outcome).
This study can now be completed 100% remotely.
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Detailed Description
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MBLT is a simple, cost-effective, home-based sleep intervention. It has been studied in a variety of neuropsychiatric populations, such as seasonal affective disorder, non-seasonal depression, Alzheimer's, Huntington's, Parkinson's disease, and schizophrenia. MBLT is an attractive intervention for TBI as patients typically report multiple concomitant symptoms including alterations in mood and alertness (daytime fatigue). One recent placebo-controlled study using MBLT reported improved fatigue in individuals with TBI. Moreover, MBLT has high patient acceptability and is scalable, owing to its ability to be rapidly implemented in any setting including in the home or in a rehabilitation facility.
To address the substantial limitation of using peripheral biomarkers to understand central pathophysiology in TBI, the investigators have developed a method to use blood-based brain biomarkers (BBBM) to track central pathophysiology and symptomatology of TBI and response to treatment. This method entails isolation of neuronally derived exosomes in peripheral blood. Exosomes are membrane bound structures that, instead of being delivered to lysosomes for destruction, reside in multivesicular bodies, fuse with the plasma membrane, and are exocytosed into extracellular spaces. Within the membrane of exosomes are various proteins present in the cell of origin; thus, the cargo of exosomes reflects the microenvironment from the site of exosome production. Exosomes hold promise in TBI since they can readily cross the blood brain barrier (BBB) and be isolated from peripheral circulation. Studying exosomes allows us to isolate those proteins that are routinely disrupted in patients with TBI and sleep disturbances, and to track changes in accordance with treatment condition over time.
In this project, the investigators will conduct a randomized controlled, single blinded trial in which Veterans with and without TBI will receive MBLT or modified negative ion generator; (see below for modification specifications) for 4-weeks. BBBM will be assessed in conjunction with MBLT/sham and neurobehavioral symptomatology. The investigators hypothesize that: 1) MBLT will be associated with improved sleep, and downstream effectors of improved sleep (i.e., cognition, mood, and quality of life), compared to the sham condition; 2) MBLT will show a correlation between BBBM and improved sleep, and levels of BBBM will predict those that respond to MBLT. This will provide novel insights into how these biomarkers relate to neuronal and behavioral changes following TBI and may inform trajectory of recovery.
The study can be completed 100% remotely, in person, or a combination of the two.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Light box
Commercially available lightbox emitting 10,000 lux of light. Subjects asked to use lightbox everyday for an hour for 4 weeks upon waking.
Light box therapy
The intervention is sitting in front of a lightbox for 1 hour in the morning upon waking up.
Negative Ion Generator
Commercially available negative ion generator. Subjects asked to use everyday for an hour for 4 weeks upon waking.
Negative Ion Generator
The intervention is sitting in front of a modified negative ion generator for 1 hour in the morning upon waking up.
Interventions
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Light box therapy
The intervention is sitting in front of a lightbox for 1 hour in the morning upon waking up.
Negative Ion Generator
The intervention is sitting in front of a modified negative ion generator for 1 hour in the morning upon waking up.
Eligibility Criteria
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Inclusion Criteria
* English-speaking
* Accessible by phone
Exclusion Criteria
* Macular degeneration
* Bipolar disorder
* Shift work
* Currently using lightbox or negative ion generator
18 Years
88 Years
ALL
Yes
Sponsors
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Center for Neuroscience and Regenerative Medicine (CNRM)
FED
Portland VA Medical Center
FED
Responsible Party
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Miranda M Lim
Principal Investigator
Principal Investigators
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Miranda Lim, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Portland VA
Locations
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Portland VA Medical Center
Portland, Oregon, United States
Countries
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Other Identifiers
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MIRB #4268, eIRB #19411
Identifier Type: -
Identifier Source: org_study_id
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