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Improving Sleep, Sleep-related Outcomes, and Biomarkers in Veterans

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ClinicalTrials.gov Identifier: NCT03968874
Recruitment Status : Recruiting
First Posted : May 30, 2019
Last Update Posted : March 11, 2021
Sponsor:
Collaborator:
Center for Neuroscience and Regenerative Medicine (CNRM)
Information provided by (Responsible Party):
Miranda M Lim, Portland VA Medical Center

Brief Summary:

The primary purpose of this project is to determine the effect of morning bright light therapy (MBLT) on sleep in Veterans with traumatic brain injury (TBI). Secondarily, the project aims to identify blood-based brain biomarkers (BBBM) associated with sleep in Veterans.

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.


Condition or disease Intervention/treatment Phase
Traumatic Brain Injury Device: Light box therapy Device: Negative Ion Generator Not Applicable

Detailed Description:

This project will utilize a biobehavioral intervention to improve sleep and apply a novel approach to measuring biomarkers in Veterans with TBI. The investigators will use morning bright light therapy (MBLT) to improve sleep. MBLT acts through intrinsically photosensitive retinal ganglion cells and has pleiotropic effects on sleep, circadian rhythms, cognition, mood, and pain through activation of brain circuits.

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 sham (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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Improving Sleep, Sleep-related Outcomes, and Biomarkers in Veterans
Actual Study Start Date : August 1, 2019
Estimated Primary Completion Date : August 1, 2024
Estimated Study Completion Date : August 1, 2025

Arm Intervention/treatment
Experimental: 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.
Device: Light box therapy
The intervention is sitting in front of a lightbox for 1 hour in the morning upon waking up.

Sham Comparator: Negative Ion Generator
Commercially available negative ion generator. Subjects asked to use everyday for an hour for 4 weeks upon waking.
Device: Negative Ion Generator
The intervention is sitting in front of a modified negative ion generator for 1 hour in the morning upon waking up.




Primary Outcome Measures :
  1. Change in Insomnia Severity Index (ISI) [ Time Frame: Baseline; after 4 weeks of intervention; and 2 months after the end of intervention ]
    Measures self-reported insomnia severity; total score range = 0-28 (higher total score = worse insomnia)


Secondary Outcome Measures :
  1. Change in NFL, GFAP, UCH-L1, and total tau [ Time Frame: Baseline; after 4 weeks of intervention; and 2 months after the end of intervention ]
    Change in neurofilament light chain (NFL), glial fibrillary acidic protein (GFAP), ubiquitin carboxyl-terminal hydrolase L1 (UCH-L1), and total tau



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 88 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Veteran
  • English-speaking
  • Accessible by phone

Exclusion Criteria:

  • Decisional impairment
  • Macular degeneration
  • Bipolar disorder
  • Shift work
  • Currently using lightbox or negative ion generator

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03968874


Contacts
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Contact: Miranda Lim, MD, PhD 503-220-8262 ext 57404 lmir@ohsu.edu

Locations
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United States, Oregon
Portland VA Medical Center Recruiting
Portland, Oregon, United States, 97239
Contact: Miranda M Lim, MD, PhD       lmir@ohsu.edu   
Sponsors and Collaborators
Portland VA Medical Center
Center for Neuroscience and Regenerative Medicine (CNRM)
Investigators
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Principal Investigator: Miranda Lim, MD, PhD Portland VA
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Responsible Party: Miranda M Lim, Principal Investigator, Portland VA Medical Center
ClinicalTrials.gov Identifier: NCT03968874    
Other Study ID Numbers: MIRB #4268, eIRB #19411
First Posted: May 30, 2019    Key Record Dates
Last Update Posted: March 11, 2021
Last Verified: March 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: All non-identifiable data will be made available to qualified researchers on request to the study PI.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Analytic Code
Time Frame: Information will be sent as soon as is practical and will be available as long as the PI is available.
Access Criteria: Legitimate research agenda, including but not limited to request to double-check presented or published results and novel analyses.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Miranda M Lim, Portland VA Medical Center:
Veterans
Additional relevant MeSH terms:
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Brain Injuries
Brain Injuries, Traumatic
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System
Wounds and Injuries