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History of Changes for Study: NCT03968874
Improving Sleep, Sleep-related Outcomes, and Biomarkers in Veterans
Latest version (submitted April 4, 2022) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 May 28, 2019 None (earliest Version on record)
2 March 9, 2021 Recruitment Status, Study Status, Study Description and Contacts/Locations
3 April 4, 2022 Study Status and Study Description
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Study NCT03968874
Submitted Date:  May 28, 2019 (v1)

Open or close this module Study Identification
Unique Protocol ID: MIRB #4268, eIRB #19411
Brief Title: Improving Sleep, Sleep-related Outcomes, and Biomarkers in Veterans
Official Title: Improving Sleep, Sleep-related Outcomes, and Biomarkers in Veterans
Secondary IDs:
Open or close this module Study Status
Record Verification: May 2019
Overall Status: Not yet recruiting
Study Start: August 1, 2019
Primary Completion: August 1, 2024 [Anticipated]
Study Completion: August 1, 2025 [Anticipated]
First Submitted: May 23, 2019
First Submitted that
Met QC Criteria:
May 28, 2019
First Posted: May 30, 2019 [Actual]
Last Update Submitted that
Met QC Criteria:
May 28, 2019
Last Update Posted: May 30, 2019 [Actual]
Open or close this module Sponsor/Collaborators
Sponsor: Portland VA Medical Center
Responsible Party: Principal Investigator
Investigator: Miranda M Lim
Official Title: Principal Investigator
Affiliation: Portland VA Medical Center
Collaborators: Center for Neuroscience and Regenerative Medicine (CNRM)
Open or close this module Oversight
U.S. FDA-regulated Drug: No
U.S. FDA-regulated Device: No
Data Monitoring: No
Open or close this module Study Description
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).

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.

Open or close this module Conditions
Conditions: Traumatic Brain Injury
Keywords: Veterans
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Treatment
Study Phase: Not Applicable
Interventional Study Model: Parallel Assignment
Number of Arms: 2
Masking: Single (Participant)
Allocation: Randomized
Enrollment: 300 [Anticipated]
Open or close this module Arms and Interventions
Arms Assigned Interventions
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.
Open or close this module Outcome Measures
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
Open or close this module Eligibility
Minimum Age: 18 Years
Maximum Age: 88 Years
Sex: All
Gender Based:
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
Open or close this module Contacts/Locations
Central Contact Person: Miranda Lim, MD, PhD
Telephone: 503-220-8262 Ext. 57404
Email: lmir@ohsu.edu
Study Officials: Miranda Lim, MD, PhD
Principal Investigator
Portland VA
Locations:
Open or close this module IPDSharing
Plan to Share IPD: Yes
All non-identifiable data will be made available to qualified researchers on request to the study PI.
Supporting Information:
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.
URL:
Open or close this module References
Citations:
Links:
Available IPD/Information:

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