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

NCT03968874 | Active Not Recruiting

• 1 other identifier: MIRB #4268, eIRB #19411
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

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.

Conditions

Traumatic Brain Injury

Keywords

Veterans

Outcome Measures

Primary Outcomes (1)

• Change in Insomnia Severity Index (ISI)

  Measures self-reported insomnia severity; total score range = 0-28 (higher total score = worse insomnia)

  Baseline; after 4 weeks of intervention; and 2 months after the end of intervention

Secondary Outcomes (1)

• Change in NFL, GFAP, UCH-L1, and total tau

  Baseline; after 4 weeks of intervention; and 2 months after the end of intervention

Study Arms (2)

Light box

EXPERIMENTAL

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

Negative Ion Generator

SHAM COMPARATOR

Commercially available negative ion generator. Subjects asked to use everyday for an hour for 4 weeks upon waking.

Device: Negative Ion Generator

Interventions

Light box therapy DEVICE

The intervention is sitting in front of a lightbox for 1 hour in the morning upon waking up.

Light box

Negative Ion Generator DEVICE

The intervention is sitting in front of a modified negative ion generator for 1 hour in the morning upon waking up.

Negative Ion Generator

Eligibility Criteria

• Age: 18 Years - 88 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Veteran
• English-speaking
• Accessible by phone

You may not qualify if:

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

Sponsors & Collaborators

• Portland VA Medical Center: lead
• Center for Neuroscience and Regenerative Medicine (CNRM): collaborator

Study Sites (1)

Portland VA Medical Center

Portland, Oregon, 97239, United States

Location

MeSH Terms

Conditions

Brain Injuries, Traumatic

Condition Hierarchy (Ancestors)

Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries

Study Officials

• Miranda Lim, MD, PhD

  Portland VA

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 23, 2019
• First Posted: May 30, 2019
• Study Start: August 1, 2019
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: November 14, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, 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.

Locations

US (1)