Clinical Trial

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

Active, Not Recruiting
View on ClinicalTrials.gov →
Record status
This record was last updated November 14, 2025 (before its estimated December 1, 2025 completion). Its status may not reflect the trial's current state.
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.
Protocol Amendment History 3 amendments
This ClinicalTrials.gov record has been amended 3 times since 2019-05-28; most recent amendment 2025-11-12.
Status change: Recruiting → Active, Not Recruiting 2025-11-12
Status change: Not Yet Recruiting → Recruiting 2021-03-09
Trial Details
NCT Number NCT03968874
Lead Sponsor Portland VA Medical Center
Collaborators: Center for Neuroscience and Regenerative Medicine (CNRM)
Conditions Traumatic Brain Injury
Enrollment 300 participants
Start Date 2019-08-01
Primary Completion 2025-12-01 (estimated)
Study Completion 2025-12-01 (estimated)
Updated on ClinicalTrials.gov 2025-11-14