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Active Not Recruiting
NCT03968874
Improving Sleep, Sleep-related Outcomes, and Biomarkers in Veterans
Conditions: Traumatic Brain Injury
Sex: All
Ages: 18 Years – 88 Years
Healthy volunteers: Yes
Phase: NA
Enrollment: 300
Sponsor: Portland VA Medical Center
Location: Portland VA Medical Center Portland Oregon
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.
Eligibility 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
Source: ClinicalTrials.gov (NCT03968874). StuddyBuddy aggregates publicly available trial information.
