Journal Article

Feasibility and acceptability for LION, a fully remote, randomized clinical trial within the VA for light therapy to improve sleep in Veterans with and without TBI: An MTBI2 sponsored protocol

Twamley, Elizabeth W., Powers, Katherine, Morasco, Benjamin J., Hildebrand, Andrea D., Keil, Allison T., McBride, Alisha A., Elliott, Jonathan E., Brewer, Jessica S., Ligman, Brittany R., Gill, Jessica M., Dengler, Bradley A., Bryant-Ekstrand, Mohini D., Sicard, Savanah J., O’Neil, Maya E., Nguyen, Thuan, Lim, Miranda M.

2025

Overview

Sleep-wake disturbances frequently present in Veterans with mild traumatic brain injury (mTBI). These TBI-related sleep impairments confer significant burden and commonly exacerbate other functional impairments. Therapies to improve sleep following mTBI are limited and studies in Veterans are even more scarce. In our previous pilot work, morning bright light therapy (MBLT) was found to be a feasible behavioral sleep intervention in Veterans with a history of mTBI; however, this was single-arm, open-label, and non-randomized, and therefore was not intended to establish efficacy. The present study, LION (light vs ion therapy) extends this preliminary work as a fully powered, sham-controlled, participant-masked randomized controlled trial (NCT03968874), implemented as fully remote within the VA (target n = 120 complete). Randomization at 2:1 allocation ratio to: 1) active: MBLT (n = 80), and 2) sham: deactivated negative ion generator (n = 40); each with identical engagement parameters (60-min duration; within 2-hrs of waking; daily over 28-day duration). Participant masking via deception balanced expectancy assumptions across arms. Outcome measures were assessed following a 14-day baseline (pre-intervention), following 28-days of device engagement (post-intervention), and 28-days after the post-intervention assessment (follow-up). Primary outcomes were sleep measures, including continuous wrist-based actigraphy, self-report, and daily sleep dairy entries. Secondary/exploratory outcomes included cognition, mood, quality of life, circadian rhythm via dim light melatonin onset, and biofluid-based biomarkers. Participant drop out occurred in <10% of those enrolled, incomplete/missing data was present in <15% of key outcome variables, and overall fidelity adherence to the intervention was >85%, collectively establishing feasibility and acceptability for MBLT in Veterans with mTBI.

• Publisher: Public Library of Science,Public Library of Science (PLoS)
• Subject: Acceptability / Adult / Biology and Life Sciences / Biomarkers / Brain Concussion - complications / Brain Concussion - therapy / Brain Injuries, Traumatic - complications / Brain Injuries, Traumatic - physiopathology / Brain Injuries, Traumatic - radiotherapy / Brain Injuries, Traumatic - therapy / Chronic pain / Circadian rhythms / Clinical trials / Cognition / Expectancy / Feasibility / Feasibility Studies / Female / Head injuries / Humans / Injury prevention / Insomnia / Intervention / Light / Light therapy / Male / Medicine and Health Sciences / Melatonin / Middle Aged / Missing data / Negative ions / Phototherapy / Phototherapy - methods / Physical Sciences / Pilot projects / Post traumatic stress disorder / Quality of life / Randomization / Remote Consultation / Research and Analysis Methods / Sleep / Sleep - physiology / Sleep and wakefulness / Sleep Wake Disorders - therapy / Social Sciences / Study Protocol / Target masking / Traumatic brain injury / United States / United States Department of Veterans Affairs / Veterans / Wrist