EyeControl Communication Platform for Delirium Management in ICUs

Background Delirium is common among patients using mechanical ventilation in ICUs and is associated with prolonged hospitalization, increased health care costs, and long-term cognitive decline. Nonpharmacologic interventions have shown promise in mitigating delirium, but face implementation challenges. Research Question Can EyeControl-Pro (EyeControl Co.), a novel, noninvasive communication platform, reduce delirium burden among older patients using mechanical ventilation in the ICU compared with a sham-control device? Study Design and Methods This is a multicenter, prospective, single-masked, randomized controlled trial conducted across 3 hospitals in the United States and Israel. Patients using mechanical ventilation 50 years of age or older with a Richmond Agitation-Sedation Scale score of between –3 and +1 and expected to require ≥ 24 hours of ventilation are enrolled. Participants are randomized (1:1) to either an active EyeControl-Pro device or a sham-control arm. The active device delivers orientation prompts, personalized music, and recorded family messages; the sham device provides only an initial instructional message. Delirium is assessed twice daily using the Confusion Assessment Method for the ICU 7 (CAM-ICU-7) tool for up to 7 days, then once daily until day 14 or ICU discharge. A 30-day after enrollment follow-up assesses cognitive and psychological function using the Montreal Cognitive Assessment and Hospital Anxiety and Depression Scale. The primary outcome is any occurrence of delirium per patient, measured using the CAM-ICU-7 tool. Secondary outcomes include severity of delirium and the total number of days with delirium. Results Trial recruitment and data collection are ongoing. Interpretation This trial explores whether the EyeControl-Pro can reduce ICU delirium through enhanced communication among older patients using mechanical ventilation. If effective, it may provide a scalable, nonpharmacologic strategy to improve outcomes in critically ill patients. Clinical Trial Registration ClinicalTrials.gov; No.: NCT06029244; URL: www.clinicaltrials.gov