Participants will wear the EyeControl-Pro device daily from 08:00-18:00 (extendable to 20:00; minimum 4 hours for compliance). On Day 1, onboarding includes a ≤2 min auditory tutorial, repeated daily for orientation. The device delivers up to 5 personalized family messages and 5 automated re-orientation messages per day, alternating approximately every 2 hours to maintain engagement and awareness. Slow-tempo music or white/brown noise plays in 15-minute sessions every 4 hours, modulated according to the patient's preferences and responses. The device performs twice-daily automated CAM-ICU assessments, scheduled within 45 minutes of blinded assessor CAM-ICU to allow comparison. Study team delirium assessments occur twice daily through Day 7, then once daily if in ICU for days 8-14, with MoCA/t-MoCA and HADS at Day 30 (+14 day window). Device use ends after 7 days, earlier if extubated, discharged, transitioned to comfort care, or in the event of death.

Participants will wear an identical-appearing EyeControl device daily from 08:00-18:00 (extendable to 20:00; minimum 4 hours for compliance). On Day 1, onboarding includes a ≤2 min auditory tutorial introducing the device. No automated re-orientation messages, family messages, or music sessions are delivered. The device tracks eye state and logs activity but does not provide auditory feedback beyond the initial tutorial. Blinded study team members perform twice-daily CAM-ICU and CAM-ICU-7 assessments through Day 7, then once daily if in ICU for days 8-14. MoCA/t-MoCA and HADS assessments occur at Day 30 (+14 day window). Device is removed after 7 days, upon extubation, ICU discharge, comfort care transition, or death.

Based on artificial intelligence (AI)-powered eye-tracking technology, the EyeControl-Pro wearable device and smart platform enable 24/7 customizable communication and monitoring between ventilated patients who cannot speak, their families, and medical teams

To evaluate if study subjects randomized to active EyeControl-Pro arm have a higher proportion of delirium free assessments as assessed by CAM (confusion assessment method)-ICU 7 during device usage for up to 7 days when compared with those in the sham EyeControl-Pro arm. CAM-ICU is a validated assessment tool for detection of ICU delirium.

To evaluate if study subjects in the active EyeControl-Pro arm have lower prevalence of severe delirium assessments as measured by CAM-ICU7 within first 7 days post randomization or ICU discharge (whichever is sooner) when compared to sham control arm. CAM-ICU 7 is a validated instrument for measurement of delirium severity with scores ranging from 0-7.

To compare cognitive function at 30 days post enrollment using the t-MoCA (telephone-Montreal Cognitive Assessment) or MoCA (if still in-hospital) questionnaire. MoCA is a validated instrument for assessment of cognition with range 0-30 (0-22 for telephonic version) score of over 26 indicates normal.