Eyecontrol coMmunication Platform for dEliRium manaGemEnt in Intensive Care Units (EMERGE)

Beth Israel Lahey Health

Status: Completed

Conditions: Delirium; Critical Illness; Intensive Care Unit Delirium; Delirium in Old Age

Treatments: Device: EyeControl-Pro; Other: Control

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT06029244

2023P000563

Details and patient eligibility

About

The purpose of this research is to investigate whether addition of the EyeControl-Pro platform as an adjunct to standard guideline-based intensive care unit management of critically ill patients is effective in reducing delirium incidence and severity.

Full description

This is a prospective, binational, single-blind, multicenter, randomized control trial, conducted according to international good clinical practice (GCP) ethical and quality standards. Critically ill, mechanically ventilated patients aged >=50 years with Richmond Agitation Sedation Scale (RASS) score of -3 to +1 (at time of screening) who are anticipated to require ventilation for >=24 hours will be eligible for recruitment. The study will be conducted simultaneously at Beth Israel Deaconess Medical Center (BIDMC) Boston, USA, Assuta Ashdod Medical Center (Ashdod, Israel) and Rabin Medical Center (Petah Tikvah, Israel) with BIDMC contributing up to 50% of the total enrollment. Participants will be randomized to either a) sham device or b) active intervention arm (details described below). Legally appointed representatives, patients and caregiver teams will be administered an optional questionnaire to assess their experience with the study device at the conclusion of the study protocol. Study subjects will be administered the telephone-Montreal Cognitive Assessment (t-MoCA); total score of 22 - missing 8 points present in Montreal Cognitive Assessment (MoCA) pertaining to drawing/executive function not feasible over phone) or MoCA (if still in-hospital; assessed out of total score of 30) and Hospital Anxiety and Depression Scale (HADS) questionnaire 30 days post-randomization. Hebrew versions of these questionnaires will be used at Israeli sites.

Enrollment: 160 patients

Sex: All

Ages: 50+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Mechanically ventilated patients aged >=50 years
• RASS score of -3 to +1 and
• Anticipated to require >=24 hours of mechanical ventilation

Exclusion criteria

• Not expected to survive >=24 hours
• Have limitations in care (Do Not Resuscitate, or comfort-focused care orders)
• Receiving paralytic neuromuscular blocking agent (NMBA) infusion or anticipated need for NMBA use
• Have advanced dementia or cognitive impairment including post-concussive syndrome.
• Have severe uncorrected psychiatric disorders.
• Have uncorrected hearing or visual impairment.
• Acute or subacute neurological disorder hindering communication or ability to participate in CAM ICU assessments
• Enrolled in a clinical trial which prohibits co-enrollment.
• Incarcerated
• Have no identified legally appointed representative (LAR)
• Are unable to communicate in the predominant local language (English at US site and English/Hebrew/Arabic/Russian in Israel)
• Refusal of treating clinical team.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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160 participants in 2 patient groups

EyeControl-Pro assisted active intervention arm

Active Comparator group

Description:

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.

Treatment:

Device: EyeControl-Pro

Sham Control

Sham Comparator group

Description:

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.

Treatment:

Other: Control