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

November 26, 2025 updated by: Somnath Bose, MD, Beth Israel Deaconess Medical Center

Eyecontrol coMmunication Platform for dEliRium manaGemEnt in Intensive Care Units (EMERGE) : A Multicenter Randomized Controlled Trial

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Actual)

160

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Israel
      • Ashdod, Israel
        • Assuta Ashdod Medical Center
      • Petah Tikva, Israel
        • Rabin Medical Center
  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Beth Israel Deaconess Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: EyeControl-Pro assisted active intervention arm
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.
Device: EyeControl-Pro
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
Sham Comparator: Sham Control
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.
Other: Control
No intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Prevalence of any delirium occurrence defined as CAM ICU 7 score (>=2) during the first 7 days in ICU post-randomization or ICU discharge/death (whichever is sooner)
Time Frame: Upto 7 days or liberation from ventilator whichever is sooner.
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.
Upto 7 days or liberation from ventilator whichever is sooner.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Prevalence of severe delirium assessments (defined as CAM ICU 7>=6) during the first 7 days in ICU post-randomization or ICU discharge/death (whichever is sooner)
Time Frame: Upto 7 days or discharge from intensive care unit (ICU) whichever is sooner
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.
Upto 7 days or discharge from intensive care unit (ICU) whichever is sooner
Mean number of days with delirium (defined as the total number of days with at least one CAM ICU 7 positive delirium assessment within 7 days post-randomization or up to discharge from the ICU/death, whatever occurs earlier.
Time Frame: Upto 7 days or discharge from intensive care unit (ICU) whichever is sooner
To evaluate if subjects randomized to the active EyeControl-Pro arm have lower delirium incidence (as measured by CAM-ICU) within first 7 days post randomization or ICU discharge whichever is sooner when compared to sham EyeControl-Pro arm.
Upto 7 days or discharge from intensive care unit (ICU) whichever is sooner

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
ICU days alive and free of delirium and coma
Time Frame: Upto 7 days or discharge from intensive care unit (ICU) whichever is sooner
To evaluate if subjects randomized to the active EyeControl-Pro arm have higher number of days free of coma and delirium within first 7 days post randomization or ICU discharge whichever is sooner when compared to sham EyeControl-Pro arm
Upto 7 days or discharge from intensive care unit (ICU) whichever is sooner
Cognitive scores
Time Frame: 30 days post-randomization.
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.
30 days post-randomization.
Depression anxiety scores
Time Frame: 30 days post-randomization.
To compare depression and anxiety scores at 30 days post enrollment using the HADS (Hospital Anxiety and Depression Scale) questionnaire.HADS ranges from 0-21 with higher scores indicating worse depression or anxiety
30 days post-randomization.
CAM ICU concordance
Time Frame: During device usage upto 7 days
Agreement between CAM ICU assessment between Eyecontrol and investigator administered CAM-ICU in active intervention arm
During device usage upto 7 days
Days free of restraints
Time Frame: Upto 7 days or discharge from intensive care unit
Comparison of days free of restraints between 2 groups
Upto 7 days or discharge from intensive care unit
Use of rescue medications for delirium and agitation
Time Frame: Upto 7 days or discharge from intensive care unit
Use of medications for agitated delirium
Upto 7 days or discharge from intensive care unit

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Beth Israel Deaconess Medical Center

Collaborators

Rabin Medical Center
Assuta Medical Center
Eyefree Assisting Communication Ltd
BIRD (Israel-United States Binational Industrial Research and Development) Foundation- Funding agency

Investigators

  • Principal Investigator: Somnath Bose, MD, Beth Israel Deaconess Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 25, 2024

Primary Completion (Actual)

October 20, 2025

Study Completion (Actual)

November 18, 2025

Study Registration Dates

First Submitted

September 1, 2023

First Submitted That Met QC Criteria

September 1, 2023

First Posted (Actual)

September 8, 2023

Study Record Updates

Last Update Posted (Estimated)

December 3, 2025

Last Update Submitted That Met QC Criteria

November 26, 2025

Last Verified

November 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2023P000563

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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