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

NCT06029244 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 160

Last updated 2025-12-03

No results posted yet for this study

Summary

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.

Conditions

  • Delirium
  • Delirium in Old Age
  • Critical Illness
  • Intensive Care Unit Delirium

Interventions

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

OTHER

Control

No intervention

Sponsors & Collaborators

  • BIRD (Israel-United States Binational Industrial Research and Development) Foundation- Funding agency

    collaborator UNKNOWN

  • Rabin Medical Center

    collaborator OTHER

  • Assuta Medical Center

    collaborator OTHER

  • Eyefree Assisting Communication Ltd

    collaborator INDUSTRY

  • Beth Israel Deaconess Medical Center

    lead OTHER

Principal Investigators

  • Somnath Bose, MD · Beth Israel Deaconess Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-02-25
Primary Completion
2025-10-20
Completion
2025-11-18
FDA Device
Yes

Countries

  • United States
  • Israel

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06029244 on ClinicalTrials.gov