Eye-Control Trial: Wearable Eye-Tracking Device as Means of Communication

NCT04582149 | Completed Results FDA Device

• 1 other identifier: IRB00114955
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate the feasibility of use of a wearable communication device for critically ill patients who are admitted to the intensive care unit (ICU) and mechanically ventilated. The study will assess the safety, tolerability, and ease of use of the EyeControl device, and examine its potential monitoring capabilities.

Conditions

Acute Respiratory Failure Requiring Mechanical Ventilation

Keywords

Critical illness; Communication; Intensive care unit; Mechanical ventilation

Outcome Measures

Primary Outcomes (3)

• Number of Participants Who Succeeded in Operating the EyeControl Device

  Successful operation of the device was defined as completing a set of assignments termed as a proficiency test. This proficiency test included the ability to call for help and the ability to choose a correct answer out of multiple choice questions that were read to the patient using the device. Participants were able to try to learn to operate the device once per day for up to three days.

  Up to Day 3

• Time To Successful Operation of the EyeControl Device

  Successful operation of the device was defined as completing a set of assignments termed as a proficiency test. This proficiency test included the ability to call for help and the ability to choose a correct answer out of multiple choice questions that were read to the patient using the device. Participants were able to try to learn to operate the device once per day for up to three days. The time (in minutes) of training required for a patient to successfully operate the device was documented.

  Up to Day 3

• Number of Participants Successfully Operating the EyeControl Device Per Attempt Day

  Successful operation of the device was defined as completing a set of assignments termed as a proficiency test. This proficiency test included the ability to call for help and the ability to choose a correct answer out of multiple choice questions that were read to the patient using the device. Participants were able to try to learn to operate the device once per day for up to three days. The study day when participants passed the proficiency test was documented.

  Up to Day 3

Secondary Outcomes (1)

• Days of Use

  Up to end of study participation (up to 3 days)

Study Arms (1)

EyeControl Eye-tracking Device

EXPERIMENTAL

Ventilated ICU patients using the EyeControl wearable, eye-tracking device.

Device: EyeControl Eye-tracking Device

Interventions

EyeControl Eye-tracking Device DEVICE

The EyeControl is a new, wearable, eye-tracking device that facilitates communication by means of internal feedback to the patients with a bone-conducting speaker. In this way, the device can ask the patient what he or she wants to say, and the patient replies by eye gestures such as blinking or moving the eyes in a certain direction. Once the patient is able to operate the device, it will stay on the patient for as long as she or he would like it on, or until the patient is successfully extubated or discharged from the ICU, whichever is earliest.

EyeControl Eye-tracking Device

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Intensive Care Unit (ICU) Admission
• Mechanically ventilated for at least 24 hours
• Richmond Agitation Sedation Score (RASS) between -1 to 1 at the time of screening
• Ability to follow simple commands

You may not qualify if:

• Inability to follow commands during screening (at a minimum: open and close eyes, move eyes to one side or the other)
• Known cerebral injury (acute or chronic) in the dominant hemisphere concerning for aphasia on clinical assessment
• Significant pre-existing neurologic (i.e., dementia and/or cognitive deficiencies), psychiatric, or baseline communication challenges that would confound outcomes assessments
• Inability to blink or move eyes for any reason
• Prisoner or incarceration
• Inability or unwillingness to provide informed consent
• Unwillingness to be contacted for follow-up

Sponsors & Collaborators

• Emory University: lead
• Eyefree Assisting Communication Ltd: collaborator

Study Sites (1)

Emory University Hospital

Atlanta, Georgia, 30322, United States

Location

Related Publications (1)

• Sadan O, Ratcliff JJ, Samuels OB, Hall AJ. A pilot study to assess the safety and feasibility of a wearable communication device in mechanically ventilated critically ill patients. J Crit Care. 2026 Feb;91:155259. doi: 10.1016/j.jcrc.2025.155259. Epub 2025 Sep 13.

  PMID: 40946530 RESULT

MeSH Terms

Conditions

Critical Illness; Communication

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Behavior

Results Point of Contact

• Title: Ofer Sadan, MD, PhD
• Organization: Emory University

ofer.sadan@emory.edu

470-480-6956

Study Officials

• Ofer Sadan, MD, PhD

  Emory University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: October 5, 2020
• First Posted: October 9, 2020
• Study Start: May 19, 2021
• Primary Completion: January 23, 2023
• Study Completion: January 23, 2023
• Last Updated: September 25, 2025
• Results First Posted: February 14, 2024

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Individual participant data will be available for sharing beginning one year after article publication, with no end date.
• Access Criteria: Non-study investigators and researchers (i.e., external) may submit their proposal to the study investigators for approval of methodologically appropriate proposals and inquiry. Data will be available for sharing in order to achieve aims in the approved proposal. Proposals should be submitted to the PI at ofer.sadan@emory.edu. Requestors will be required to execute a data use/transfer agreement to receive a limited dataset. Data will be provided directly to external investigators.

Locations

US (1)