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

NCT ID: NCT04582149

Last Updated: 2025-09-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-05-19
• Study Completion Date: 2023-01-23

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.

Detailed Description

Critically ill patients, who are mechanically ventilated, suffer not only from their acute, potentially devastating illness, but also from the lack of ability to communicate in an effective manner. This is the direct result of the orotracheal tube or tracheostomy required for the mechanical ventilation, which does not allow speech to be produced. On top of the mechanical change in air flow, communication challenges result from sedation, neurological injuries (primary brain injury or secondary encephalopathy), and delirium.

Lack of communication can lead to increased frustration, anxiety, and overall psychological stress and could continue to the development of post-traumatic stress disorder (PTSD). On top of the subjective discomfort, the inability to communicate in an effective manner may impair medical care-for example, by failure to assess symptoms such as pain or breathing discomfort by behavioral cues only.

Currently, the solutions for communication deficits in mechanically ventilated patients are mainly using yes/no communication, attempting to write, and communication boards that allow people to point at defined pictures or letters. Recently, technological advancements led to incorporation of more sophisticated communication devices, proving the feasibility of an eye-tracking approach, for example.

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. This approach eliminates the need for calibration, as most eye-tracking devices that use a screen require, and is relatively easy to operate.

This study will assess the safety, tolerability, and ease of use of the EyeControl device.

Conditions

Acute Respiratory Failure Requiring Mechanical Ventilation

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

EyeControl Eye-tracking Device

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

Group Type: EXPERIMENTAL

EyeControl Eye-tracking Device

Intervention Type: 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.

Interventions

EyeControl Eye-tracking 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.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Eyefree Assisting Communication Ltd

INDUSTRY

Sponsor Role: collaborator

Emory University

OTHER

Sponsor Role: lead

Responsible Party

Ofer Sadan

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ofer Sadan, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Emory University

Locations

Emory University Hospital

Atlanta, Georgia, United States

Countries

United States

References

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. 2025 Sep 13;91:155259. doi: 10.1016/j.jcrc.2025.155259. Online ahead of print.

Reference Type: RESULT

PMID: 40946530 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

IRB00114955

Identifier Type: -

Identifier Source: org_study_id