NCT04582149

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

Completed NA Results posted Last updated 25 September 2025

What this trial tests

NA trial testing EyeControl Eye-tracking Device in Acute Respiratory Failure Requiring Mechanical Ventilation in 30 participants. Completed in 23 January 2023.

Timeline

19 May 2021

Primary endpoint
23 January 2023

23 January 2023

Quick facts

Lead sponsor	Emory University
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	supportive care
Enrollment	30
Start date	19 May 2021
Primary completion	23 January 2023
Estimated completion	23 January 2023
Sites	1 location across United States

Drugs / interventions tested

• EyeControl Eye-tracking Device

Conditions studied

• Acute Respiratory Failure Requiring Mechanical Ventilation — all drugs for Acute Respiratory Failure Requiring Mechanical Ventilation →

Sponsor

Emory University

Who can join

18 and older, any sex, with Acute Respiratory Failure Requiring Mechanical Ventilation. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Number of Participants Who Succeeded in Operating the EyeControl Device Primary · Up to Day 3

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.

Group	Value	95% CI
EyeControl Eye-tracking Device	11

Time To Successful Operation of the EyeControl Device Primary · Up to Day 3

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.

Group	Value	95% CI
EyeControl Eye-tracking Device	11	± 3

Number of Participants Successfully Operating the EyeControl Device Per Attempt Day Primary · Up to Day 3

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.

Group	Value	95% CI
EyeControl Eye-tracking Device	8
EyeControl Eye-tracking Device	3
EyeControl Eye-tracking Device	0

Days of Use Secondary · Up to end of study participation (up to 3 days)

The duration of EyeControl device use and participation in the trial was recorded in days (participation in the trial ended when use of the device ended). Participants left the trial due to inability to operate the device, patient request, technical issues, and no longer needing the device (extubation, ICU discharge).

Group	Value	95% CI
EyeControl Eye-tracking Device	1	1 – 3

Clinical Characteristics of Participants Who Passed or Did Not Pass The Proficiency Test Secondary · Up to Day 3

Participants were stratified based on whether or not they passed the proficiency test and were able to successfully operate the EyeControl device. Clinical characteristics (tracheostomy, delirium, and exposure to certain medications) of these groups of participants were examined.

Tracheostomy

Group	Value	95% CI
Passed Proficiency Test	3
Did Not Pass Proficiency Test	8

Delirium detected on day of device use

Group	Value	95% CI
Passed Proficiency Test	1
Did Not Pass Proficiency Test	3

Exposure to fentanyl on day of attempt to use device

Group	Value	95% CI
Passed Proficiency Test	2
Did Not Pass Proficiency Test	6

Exposure to any benzodiazepine on day of attempt to use device

Group	Value	95% CI
Passed Proficiency Test	0
Did Not Pass Proficiency Test	1

Exposure to dexmedetomidine on day of attempt to use device

Group	Value	95% CI
Passed Proficiency Test	6
Did Not Pass Proficiency Test	7

Exposure to propofol on day of attempt to use device

Group	Value	95% CI
Passed Proficiency Test	0
Did Not Pass Proficiency Test	2

Exposure to any pressors on day of attempt to use device

Group	Value	95% CI
Passed Proficiency Test	4
Did Not Pass Proficiency Test	3

SOFA Score of Participants Who Passed or Did Not Pass The Proficiency Test Secondary · Up to Day 3

Participants were stratified based on whether or not they passed the proficiency test and were able to successfully operate the EyeControl device. The Sequential Organ Failure Assessment (SOFA) Score at admission of these groups of participants was compared. The SOFA score is a mortality prediction score that is based on the degree of dysfunction of 6 organ systems (respiratory, nervous, cardiovascular, liver, coagulation, and kidneys). Each organ system is scored on a 5-point scale where normal = 0 and high degree of disfunction = 4. The total score ranges from 0 to 24 and a higher score indi

Group	Value	95% CI
Passed Proficiency Test	7	0 – 15
Did Not Pass Proficiency Test	4	0 – 15

Age of Participants Who Passed or Did Not Pass The Proficiency Test Secondary · Up to Day 3

Participants were stratified based on whether or not they passed the proficiency test and were able to successfully operate the EyeControl device. The mean age at admission of these groups of participants was compared.

Group	Value	95% CI
Passed Proficiency Test	51.9	± 15.2
Did Not Pass Proficiency Test	50.4	± 14.8

Adverse events — posted to ClinicalTrials.gov

Time frame: Information on adverse events was collected beginning at the time patients gave consent to participate and continued up to extubation, ICU discharge, or when the participant wanted to stop using the device (up to 3 days).. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

EyeControl Eye-tracking Device

Serious: 0/30 (0%)

Deaths: 0/30

Other adverse events (1 terms — click to expand)

Reaction	System	EyeControl Eye-tracking De…
Transient redness of the skin where device touches the skin	Skin and subcutaneous tissue disorders	—

Data from ClinicalTrials.gov NCT04582149 adverse events section.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.