Eye-Control Trial: Wearable Eye-Tracking Device as Means of Communication (NCT04582149) | Clinical Trial Compass
CompletedNot Applicable
Eye-Control Trial: Wearable Eye-Tracking Device as Means of Communication
United States30 participantsStarted 2021-05-19
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Number of Participants Who Succeeded in Operating the EyeControl Device
Timeframe: Up to Day 3
2
Time To Successful Operation of the EyeControl Device
Timeframe: Up to Day 3
3
Number of Participants Successfully Operating the EyeControl Device Per Attempt Day