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

  • STATUS
    Recruiting
  • End date
    Apr 3, 2023
  • participants needed
    60
  • sponsor
    Emory University
Updated on 3 May 2022

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.

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.

Details
Condition Acute Respiratory Failure Requiring Mechanical Ventilation
Treatment EyeControl Eye-tracking Device
Clinical Study IdentifierNCT04582149
SponsorEmory University
Last Modified on3 May 2022

Eligibility

Yes No Not Sure

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
Clear my responses

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  • You can expect the study team to contact you via email or phone in the next few days.
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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