Ignite Creation Date:
2024-05-06 @ 3:18 PM
Last Modification Date:
2024-10-26 @ 1:46 PM
Study NCT ID:
NCT04582149
Status:
COMPLETED
Last Update Posted:
2024-02-14
First Post:
2020-10-05
Brief Title:
Eye-Control Trial Wearable Eye-Tracking Device as Means of Communication
Sponsor:
Emory University
Organization:
Emory University
Study Overview
Official Title:
Wearable Eye-Tracking Device as Means of Communication in the Critically Ill and Mechanically Ventilated Patient
Status:
COMPLETED
Status Verified Date:
2024-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 yesno 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
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 yesno 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None