None listed
Conditions
Brief summary
This is a single-centre, prospective post-market study using a TGA approved Class IIa medical device (“eMotion Faros Sensor”), which records electrocardiogram (ECG) through Kaoskey’s prototyped developed software suite (“TRIO”). Adult (18 years or older) participants admitted for inpatient video-EEG monitoring at The Alfred Hospital meeting eligibility criteria will be invited to participate in the study. Enrolled participants will be asked to wear the eMotion Faros Sensor during the monitoring period. High-resolution ECG recordings will be recorded during the patient’s admission and assessed using the TRIO software suite.
Interventions
Enrolled in-patients in the Alfred Epilepsy Diagnostic Unit will be asked to wear the eMotion Faros Sensor during the monitoring period, which is a Class IIa medical device that records electrocardiogram (ECG).
It involves the participant wearing 3x5-cent sized sticky electrodes on chest for 24-hours, repeated for each of the 5 days they are in the clinic. with the ECG recorder attached to one of the electrodes.
The device will be administered by the Alfred research assistant assigned to the p
Enrolled in-patients in the Alfred Epilepsy Diagnostic Unit will be asked to wear the eMotion Faros Sensor during the monitoring period, which is a Class IIa medical device that records electrocardiogram (ECG). It involves the participant wearing 3x5-cent sized sticky electrodes on chest for 24-hours, repeated for each of the 5 days they are in the clinic. with the ECG recorder attached to one of the electrodes. The device will be administered by the Alfred research assistant assigned to the project. After the 5 days of this data has been recorded, the Faros sensor/recorder is removed and the 5 days of ECG recordings downloaded. The TRIO software will then be used to post-process these 5-day recordings and TRIO seizure scoring files generated for later comparison with the independent Alfred Hospital clinical seizure scoring of this same data.
Sponsors
Kaoskey Pty Ltd
Study design
Allocation
Non-randomised trial
Primary purpose
Diagnosis
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
• Is able to provide personally signed and dated informed consent to participate in the study before completing any study related procedures. • Male or female (aged 18 years or older). • Possible diagnosis of epilepsy and admitted for inpatient video-EEG monitoring.
Exclusion criteria
• History of a cardiac rhythm or conduction disorder.
Outcome results
None listed