Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12620000600943
Ethics application status
Approved
Date submitted
2/03/2020
Date registered
25/05/2020
Date last updated
25/05/2020
Date data sharing statement initially provided
25/05/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
Seizure Detection Using Kaoskey TRIO Software
Scientific title
Seizure Detection Using Electrocardiogram Recordings and Kaoskey TRIO Software among participants admitted for inpatient video-EEG monitoring
Secondary ID [1] 300699 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Epilepsy 316512 0
Condition category
Condition code
Neurological 314755 314755 0 0
Epilepsy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 317022 0
Diagnosis / Prognosis
Comparator / control treatment
There is currently no device on the market that accurately automatically detects epileptic seizures, especially those that are non-convulsive ('absence seizures').
Video-EEG:
The gold standard throughout the world for seizure diagnosis is manual post-processing of video-EEG monitoring recordings, which will be the comparator in this study.

The video-EEG patient data is collected by setting up continuous recording of 16 channels of EEG from a patient skull cap, and of a continuos video of the patient, for the 5 days the patients are in the clinic.

In this current video-EEG seizure scoring procedure, after the data has been recorded a highly trained clinical specialist scrolls through simultaneous displays of the patient video and 16 channels of EEG to decide when seizures have occurred. This procedure typically takes ~8 hours to score 4-5 days of patient video-EEG data.

The TRIO software analysis of the FAROS 5 days of ECG recording is similarly post-processed at the end of the 5 days.
Control group
Active

Outcomes
Primary outcome [1] 323594 0
Seizure events as assessed by high-resolution ECG recordings with the “TRIO” software and with Alfred Video-EEG to be compared to provide false positive / false negative assessment of TRIO performance versus the current clinical standard.
Timepoint [1] 323594 0
Data will be collected during the five-day inpatient video-EEG monitoring period.
Secondary outcome [1] 382694 0
The quality of ECG recordings from the compact 2-channel chest-mounted sensor for seizure detection, assessed by sufficient performance of the "TRIO" software.
Timepoint [1] 382694 0
Data will be collected during the five-day inpatient video-EEG monitoring period.

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• History of a cardiac rhythm or conduction disorder.

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis
The TRIO software processes blinded 5-day ECG recordings and provides a list of ’events’ with their start time, end time, duration, and the maximum value of the TRIO index of cardiac disorder (ICD). This TRIO ‘events’ list is then sent to The Alfred Epilepsy Clinic where the TRIO events are compared with their Video-EEG scoring of seizures for the same patient. The false positive and false negative rates for the TRIO scoring are then calculated.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/06/2020
Actual
Date of last participant enrolment
Anticipated
31/01/2021
Actual
Date of last data collection
Anticipated
28/02/2021
Actual
Sample size
Target
100
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 16053 0
The Alfred - Melbourne
Recruitment postcode(s) [1] 29565 0
3004 - Melbourne

Funding & Sponsors
Funding source category [1] 305142 0
Commercial sector/Industry
Name [1] 305142 0
Kaoskey Pty Ltd
Country [1] 305142 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Kaoskey Pty Ltd
Address
Unit 6, 3 Central Ave,
Thornleigh, NSW 2120
Country
Australia
Secondary sponsor category [1] 305501 0
None
Name [1] 305501 0
Address [1] 305501 0
Country [1] 305501 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 305510 0
Alfred Hospital Human Research Ethics Committee
Ethics committee address [1] 305510 0
The Alfred Hospital
55 Commercial Road
Melbourne, VIC3004
Ethics committee country [1] 305510 0
Australia
Date submitted for ethics approval [1] 305510 0
04/03/2020
Approval date [1] 305510 0
24/04/2020
Ethics approval number [1] 305510 0
HREC/61886/Alfred-2020

Summary
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.
Trial website
n/a
Trial related presentations / publications
n/a
Public notes

Contacts
Principal investigator
Name 100618 0
Prof Professor Terence J. O’Brien
Address 100618 0
Department of Neurology Level 4 (Central Block)
The Alfred Hospital 55 Commercial Road Melbourne, VIC 3004
Country 100618 0
Australia
Phone 100618 0
+61 0479 041 282
Fax 100618 0
Email 100618 0
[email protected]
Contact person for public queries
Name 100619 0
Prof Professor Terence J. O’Brien/Dr Shobi Sivathamboo
Address 100619 0
Department of Neurology Level 4 (Central Block)
The Alfred Hospital 55 Commercial Road Melbourne, VIC 3004
Country 100619 0
Australia
Phone 100619 0
+61 0479 041 282
Fax 100619 0
Email 100619 0
[email protected]
Contact person for scientific queries
Name 100620 0
Prof Professor Terence J. O’Brien/Dr Shobi Sivathamboo
Address 100620 0
Department of Neurology Level 4 (Central Block)
The Alfred Hospital 55 Commercial Road Melbourne, VIC 3004
Country 100620 0
Australia
Phone 100620 0
+61 0479 041 282
Fax 100620 0
Email 100620 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
7199Informed consent form    379390-(Uploaded-24-04-2020-15-50-09)-Study-related document.docx



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.