Ignite Creation Date:
2024-05-06 @ 6:39 PM
Last Modification Date:
2024-10-26 @ 2:52 PM
Study NCT ID:
NCT05738226
Status:
RECRUITING
Last Update Posted:
2023-02-22
First Post:
2023-02-01
Brief Title:
EpiCareHome Validation Study for Focal Onset Seizures
Sponsor:
Byteflies
Organization:
Byteflies
Study Overview
Official Title:
Validation Study for Monitoring of Focal Onset Epileptic Seizures With a Wearable Seizure Monitoring Device EpiCareHome
Status:
RECRUITING
Status Verified Date:
2023-02
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 goal of this clinical trial is to validate a wearable seizure monitoring device EpiCareHome as an objective seizure monitoring tool for people with focal onset epileptic seizures The device continuously records brain cardiorespiratory and physical activity data
The study aims to 1 collect benchmark data for seizure detection algorithm development and validation and 2 evaluate the performance of the device in clinical and at home workflows
Participants will wear the device during a routine Epilepsy Monitoring Unit EMU admission Additionally they can continue wearing the device at home after the EMU admission
The study aims to 1 collect benchmark data for seizure detection algorithm development and validation and 2 evaluate the performance of the device in clinical and at home workflows
Participants will wear the device during a routine Epilepsy Monitoring Unit EMU admission Additionally they can continue wearing the device at home after the EMU admission
Detailed Description:
Epilepsy a neurological disorder characterized by recurrent epileptic seizures of often complex etiology affects 65 million people globally The current reference for home use is self-reported outcomes typically via a seizure diary which leads to significant under and inaccurate reporting of seizures As seizure counting is the basis for many medical decisions the ability to accurately and unobtrusively log seizures during activities of daily living would 1 improve clinical practice by reducing the need for patients to spend time in an Epilepsy Monitoring Unit EMU and more quickly identify an appropriate treatment plan and 2 provide a means to collect real-world data RWD for research and clinical purposes
EpiCareHome is a multimodal device that can continuously record EEG with unobtrusive behind-the-ear electrodes in addition to cardiorespiratory and physical motion data The device is intended to be used by a trained healthcare professional HCP as a clinical decision support tool during the management of people with epilepsy
The clinical trial aims to analytically validate the performance of the seizure detection component of the device specifically for focal onset seizures In addition it intends to clinically validate the ability of the device to support clinical workflows from the perspective of healthcare professional and patient users alike
EpiCareHome is a multimodal device that can continuously record EEG with unobtrusive behind-the-ear electrodes in addition to cardiorespiratory and physical motion data The device is intended to be used by a trained healthcare professional HCP as a clinical decision support tool during the management of people with epilepsy
The clinical trial aims to analytically validate the performance of the seizure detection component of the device specifically for focal onset seizures In addition it intends to clinically validate the ability of the device to support clinical workflows from the perspective of healthcare professional and patient users alike
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
True
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None