Ignite Creation Date:
2024-10-26 @ 3:40 PM
Last Modification Date:
2024-10-26 @ 3:40 PM
Study NCT ID:
NCT06598189
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-08-23
Brief Title:
Ear-Seizure Detection EarSD Study
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Real-time Seizure Detection Classification and Prediction Using a Low-Cost Low-Burden Ear-worn System
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
EarSD001
Brief Summary:
The proposed study is an investigator-initiated study that aims to measure the accuracy of a wearable seizure detection and prediction device Ear-Seizure Detection Device EarSD by simultaneous recording with conventional video-EEG Electroencephalogram on patients with epileptic seizures in the Epilepsy Monitoring Unit of the hospital
Detailed Description:
A wearable seizure detection and prediction device EarSD is worn by patients with epileptic seizures In this study the goal is to validate the accuracy of a newly developed portable seizure detection device by examining if the Ear-SD device can 1 provide more comfort 2 be unobtrusive to the subject during daily activities and 3 be able to provide additional insight on a patients seizure control
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None