Status:
RECRUITING
Ear-Seizure Detection (EarSD) Study
Lead Sponsor:
Felicia Chu
Collaborating Sponsors:
University of Massachusetts, Amherst
Conditions:
Seizures
Epilepsy
Eligibility:
All Genders
18+ years
Phase:
NA
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 rec...
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 detect...
Eligibility Criteria
Inclusion
- Age ≥ 18 years.
- Patients admitted to UMass Memorial Epilepsy Monitoring Unit (EMU) for long term video-EEG monitoring as part of standard care of both focal and generalized epilepsy.
- Willing to wear the wearable device.
- Ability to provide informed consent
Exclusion
- Subjects wearing other ear devices such as hearing aids.
- Inability or unwillingness to provide informed consent.
- Irritation of the skin where the device is to be placed.
- Patients with intracranial electrodes placement.
- Prisoners
- Cognitive impaired individuals
- Pregnant Women
- Children (Age 0-17)
Key Trial Info
Start Date :
April 3 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2032
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT06598189
Start Date
April 3 2025
End Date
December 1 2032
Last Update
October 28 2025
Active Locations (2)
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1
Ummmc-Memorial Campus
Worcester, Massachusetts, United States, 01655
2
Ummmc-University Campus
Worcester, Massachusetts, United States, 01655