NCT06598189

Ear-Seizure Detection (EarSD) Study

Real-time Seizure Detection, Classification, and Prediction Using a Low-Cost Low-Burden Ear-worn System

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Felicia Chu · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• Seizures
• Epilepsy

Interventions

Type	Name	Description
DEVICE	Ear-SD	The Ear-SD is a purely EEG recording device Continuous Electroencephalogram (cEEG), Electromyogram (EMG), Electrooculogram (EOG), Photoplethysmogram (PPG), Electrodermoactivity (EDA), and Inertial Measurement Unit (IMU). The Ear-SD device rests on the ears and connects to the scalp by two sticker electrodes.
DIAGNOSTIC_TEST	Electroencephalogram	Standard 21-channel scalp-continuous electroencephalogram (cEEG) with video recording and electrocardiogram (ECG)

Timeline

• Start date: 2025-04-03
• Primary completion: 2027-12-01
• Completion: 2032-12-01
• First posted: 2024-09-19
• Last updated: 2025-10-28

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated device study