Ear-Seizure Detection (EarSD) Study (EarSD001)

Felicia Chu

Status: Enrolling

Conditions: Seizures; Epilepsy

Treatments: Diagnostic Test: Electroencephalogram; Device: Ear-SD

Study type: Interventional

Funder types: Other

Identifiers

NCT06598189

STUDY00001889

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Age ≥ 18 years.
2. 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.
3. Willing to wear the wearable device.
4. Ability to provide informed consent

Exclusion criteria

1. Subjects wearing other ear devices such as hearing aids.
2. Inability or unwillingness to provide informed consent.
3. Irritation of the skin where the device is to be placed.
4. Patients with intracranial electrodes placement.
5. Prisoners
6. Cognitive impaired individuals
7. Pregnant Women
8. Children (Age 0-17)

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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40 participants in 1 patient group

Ear-Worn Group

Experimental group

Description:

All consented patients admitted to the Epilepsy Monitoring Unit (EMU) who are on continuous EEG (cEEG) will wear the ear-worn seizure detection device (EarSD) and there will be no randomization. The Ear-SD Device will be simultaneously worn by EMU patients on continuous video 21 electrode EEG (International 10-20 system) and single channel electrocardiogram (ECG). Daily skin assessment will be conducted and electrodes will be replaced as needed. At the end of the study, a self-reported short qualitative survey will be conducted to assess the overall experience of the enrolled subjects. The EarSD device and electrodes will be removed at the end of the study with the last skin examination.

Treatment:

Device: Ear-SD

Diagnostic Test: Electroencephalogram