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SeizEAR Safety Study

NCT07088835 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2025-12-23

No results posted yet for this study

Summary

Determine the safety and feasibility of an in-ear device to measure seizures or suspected seizures compared to the standard scalp-based electroencephalogram (EEG). The study team anticipates enrolling five healthy participants through meeting announcements and a research email list serv in the Neurology Dept. Based on the appropriate positive initial test of healthy individuals, test the in-ear device on 10 participants with seizures or suspected seizures scheduled for a clinical scalp EEG test.

Conditions

Interventions

DEVICE

SeizEAR

The in-ear electrode is a two-electrode device that fits snugly into the ear canal of the user. The device electrodes consist of a Ag/AgCl layer over a substrate. In one iteration, the substrate is a silicone rubber. In another iteration, the substrate is copper. The copper iteration consists of a Ag/AgCl ink that is manually applied to the copper, whereas the other iteration is purchased in a finished state with the Ag/Agel already adhered to the silicone. The electrodes are attached to a foam earpiece during the molding process. The foam earbud is made in-house and can be designed to be more firm or less firm.

Sponsors & Collaborators

Principal Investigators

  • Ho Wing (Andy) Chan, MD · Icahn School of Medicine at Mount Sinai

Study Design

Allocation
NON_RANDOMIZED
Purpose
DEVICE_FEASIBILITY
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-05-08
Primary Completion
2026-12-31
Completion
2026-12-31
FDA Device
Yes

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07088835 on ClinicalTrials.gov