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SeizEAR Safety Study
Sponsor: Icahn School of Medicine at Mount Sinai
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.
Official title: The Safety and Feasibility of SeizEAR, an In-ear Device to Monitor Brain Waves From Temporal Lobes and Detect Abnormalities
Key Details
Gender
All
Age Range
18 Years - 70 Years
Study Type
INTERVENTIONAL
Enrollment
15
Start Date
2025-05-08
Completion Date
2026-12-31
Last Updated
2025-12-23
Healthy Volunteers
Yes
Conditions
Interventions
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.
Locations (1)
Icahn School of Medicine at Mount Sinai
New York, New York, United States