SeizEAR Safety Study
The Safety and Feasibility of SeizEAR, an In-ear Device to Monitor Brain Waves From Temporal Lobes and Detect Abnormalities
Icahn School of Medicine at Mount Sinai
15 participants
May 8, 2025
INTERVENTIONAL
Conditions
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.
Eligibility
Plain Language Summary
Simplified for easier understanding
This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.
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Interventions
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)
View Full Details on ClinicalTrials.gov
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NCT07088835