Recruiting

In-Ear Device

Sponsor:

Icahn School of Medicine at Mount Sinai

Code:

NCT07088835

Conditions

Epilepsy

Eligibility Criteria

Sex: All

Age: 18 - 70

Healthy Volunteers: Accepted

Interventions

SeizEAR

Study Details

Brief 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

Epilepsy

Study ID

NCT07088835

Start date

May 8, 2025

Status verified date

Nov, 2025

Completion date

Dec 31, 2026

Anticipated

Primary completion date

Dec 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70

Healthy Volunteers: Accepted

Healthy Participants

Inclusion Criteria:

  • Age: > 18 and <70
  • No History of Seizures or seizure-like activity based on self-report
  • Normal parameters for vitals, afebrile, blood pressure.
  • Able to read and write English
  • Capable of providing informed consent

Exclusion Criteria:

  • History of seizures or seizure-like activity based on self-assessment
  • Any major health conditions based upon self-report
  • Concurrent participation in another investigational protocol.
  • A history of skin sensitivity, or rash on the head, neck or ears.
  • A history of silver allergy.
  • Treatment for an ear infection in the previous four-week period
  • Medications that would be contraindicated to participate in the study that would interfere with the EEG Testing

Phase 3 Inclusion/Exclusion Criteria: Participants with Seizures or Suspected Temporal Lobe Seizures

Inclusion Criteria:

  • Age > 18 and < 70
  • Individuals scheduled for clinical EEG for seizures or suspected temporal lobe seizures documented by a neurologist
  • Stable Health Conditions based upon the principal investigator's opinion
  • Normal parameters for vitals, afebrile, blood pressure
  • Able to read and write English
  • Capable of providing informed consent.

Exclusion Criteria:

  • Any major issues with the skull or ear that would interfere with the EEG testing.
  • A history of skin sensitivity, or rash on the head, neck or ears
  • A history of silver allergy.
  • Treatment for an ear infection in the previous four-week period.
  • Concurrent participation in another investigational protocol
  • Any psychiatric disorder (i.e. uncontrolled depression, mood disorders, cognitive impairment, schizophrenia), that complicate measurement of changes associated with the EEG testing.

Study Design

Enrollment

15 participants

Anticipated

Allocation

Non randomized

Intervention Model

Sequential

Primary purpose

Device Feasibility

Interventions and Outcome Measures

Arms

experimental: Healthy Participants

Participants with no seizures or suspected temporal lobe seizures.

experimental: Participants with seizures or suspected temporal lobe seizures

Participants with seizures or suspected temporal lobe seizures scheduled for a clinical EEG.

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.

Primary outcome measure

  • Sensitivity [ Time Frame: at week 16 ]
  • F1 score [ Time Frame: at week 16 ]
  • Positive predictive value (PPV) [ Time Frame: at week 16 ]
  • False detection rate [ Time Frame: at week 16 ]
  • Comfort Rating Scale [ Time Frame: at week 16 ]

Central Contacts and Locations

Central contacts

Mary Catherine George, PhD

212-241-0784mary-catherine.george@mssm.edu

Toni Kavanagh, NP

212-241-2401toni.kavanagh@mountsinai.org

Locations

Icahn School of Medicine at Mount Sinai

Recruiting

New York, New York, United States, 10029

More Information

Sponsor

Icahn School of Medicine at Mount Sinai

Last update posted

Dec 23, 2025

Last verified

Nov, 2025

Keywords

  • Epilepsy
  • Intracranial Electroencephalogram
  • Seizures
  • In Ear Device to Detect Seizures
  • Temporal Lobe
  • Brain Waves

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Icahn School of Medicine at Mount Sinai on 2025-12-23.