SeizEAR Safety Study

NCT07088835 | Recruiting FDA Device

• 2 other identifiers: STUDY-24-00433GCO 21-1216
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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

Keywords

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

Outcome Measures

Primary Outcomes (5)

• Sensitivity

  The sensitivity of ear-EEG will be measured by sensitivity the percentage of ear-EEG predictions that overlap with conventional EEG annotations for at least 1 second per 24 hours accordingly. The ear-EEG annotations will be considered as predictions and the conventional EEG annotations as the truth. Any prediction was deemed true if they overlap at least 1 second with the truth. All seizure annotations were either true positive (TP), false positive (FP), or false negative (FN).

  at week 16

• F1 score

  The Device F1 Score is a metric used to evaluate the performance of the ear-EEG device in detecting seizures. It is the harmonic mean of precision and recall, providing a balance between these two metrics. Precision is the proportion of true positive (TP) predictions out of all positive predictions (TP + FP), while recall (or sensitivity) is the proportion of true positive (TP) predictions out of all actual seizure events. The F1 Score ranges from 0 to 1, with higher scores indicating better performance in accurately detecting seizures. The performance of ear-EEG will be measured by the device F1 score per 24 hours accordingly.

  at week 16

• Positive predictive value (PPV)

  The Device Positive Predictive Value (PPV) is calculated by dividing the number of true positives (TP) by the total number of positive test results (TP + FP), where FP represents false positives. PPV measures the accuracy of the ear-EEG device in predicting seizures, indicating the likelihood that a positive prediction made by the device is a true seizure event. The PPV ranges from 0 to 1, with higher values indicating better accuracy in predicting seizures. The performance of ear-EEG will be measured by the positive predictive value (PPV) per 24 hours accordingly.

  at week 16

• False detection rate

  The Device False Detection Rate is a metric used to evaluate the performance of the ear-EEG device in terms of false positives. It is calculated by dividing the number of false positives (FP) by the total number of test results (TP + FP + FN), where TP represents true positives and FN represents false negatives. The false detection rate is typically expressed as the number of false positive predictions per 24 hours. Lower values indicate better performance, with fewer false alarms generated by the device.. The performance of ear-EEG will be measured by false detection rate per 24 hours accordingly.

  at week 16

• Comfort Rating Scale

  The Comfort Rating Scale is a 6-item questionnaire that asks participants about their comfort with the device. Responses are on a 5-point Likert scale ranging from 0 (not comfortable at all) to 5 (completely comfortable). The items assessed include tightness, weight, security, softness, overall comfort, and overall fit of the device in the ear. Total scores range from 0 to 30, with higher scores indicating greater comfort.

  at week 16

Study Arms (2)

Healthy Participants

EXPERIMENTAL

Participants with no seizures or suspected temporal lobe seizures.

Device: SeizEAR

Participants with seizures or suspected temporal lobe seizures

EXPERIMENTAL

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

Device: SeizEAR

Interventions

SeizEAR DEVICE

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.

Also known as: in-ear seizure detection device

Healthy Participants; Participants with seizures or suspected temporal lobe seizures

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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.
• 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

Sponsors & Collaborators

• Icahn School of Medicine at Mount Sinai: lead

Study Sites (1)

Icahn School of Medicine at Mount Sinai

New York, New York, 10029, United States

RECRUITING

MeSH Terms

Conditions

Epilepsy; Seizures

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Ho Wing (Andy) Chan, MD

  Icahn School of Medicine at Mount Sinai

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mary Catherine George, PhD

CONTACT

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

Toni Kavanagh, NP

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Instructor of Neurology and Psychiatry

Model Details: The study will enroll the healthy participants first to determine any issues with the device pertaining to safety or issues in comparison to the Gold Standard of EEG for testing for seizures. Once the healthy participants cohort completed (5), the study will begin enrolling participants with seizures or suspected seizures who are scheduled for a clinical EEG (10).

Study Record Dates

• First Submitted: July 17, 2025
• First Posted: July 28, 2025
• Study Start: May 8, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: December 23, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)