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Ear device could spot seizures without wires

NCT ID NCT07088835

Diagnosis Sponsor: Icahn School of Medicine at Mount Sinai Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Sep 15, 2026 · Updated 2 times

Summary

This study is testing a small device that fits in the ear to detect seizures by measuring brain waves. Researchers will first test it on 5 healthy people, then on 10 people with epilepsy who are already scheduled for a standard scalp EEG. The goal is to see if the in-ear device is safe, comfortable, and accurate compared to the usual method.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
SeizEAR in-ear seizure detection device
What this could lead to
If successful, this could lead to a more convenient and less noticeable way to monitor seizures, potentially improving epilepsy management.
What could go wrong
This is a very early, small feasibility study with only 15 participants. The device may not be as accurate as standard EEG, and comfort or fit issues could arise.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 15 people

The number the study aims to enrol. It can still change while the study runs.

Started

May 2025

Expected to finish

Dec 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 70 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

epilepsy temporal lobe epilepsy visual epilepsy

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Epilepsy

How to take part

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  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Icahn School of Medicine at Mount Sinai

    RECRUITING

    New York, New York, 10029, United States

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