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Clinical trial Recruiting at 1 site Interventional Ages 18 to 70

SeizEAR: in-ear device for detecting seizures

Official title: The Safety and Feasibility of SeizEAR, an In-ear Device to Monitor Brain Waves From Temporal Lobes and Detect Abnormalities

Run by Icahn School of Medicine at Mount Sinai · NCT07088835 · Data updated 2026-11-12

This project will test whether a small in-ear device can safely detect seizures in adults first without epilepsy and then in people undergoing clinical scalp EEG for suspected temporal-lobe seizures.

Quick facts

Study typeInterventional
Ages18 Years to 70 Years
SexAll
Enrollment15 (estimated)
SponsorIcahn School of Medicine at Mount Sinai
Academic / other
Locations1 site (New York, New York)
StatusRecruiting
StartedMay 8, 2025
Main results expectedDecember 31, 2026
Study endsDecember 31, 2026
Registry record updatedSeptember 14, 2026
Trial IDNCT07088835 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal participants are adults aged 18–69 who are either healthy volunteers without a history of seizures for initial safety testing or patients scheduled for clinical scalp EEG for suspected temporal-lobe seizures.

Probably not a fit

People with active ear infections, known silver allergy, skin sensitivities of the head/ears, children, or those with non–temporal-lobe seizure types are less likely to benefit from this device in its current testing phase.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

SeizEAR is developing an in-ear sensor designed to record brain electrical activity as an alternative to scalp EEG. The study will first enroll five healthy adult volunteers to test safety and basic signal quality, then enroll about ten adults who are scheduled for clinical scalp EEG for suspected temporal-lobe seizures to compare signals simultaneously. Investigators will compare the in-ear recordings to standard scalp EEG to see if the device can capture seizure-related activity and to document any device-related adverse events. The goal is to determine feasibility, comfort, and basic performance before larger clinical testing.

Why it matters

Potential benefit: If successful, the device could provide a more comfortable, lower-cost, technician-free way to detect and monitor temporal-lobe seizure activity and improve access to EEG-like monitoring.

How similar studies have gone: Prior pilot work and early reports of intra-ear monitoring have suggested intra-ear recordings can detect seizure-related activity, but the specific SeizEAR device and full clinical validity remain novel and incompletely tested.

Who can join: the full rules

Show full inclusion / exclusion criteria 
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.

Where it's running

  • Icahn School of Medicine at Mount Sinai
    New York, New York, United States     Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
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Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.