NCT07088835Recruiting
SeizEAR Safety Study
The Safety and Feasibility of SeizEAR, an In-ear Device to Monitor Brain Waves From Temporal Lobes and Detect Abnormalities
Source: ClinicalTrials.gov · Last updated 14 Sept 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 15 (estimated)
- First submitted
- 17 Jul 2025
- Start date
- May 2025
- Primary completion date
- Dec 2026
- Lead sponsor
- Icahn School of Medicine at Mount Sinai
- Diseases
- Epilepsy
- NCT number
- NCT07088835
What you commit to
- Study type: Interventional
- Planned participants: 15
- From May 2025 to the primary completion date, Dec 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Concurrent participation in another investigational protocol.
- Treatment for an ear infection in the previous four-week period
- Treatment for an ear infection in the previous four-week period.
- Concurrent participation in another investigational protocol
Other illness
- History of seizures or seizure-like activity based on self-assessment
- Any major health conditions based upon self-report
- A history of skin sensitivity, or rash on the head, neck or ears.
- A history of silver allergy.
- 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
- A history of skin sensitivity, or rash on the head, neck or ears
- A history of silver allergy.
- Any psychiatric disorder (i.e. uncontrolled depression, mood disorders, cognitive impairment, schizophrenia), that complicate measurement of changes associated with the EEG testing.
Other
- Any major issues with the skull or ear that would interfere with the EEG testing.
Who the study is looking for
- 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
- 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.
Criteria the registry did not label
- Healthy Participants
Age in the registry: 18 years to 70 years · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Icahn School of Medicine at Mount Sinai Coordinator of this site? Confirm its status | New York | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.