EpilepsyNCT07088835
SeizEAR Safety Study
A study testing SeizEAR in people with Epilepsy, run by Icahn School of Medicine at Mount Sinai at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Epilepsy
- What is being tested?
- SeizEAR
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- 8 May 2025to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Show all 11Show fewer
- 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.
Who cannot join
- 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
Show all 14Show fewer
- 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
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Icahn School of Medicine at Mount Sinai
New York, New York, 10029
About this study
Official title: The Safety and Feasibility of SeizEAR, an In-ear Device to Monitor Brain Waves From Temporal Lobes and Detect Abnormalities
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.
Read the detailed description
SeizEAR aims to develop an in-ear device for the detection, diagnosis, and management of seizures/epilepsy. In the United States, an estimated 1 in 26 people will develop epilepsy within a lifetime, with 60% of all seizures originating in the temporal region of the brain. Electroencephalogram (EEG) is currently the gold standard for seizure detection, measuring electrical activity of the brain via numerous electrodes placed on the scalp. The demand for EEG has been steadily increasing given its higher accessibility and ability to result in substantial changes to patient management. In particular, pre-surgical evaluation of seizure was studied in the ambulatory setting, with good post-resection outcomes in selected patients with unilateral temporal lobe epilepsy. The EEG technology requires substantial technician training, can lead to patient discomfort, and still incurs high patient costs (roughly 500-3,000$ per order). Furthermore, current EEG interpretation can be complicated by high rates of false detection and poor sensitivity, as signals may be impeded by scalp conditions, the use of hair products, and other concomitant medical devices. SeizEAR will offer a technician-free, easy to use, comfortable, and cost-effective alternative to seizure monitoring. Intra-ear monitoring has been shown to permit real-time detection of seizure activity and allow for prolonged monitoring of abnormal (inter-ictal) discharges. Intra-ear monitoring is particularly suitable for temporal lobe epilepsy, given the proximity of the ear canal to the temporal lobe of the brain. Prior studies have demonstrated that intra-ear monitoring of temporal brain activity can reliably detect temporal lobe seizures with the added benefit of limiting ocular artifact, a common confounder of more traditional scalp EEG. Collaborating with the industry partner, Starkey Hearing Technologies, the researchers aim to prototype SeizEAR with two electrodes targeting the temporal lobe, wired to a signal processor/box. The objective will be to demonstrate the safety and efficacy of a first-generation SeizEAR device to monitor brain waves in healthy controls and participants with seizures or suspected temporal lobe seizures scheduled for a clinical EEG. Long term, the goal will be to validate the clinical efficacy of SeizEAR in detecting seizures
- Conditions
- Epilepsy
- Being tested
- SeizEAR
- Keywords
- Epilepsy, Intracranial Electroencephalogram, Seizures, In Ear Device to Detect Seizures, Temporal Lobe, Brain Waves
- Medical subject headings
- Epilepsy, Seizures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SeizEARDevice
Also called in-ear seizure detection 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.
| Study group | Role | What they receive |
|---|---|---|
| Healthy Participants | Experimental | Participants with no seizures or suspected temporal lobe seizures. Receives: Device: SeizEAR |
| Participants with seizures or suspected temporal lobe seizures | Experimental | Participants with seizures or suspected temporal lobe seizures scheduled for a clinical EEG. Receives: Device: SeizEAR |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: at week 16
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2025
- Study start8 May 2025
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EpilepsyStudies of the same condition, open and under way.
- More trials run by Icahn School of Medicine at Mount SinaiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Device feasibility
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Model description
- 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).
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Icahn School of Medicine at Mount Sinai
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ho Wing Chan, Icahn School of Medicine at Mount Sinai
- Investigators
- Ho Wing (Andy) Chan, MD, Principal investigator, Icahn School of Medicine at Mount Sinai
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07088835
- Sponsor's protocol ID
- STUDY-24-00433
- Other IDs
- GCO 21-1216
- Status last verified
- Sep 2026
- First submitted
- 17 Jul 2025
- Last updated
- 14 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: The study is a safety study that has potential IP for Mount Sinai only aggregate data will be published and shared.
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Safety and Feasibility of SeizEAR, an In-ear Device to Monitor Brain Waves From Temporal Lobes and Detect Abnormalities
- ClinicalTrials.gov ID
- NCT07088835
- Acronym / sponsor ID
- STUDY-24-00433
- Conditions
- Epilepsy
- Keywords
- Epilepsy, Intracranial Electroencephalogram, Seizures, In Ear Device to Detect Seizures, Temporal Lobe, Brain Waves
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Icahn School of Medicine at Mount SinaiUniversity, hospital or other
- Study start
- 8 May 2025 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 28 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
SeizEAR aims to develop an in-ear device for the detection, diagnosis, and management of seizures/epilepsy. In the United States, an estimated 1 in 26 people will develop epilepsy within a lifetime, with 60% of all seizures originating in the temporal region of the brain. Electroencephalogram (EEG) is currently the gold standard for seizure detection, measuring electrical activity of the brain via numerous electrodes placed on the scalp. The demand for EEG has been steadily increasing given its higher accessibility and ability to result in substantial changes to patient management. In particular, pre-surgical evaluation of seizure was studied in the ambulatory setting, with good post-resection outcomes in selected patients with unilateral temporal lobe epilepsy. The EEG technology requires substantial technician training, can lead to patient discomfort, and still incurs high patient costs (roughly 500-3,000$ per order). Furthermore, current EEG interpretation can be complicated by high rates of false detection and poor sensitivity, as signals may be impeded by scalp conditions, the use of hair products, and other concomitant medical devices. SeizEAR will offer a technician-free, easy to use, comfortable, and cost-effective alternative to seizure monitoring. Intra-ear monitoring has been shown to permit real-time detection of seizure activity and allow for prolonged monitoring of abnormal (inter-ictal) discharges. Intra-ear monitoring is particularly suitable for temporal lobe epilepsy, given the proximity of the ear canal to the temporal lobe of the brain. Prior studies have demonstrated that intra-ear monitoring of temporal brain activity can reliably detect temporal lobe seizures with the added benefit of limiting ocular artifact, a common confounder of more traditional scalp EEG. Collaborating with the industry partner, Starkey Hearing Technologies, the researchers aim to prototype SeizEAR with two electrodes targeting the temporal lobe, wired to a signal processor/box. The objective will be to demonstrate the safety and efficacy of a first-generation SeizEAR device to monitor brain waves in healthy controls and participants with seizures or suspected temporal lobe seizures scheduled for a clinical EEG. Long term, the goal will be to validate the clinical efficacy of SeizEAR in detecting seizures
Study design
- Primary purpose
- Device feasibility
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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).
| Arm | Type | Receives |
|---|---|---|
| Healthy Participants | Experimental | Device: SeizEARParticipants with no seizures or suspected temporal lobe seizures. |
| Participants with seizures or suspected temporal lobe seizures | Experimental | Device: SeizEARParticipants with seizures or suspected temporal lobe seizures scheduled for a clinical EEG. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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
Key exclusion criteria (14 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SeizEARAlso: in-ear seizure detection deviceThe 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. | Device | Healthy Participants, Participants with seizures or suspected temporal lobe seizures |
Primary outcome
Sensitivity
Time frame: at week 16
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).
F1 score
Time frame: at week 16
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.
Positive predictive value (PPV)
Time frame: at week 16
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.
False detection rate
Time frame: at week 16
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.
Comfort Rating Scale
Time frame: at week 16
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2026.
- Individual participant dataSharing planned: No. The study is a safety study that has potential IP for Mount Sinai only aggregate data will be published and shared.
Related trials for Epilepsy
RecruitingObservational study
Tumor Related Epilepsy
Epilepsy, Cancer
Enrolling by invitation
An Examination of Cognitive and Sensorimotor Processes in Patients With Epilepsy
Epilepsy
RecruitingObservational study
Investigating Epilepsy: Screening and Evaluation
Seizures, Epilepsy
RecruitingPhase 3
Study Evaluating the Efficacy and Safety of RAP-219 in Adult Participants With Focal Seizures FOCUS-1
Focal Seizure, Epilepsy
Enrolling by invitationObservational study
Neurophysiological Intraoperative or Epilepsy Monitoring
Patients Operated on at the Neurosurgery Department
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ho Wing (Andy) Chan, MD principal investigator
Icahn School of Medicine at Mount Sinai
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SeizEAR in people with Epilepsy, run by Icahn School of Medicine at Mount Sinai at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 14 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mary Catherine George, PhD (212-241-0784, mary-catherine.george@mssm.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sensitivity (time frame: at week 16). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Sep 2026.