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Ear-Worn gadget aims to predict seizures before they start

NCT ID NCT06598189

Diagnosis Sponsor: Felicia Chu 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026

Summary

This study is testing a wearable device that sits on the ears and uses sensors to detect and predict seizures in people with epilepsy. The device records brain, muscle, and eye activity, along with heart rate and skin signals. It will be compared to standard hospital EEG monitoring in 40 adults admitted to the epilepsy monitoring unit. The goal is to see if the device can accurately spot seizures and even predict them a minute ahead.

What this could mean

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

Active substance
Ear-SD device (ear-worn EEG, EMG, EOG, PPG, EDA, IMU sensors)
What this could lead to
If successful, this could provide a low-cost, comfortable way to detect and predict seizures in real time, improving epilepsy management.
What could go wrong
This is a small, early-stage study (40 participants) testing accuracy in a hospital setting. The device may not work as well in daily life, and false alarms or missed seizures are possible.

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 40 people

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

Started

Apr 2025

Expected to finish

Dec 2032

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 years and older

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.

Inclusion Criteria: 1. Age ≥ 18 years. 2. Patients admitted to UMass Memorial Epilepsy Monitoring Unit (EMU) for long term video-EEG monitoring as part of standard care of both focal and generalized epilepsy. 3. Willing to wear the wearable device. 4. Ability to provide informed consent Exclusion Criteria: 1. Subjects wearing other ear devices such as hearing aids. 2. Inability or unwillingness to provide informed consent. 3. Irritation of the skin where the device is to be placed. 4. Patients with intracranial electrodes placement. 5. Prisoners 6. Cognitive impaired individuals 7. Pregnant Women 8. Children (Age 0-17)

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Conditions

The condition(s) this trial relates to.

central nervous system disorder epilepsy nervous system disorder visual epilepsy

As listed by the trial registrant

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

Epilepsy Seizures

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    2 sites. 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

  • Ummmc-Memorial Campus

    RECRUITING

    Worcester, Massachusetts, 01655, United States

  • Ummmc-University Campus

    RECRUITING

    Worcester, Massachusetts, 01655, United States

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