Recruiting

Ear-Seizure Detection

Sponsor:

Felicia Chu

Code:

NCT06598189

Conditions

Seizures

Epilepsy

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

Ear-SD

Electroencephalogram

Study Details

Brief summary:

The proposed study is an investigator-initiated study that aims to measure the accuracy of a wearable seizure detection and prediction device (Ear-Seizure Detection Device (EarSD)) by simultaneous recording with conventional video-EEG (Electroencephalogram) on patients with epileptic seizures in the Epilepsy Monitoring Unit of the hospital.

Conditions

Seizures

Epilepsy

Study ID

NCT06598189

Start date

Apr 3, 2025

Status verified date

Oct, 2025

Completion date

Dec, 2032

Anticipated

Primary completion date

Dec, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

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)

Study Design

Enrollment

40 participants

Anticipated

Intervention Model

Single group

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

experimental: Ear-Worn Group

All consented patients admitted to the Epilepsy Monitoring Unit (EMU) who are on continuous EEG (cEEG) will wear the ear-worn seizure detection device (EarSD) and there will be no randomization.

The Ear-SD Device will be simultaneously worn by EMU patients on continuous video 21 electrode EEG (International 10-20 system) and single channel electrocardiogram (ECG). Daily skin assessment will be conducted and electrodes will be replaced as needed. At the end of the study, a self-reported short qualitative survey will be conducted to assess the overall experience of the enrolled subjects. The EarSD device and electrodes will be removed at the end of the study with the last skin examination.

Interventions

Ear-SD

The Ear-SD is a purely EEG recording device Continuous Electroencephalogram (cEEG), Electromyogram (EMG), Electrooculogram (EOG), Photoplethysmogram (PPG), Electrodermoactivity (EDA), and Inertial Measurement Unit (IMU). The Ear-SD device rests on the ears and connects to the scalp by two sticker electrodes.

Electroencephalogram

Standard 21-channel scalp-continuous electroencephalogram (cEEG) with video recording and electrocardiogram (ECG)

Primary outcome measure

  • Seizure Recording Criteria 1 [ Time Frame: Through study completion, an average of 7 Days ]
  • Seizure Recording Criteria 2 [ Time Frame: Through study completion, an average of 7 Days ]
  • Seizure Recording Criteria 3 [ Time Frame: Through study completion, an average of 7 Days ]
  • Data Interpretation [ Time Frame: up to 2 years ]
  • Seizure Accuracy/Prediction [ Time Frame: up to 5 years ]

Central Contacts and Locations

Central contacts

Stephanie Stephens

508-856-3939Stephanie.Stephens1@umassmed.edu

Charles Hill

Charles.hill6@umassmed.edu

Locations

Ummmc-Memorial Campus

Recruiting

Worcester, Massachusetts, United States, 01655

Contacts

Stephanie Stephens, BS

(508) 856-3939stephanie.stephens1@umassmed.edu

Charles Hill, BS

(508) 856 4667charles.hill6@umassmed.edu

Principal Investigator:

Felicia Chu, MD

Ummmc-University Campus

Recruiting

Worcester, Massachusetts, United States, 01655

Contacts

Stephanie Stephens, BS

508) 856-3939stephanie.stephens1@umassmed.edu

Charles Hill, BS

(508) 856 4667charles.hill6@umassmed.edu

Principal Investigator:

Felicia Chu, MD

More Information

Sponsor

Felicia Chu

Last update posted

Oct 28, 2025

Last verified

Oct, 2025

Keywords

  • Seizure Detection
  • Central Nervous System Diseases
  • Nervous System Diseases

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Felicia Chu on 2025-10-28.