Ear-Seizure Detection (EarSD) Study
Recruiting · NCT06598189 · Interventional (participants receive a specific treatment) · Lead sponsor: Felicia Chu
View the official record on ClinicalTrials.gov →Interventions studied
Ear-SDElectroencephalogram
What this trial is about
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.
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
Yes - healthy volunteers may be accepted
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- Age ≥ 18 years.
- 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.
- Willing to wear the wearable device.
- Ability to provide informed consent
Exclusion criteria
- Subjects wearing other ear devices such as hearing aids.
- Inability or unwillingness to provide informed consent.
- Irritation of the skin where the device is to be placed.
- Patients with intracranial electrodes placement.
- Prisoners
- Cognitive impaired individuals
- Pregnant Women
- Children (Age 0-17)
Where it is running
2 locations listed across 1 US state.
- Ummmc-Memorial Campus - Worcester, Massachusetts, United States
- Ummmc-University Campus - Worcester, Massachusetts, United States