[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100562055":3},{"organization":4,"armGroups":7,"interventions":15,"overallOfficials":27,"centralContacts":32,"locations":41,"responsibleParty":76,"collaborators":80,"id":83,"slug":84,"hasResults":85,"nctId":86,"briefTitle":87,"officialTitle":88,"acronym":89,"eligibilityCriteria":90,"healthyVolunteers":91,"sex":92,"minAge":93,"maxAge":21,"enrollmentInfo":94,"targetDuration":21,"studyType":97,"phases":98,"briefSummary":100,"conditions":101,"keywords":104,"overallStatus":44,"whyStopped":21,"lastUpdateSubmitDate":108,"lastUpdatePostDateStruct":109,"startDateStruct":112,"completionDateStruct":114,"leadSponsor":116,"locationsCount":117},{"fullName":5,"class":6},"University of Massachusetts, Worcester","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Ear-Worn Group","EXPERIMENTAL","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.\n\nThe 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.",[13,14],"Device: Ear-SD","Diagnostic Test: Electroencephalogram",[16,22],{"type":17,"name":18,"description":19,"armGroupLabels":20,"otherNames":21},"DEVICE","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.",[9],null,{"type":23,"name":24,"description":25,"armGroupLabels":26,"otherNames":21},"DIAGNOSTIC_TEST","Electroencephalogram","Standard 21-channel scalp-continuous electroencephalogram (cEEG) with video recording and electrocardiogram (ECG)",[9],[28],{"name":29,"affiliation":30,"role":31},"Felicia Chu, MD","UMass Neurology Department","PRINCIPAL_INVESTIGATOR",[33,38],{"name":34,"role":35,"phone":36,"phoneExt":21,"email":37},"Stephanie Stephens","CONTACT","508-856-3939","Stephanie.Stephens1@umassmed.edu",{"name":39,"role":35,"phone":21,"phoneExt":21,"email":40},"Charles Hill","Charles.hill6@umassmed.edu",[42,66],{"facility":43,"status":44,"city":45,"state":46,"zip":47,"country":48,"countryCode":49,"cosmosGeoPoint":50,"geoPoint":55,"contacts":56},"Ummmc-Memorial Campus","RECRUITING","Worcester","Massachusetts","01655","United States","US",{"type":51,"coordinates":52},"Point",[53,54],-71.80229,42.26259,{"lat":54,"lon":53},[57,61,65],{"name":58,"role":35,"phone":59,"phoneExt":21,"email":60},"Stephanie Stephens, BS","(508) 856-3939","stephanie.stephens1@umassmed.edu",{"name":62,"role":35,"phone":63,"phoneExt":21,"email":64},"Charles Hill, BS","(508) 856 4667","charles.hill6@umassmed.edu",{"name":29,"role":31,"phone":21,"phoneExt":21,"email":21},{"facility":67,"status":44,"city":45,"state":46,"zip":47,"country":48,"countryCode":49,"cosmosGeoPoint":68,"geoPoint":70,"contacts":71},"Ummmc-University Campus",{"type":51,"coordinates":69},[53,54],{"lat":54,"lon":53},[72,74,75],{"name":58,"role":35,"phone":73,"phoneExt":21,"email":60},"508) 856-3939",{"name":62,"role":35,"phone":63,"phoneExt":21,"email":64},{"name":29,"role":31,"phone":21,"phoneExt":21,"email":21},{"type":77,"investigatorFullName":78,"investigatorTitle":79,"investigatorAffiliation":5,"oldNameTitle":21,"oldOrganization":21},"SPONSOR_INVESTIGATOR","Felicia Chu","Assistant Professor",[81],{"name":82,"class":6},"University of Massachusetts, Amherst","100562055","ear-seizure-detection-earsd-study-100562055",false,"NCT06598189","Ear-Seizure Detection (EarSD) Study","Real-time Seizure Detection, Classification, and Prediction Using a Low-Cost Low-Burden Ear-worn System","EarSD001","Inclusion Criteria:\n\n1. Age ≥ 18 years.\n2. 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.\n3. Willing to wear the wearable device.\n4. Ability to provide informed consent\n\nExclusion Criteria:\n\n1. Subjects wearing other ear devices such as hearing aids.\n2. Inability or unwillingness to provide informed consent.\n3. Irritation of the skin where the device is to be placed.\n4. Patients with intracranial electrodes placement.\n5. Prisoners\n6. Cognitive impaired individuals\n7. Pregnant Women\n8. Children (Age 0-17)",true,"ALL","18 Years",{"count":95,"type":96},40,"ESTIMATED","INTERVENTIONAL",[99],"NA","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.",[102,103],"Seizures","Epilepsy",[105,106,107],"Seizure Detection","Central Nervous System Diseases","Nervous System Diseases","2025-10-24",{"date":110,"type":111},"2025-10-28","ACTUAL",{"date":113,"type":111},"2025-04-03",{"date":115,"type":96},"2032-12",{"name":78,"class":6},2]