[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100537273":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":26,"centralContacts":31,"locations":37,"responsibleParty":53,"collaborators":26,"id":55,"slug":26,"hasResults":56,"nctId":57,"briefTitle":58,"officialTitle":59,"acronym":60,"eligibilityCriteria":61,"healthyVolunteers":56,"sex":62,"minAge":63,"maxAge":26,"enrollmentInfo":64,"targetDuration":26,"studyType":67,"phases":68,"briefSummary":70,"conditions":71,"keywords":73,"overallStatus":40,"whyStopped":26,"lastUpdateSubmitDate":75,"lastUpdatePostDateStruct":76,"startDateStruct":79,"completionDateStruct":81,"leadSponsor":83,"locationsCount":84},{"fullName":5,"class":6},"Empatica, Inc.","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Control","ACTIVE_COMPARATOR","The control arm will receive multi-day visualizations of their sensor derived data but not receive SeizureWise",[13],"Device: Multi-day Visualizations",{"label":15,"type":16,"description":17,"interventionNames":18},"Personalized seizure risk score","EXPERIMENTAL","The personalized seizure risk score arm will receive multi-day visualization of their sensor derived data and also SeizureWise, an investigational algorithm which enables forecasting of future seizure probabilities based on the pattern and frequency of previous generalized tonic-clonic seizure (GTCS) events, as well as changes in physiological and behavioral variables",[19,13],"Device: SeizureWise algorithm",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DEVICE","SeizureWise algorithm","An investigational algorithm which enables forecasting of future seizure probabilities based on the pattern and frequency of previous generalized tonic-clonic seizure (GTCS) events, as well as changes in physiological and behavioral variables",[15],null,{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"Multi-day Visualizations","Multi-day visualizations of sensor derived data",[9,15],[32],{"name":33,"role":34,"phone":35,"phoneExt":26,"email":36},"Empatica Support","CONTACT","855-830-3531","support@empatica.com",[38],{"facility":39,"status":40,"city":41,"state":42,"zip":43,"country":44,"cosmosGeoPoint":45,"geoPoint":50,"contacts":51},"Empatica","RECRUITING","Boston","Massachusetts","02111","United States",{"type":46,"coordinates":47},"Point",[48,49],-71.05977,42.35843,{"lat":49,"lon":48},[52],{"name":39,"role":34,"phone":35,"phoneExt":26,"email":36},{"type":54,"investigatorFullName":26,"investigatorTitle":26,"investigatorAffiliation":26,"oldNameTitle":26,"oldOrganization":26},"SPONSOR","100537273",false,"NCT06275685","Forecasting Seizures Using Intelligent Wearable Technology for Health Tracking","Forecasting Seizures Using IntelliGent Wearable Technology for Health Tracking","Foresight","Inclusion Criteria:\n\n* Subjects must be diagnosed with or be at risk of epilepsy\n* Subjects or their parents or guardians must understand and consent to be in the study;\n* Subjects or their parents or guardians must be able to read and communicate in English;\n* Subjects or their parents or guardians must be willing and able to comply with study procedures and duration;\n* Subjects must have a wrist circumference suitable for wearing the EmbracePlus device.\n\nExclusion Criteria:\n\n* Subjects, or their parents or guardians for minor study participants, who do not understand the study and the risks;\n* Subjects, or their parents or guardians for minor study participants, who are either physically or cognitively incapable of performing study activities (e.g. filling in surveys and daily e-diary);\n* Subjects who would be placed at undue medical risk associated with any procedure called for in the protocol; or\n* Subjects that are Empatica employees and actively participated in the development of this protocol or development of the Seizure Wise algorithms.","ALL","6 Years",{"count":65,"type":66},3000,"ESTIMATED","INTERVENTIONAL",[69],"NA","The goal of this interventional study is to develop a personalized seizure risk forecast tool in people with epilepsy.\n\nThe main questions it aims to answer are:\n\n* can we develop a future seizure probabilities tool that is more accurate than chance based on the pattern and frequency of previous generalized tonic-clonic seizure (GTCS) events, as well as changes in physiological and behavioral variables.\n* does this tool improve the lives of people with epilepsy?\n\nResearchers will compare a group that does not have access to the forecast tool to a group that does and see if it is accurate and if people with it report that it improved their quality of life.",[72],"Epilepsy; Seizure",[74],"forecasting","2024-09-10",{"date":77,"type":78},"2024-09-19","ACTUAL",{"date":80,"type":78},"2024-04-11",{"date":82,"type":66},"2026-06",{"name":5,"class":6},1]