[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100526480":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":21,"centralContacts":25,"locations":30,"responsibleParty":43,"collaborators":46,"id":50,"slug":51,"hasResults":52,"nctId":53,"briefTitle":54,"officialTitle":54,"acronym":20,"eligibilityCriteria":55,"healthyVolunteers":52,"sex":56,"minAge":57,"maxAge":20,"enrollmentInfo":58,"targetDuration":20,"studyType":61,"phases":62,"briefSummary":64,"conditions":65,"keywords":20,"overallStatus":67,"whyStopped":20,"lastUpdateSubmitDate":68,"lastUpdatePostDateStruct":69,"startDateStruct":72,"completionDateStruct":74,"leadSponsor":76,"locationsCount":77},{"fullName":5,"class":6},"Brigham and Women's Hospital","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Study subjects","EXPERIMENTAL","The subject will lie with the Tactilus Bodyfitter on their mattress. Subjects will initially be asked to lie in the 4 cardinal body positions (prone, supine, left, and right) to calibrate the body position recognition software. Subjects will be monitored for the rest of their EMU which will be performed as usual.",[13],"Device: Study Subjects",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DEVICE","Study Subjects","The subject will be monitored as they lie on the Tactilus Bodyfitter sensor.",[9],null,[22],{"name":23,"affiliation":5,"role":24},"Jong Woo Lee, MD, PhD","PRINCIPAL_INVESTIGATOR",[26],{"name":23,"role":27,"phone":28,"phoneExt":20,"email":29},"CONTACT","617-732-7547","jlee38@bwh.harvard.edu",[31],{"facility":5,"status":20,"city":32,"state":33,"zip":34,"country":35,"countryCode":36,"cosmosGeoPoint":37,"geoPoint":42,"contacts":20},"Boston","Massachusetts","02115","United States","US",{"type":38,"coordinates":39},"Point",[40,41],-71.05977,42.35843,{"lat":41,"lon":40},{"type":24,"investigatorFullName":44,"investigatorTitle":45,"investigatorAffiliation":5,"oldNameTitle":20,"oldOrganization":20},"Jong Woo Lee","Associate Professor of Neurology",[47],{"name":48,"class":49},"Soterya Inc.","UNKNOWN","100526480","a-device-to-prevent-sudden-unexpected-death-in-epilepsy-detecting-peri-ictal-body-position-100526480",false,"NCT06135285","A Device to Prevent Sudden Unexpected Death in Epilepsy: Detecting Peri-Ictal Body Position","Inclusion criteria:\n\n1\\. Adults 18 years of age or older admitted to the BWH EMU with drug-resistant epilepsy, defined by the failure of at least two anti-seizure medications and a documented history of electroclinical seizures\n\nExclusion criteria:\n\n1. Suspicion of functional dissociative seizures (psychogenic nonepileptic seizures)\n2. Patients admitted for medication adjustment only","ALL","18 Years",{"count":59,"type":60},50,"ESTIMATED","INTERVENTIONAL",[63],"NA","The goal of this study is to assess the performance of a commercial sheet sensor in determining body position after generalized tonic-clonic (GTC) seizures. If a sheet sensor could accurately detect GTC seizures, this could be a step towards autonomously repositioning patients with the aid of a smart mattress.\n\nPrimary Objective\n\nMilestones:\n\nFeasibility objective: Monitor 50 patients with the objective of capturing at least 20 GTCS events. Primary analytic objective: Achieve detection of anatomical landmarks with body position change within 5 seconds with an accuracy of 75% both interictally and post-GTCS.\n\nSecondary Objective Detect the postictal prone position with an accuracy of 100%.",[66],"Epilepsy","NOT_YET_RECRUITING","2026-07-24",{"date":70,"type":71},"2026-07-27","ACTUAL",{"date":73,"type":60},"2026-08-15",{"date":75,"type":60},"2027-06",{"name":5,"class":6},1]