[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100436405":3},{"organization":4,"outcomesModule":7,"designInfo":18,"detailedDescription":17,"studyPopulation":21,"armGroups":17,"interventions":22,"overallOfficials":29,"centralContacts":37,"locations":46,"responsibleParty":129,"collaborators":17,"id":131,"slug":17,"hasResults":132,"nctId":133,"briefTitle":134,"officialTitle":134,"acronym":17,"eligibilityCriteria":135,"healthyVolunteers":132,"sex":136,"minAge":137,"maxAge":17,"enrollmentInfo":138,"targetDuration":141,"studyType":142,"phases":17,"briefSummary":143,"conditions":144,"keywords":146,"overallStatus":111,"whyStopped":17,"lastUpdateSubmitDate":150,"lastUpdatePostDateStruct":151,"startDateStruct":154,"completionDateStruct":156,"leadSponsor":158,"locationsCount":159},{"fullName":5,"class":6},"Ceribell Inc.","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":17,"otherOutcomes":17},[9,13],{"measure":10,"description":11,"timeFrame":12},"Perform Confusion Assessment Method for the ICU (CAM-ICU) assessment","Research coordinator will perform and collect CAM-ICU assessment data on study subjects","3 times per day, for a maximum of six (6) days",{"measure":14,"description":15,"timeFrame":16},"Perform Electroencephalogram (EEG) Test","Record and collect EEG brain waves on study subjects using Ceribell Rapid Response EEG to assess multiple time-frequency EEG features to differentiate between delirium positive and delirium negative patients.","6-8 hours per day, for a maximum of six (6) days",null,{"allocation":17,"interventionModel":17,"interventionModelDescription":17,"primaryPurpose":17,"observationalModel":19,"timePerspective":20,"maskingInfo":17},"CASE_CONTROL","PROSPECTIVE","Subjects who experience at least one delirious episode during their ICU stay",[23],{"type":24,"name":25,"description":26,"armGroupLabels":17,"otherNames":27},"DEVICE","Electroencephalogram (EEG) Test","EEG test and delirium assessments will be performed on subjects experiencing delirium in the ICU.",[28],"Delirium Assessments",[30,34],{"name":31,"affiliation":32,"role":33},"Jose Maldonado, MD","Stanford University","PRINCIPAL_INVESTIGATOR",{"name":35,"affiliation":36,"role":33},"Timothy Girard, MD","University of Pittsburgh",[38,43],{"name":39,"role":40,"phone":41,"phoneExt":17,"email":42},"Michelle Hofmann, MSN","CONTACT","800-436-0826","michelle.hofmann@ceribell.com",{"name":44,"role":40,"phone":41,"phoneExt":17,"email":45},"Jessy Dorn, PhD","jessy.dorn@ceribell.com",[47,60,70,80,90,100,110],{"facility":32,"status":48,"city":49,"state":50,"zip":51,"country":52,"countryCode":53,"cosmosGeoPoint":54,"geoPoint":59,"contacts":17},"ACTIVE_NOT_RECRUITING","Stanford","California","94305","United States","US",{"type":55,"coordinates":56},"Point",[57,58],-122.16608,37.42411,{"lat":58,"lon":57},{"facility":61,"status":48,"city":62,"state":63,"zip":64,"country":52,"countryCode":53,"cosmosGeoPoint":65,"geoPoint":69,"contacts":17},"Naples Community Hospital","Naples","Florida","34102",{"type":55,"coordinates":66},[67,68],-81.79596,26.14234,{"lat":68,"lon":67},{"facility":71,"status":48,"city":72,"state":73,"zip":74,"country":52,"countryCode":53,"cosmosGeoPoint":75,"geoPoint":79,"contacts":17},"University of Iowa Hospitals & Clinics","Iowa City","Iowa","52242",{"type":55,"coordinates":76},[77,78],-91.53017,41.66113,{"lat":78,"lon":77},{"facility":81,"status":48,"city":82,"state":83,"zip":84,"country":52,"countryCode":53,"cosmosGeoPoint":85,"geoPoint":89,"contacts":17},"Mercy","St Louis","Missouri","63141",{"type":55,"coordinates":86},[87,88],-90.19789,38.62727,{"lat":88,"lon":87},{"facility":91,"status":48,"city":92,"state":93,"zip":94,"country":52,"countryCode":53,"cosmosGeoPoint":95,"geoPoint":99,"contacts":17},"Cooper Health","Camden","New Jersey","08103",{"type":55,"coordinates":96},[97,98],-75.11962,39.92595,{"lat":98,"lon":97},{"facility":101,"status":48,"city":102,"state":103,"zip":104,"country":52,"countryCode":53,"cosmosGeoPoint":105,"geoPoint":109,"contacts":17},"UNC Health Rex","Raleigh","North Carolina","27607",{"type":55,"coordinates":106},[107,108],-78.63861,35.7721,{"lat":108,"lon":107},{"facility":36,"status":111,"city":112,"state":113,"zip":114,"country":52,"countryCode":53,"cosmosGeoPoint":115,"geoPoint":119,"contacts":120},"RECRUITING","Pittsburgh","Pennsylvania","15213",{"type":55,"coordinates":116},[117,118],-79.99589,40.44062,{"lat":118,"lon":117},[121,125,128],{"name":122,"role":40,"phone":123,"phoneExt":17,"email":124},"Nicole Ann Toney","412-648-0608","nat88@pitt.edu",{"name":126,"role":40,"phone":123,"phoneExt":17,"email":127},"Erik Yablonsky","ejy3@pitt.edu",{"name":35,"role":33,"phone":17,"phoneExt":17,"email":17},{"type":130,"investigatorFullName":17,"investigatorTitle":17,"investigatorAffiliation":17,"oldNameTitle":17,"oldOrganization":17},"SPONSOR","100436405",false,"NCT04962815","Ceribell Delirium Data Collection Study","Inclusion Criteria: All must be present\n\n* Age is 18 years or older\n* Admitted to the Intensive Care Unit (ICU)\n* Subject must be fluent in the language in which the delirium assessment is performed\n\nExclusion Criteria: All must be absent\n\n\\- Any condition that prevents use of the Ceribell EEG system on the subject for the entire anticipated EEG monitoring period. Examples may include: Craniectomy with missing bone flap in an area where Ceribell EEG electrodes are placed. Expected use of continuous clinical EEG for the entire anticipated monitoring period.","ALL","18 Years",{"count":139,"type":140},200,"ESTIMATED","6 Days","OBSERVATIONAL","This study is designed as a prospective, non-randomized, observational clinical study. The study will collect clinical and rrEEG (Ceribell EEG) data when monitoring subjects for delirium subtypes. EEG and clinical data will be collected for the development of future software algorithms to assess the presence and severity of delirium.",[145],"Delirium",[147,148,149],"delirium","EEG","Electroencephalogram","2025-07-22",{"date":152,"type":153},"2025-07-25","ACTUAL",{"date":155,"type":153},"2021-11-10",{"date":157,"type":140},"2026-04-01",{"name":5,"class":6},7]