[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100635566":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":20,"centralContacts":25,"locations":31,"responsibleParty":59,"collaborators":10,"id":61,"slug":10,"hasResults":62,"nctId":63,"briefTitle":64,"officialTitle":65,"acronym":10,"eligibilityCriteria":66,"healthyVolunteers":62,"sex":67,"minAge":68,"maxAge":10,"enrollmentInfo":69,"targetDuration":10,"studyType":72,"phases":10,"briefSummary":73,"conditions":74,"keywords":10,"overallStatus":76,"whyStopped":10,"lastUpdateSubmitDate":77,"lastUpdatePostDateStruct":78,"startDateStruct":81,"completionDateStruct":83,"leadSponsor":85,"locationsCount":86},{"fullName":5,"class":6},"RespirAI US Inc","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"High risk COPD patients",null,"Adults aged 21 years and older with physician-diagnosed COPD who are at high risk for exacerbations, wearing a study device for 6 months.",[13],"Device: RespirAI",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":10},"DEVICE","RespirAI","Use of a software-based monitoring device for 6 months.",[9],[21],{"name":22,"affiliation":23,"role":24},"Adam D Wells, MD, FCCP","Nebraska Methodist Hospital","PRINCIPAL_INVESTIGATOR",[26],{"name":27,"role":28,"phone":29,"phoneExt":10,"email":30},"Tamar Sobol","CONTACT","(617) 615-6799‬","info@respriai.com",[32],{"facility":33,"status":10,"city":34,"state":35,"zip":36,"country":37,"cosmosGeoPoint":38,"geoPoint":43,"contacts":44},"Methodist Physicians Clinic","Omaha","Nebraska","68114","United States",{"type":39,"coordinates":40},"Point",[41,42],-95.94043,41.25626,{"lat":42,"lon":41},[45,49,53,54,57],{"name":46,"role":28,"phone":47,"phoneExt":10,"email":48},"DruAnne H McMartin, CCRC, MA","402-354-0350","dru.mcmartin@nmhs.org",{"name":50,"role":28,"phone":51,"phoneExt":10,"email":52},"Rebecca A Van Winkle, RN, BSN","(402) 354-0350","rebecca.vanwinkle@nmhs.org",{"name":22,"role":24,"phone":10,"phoneExt":10,"email":10},{"name":55,"role":56,"phone":10,"phoneExt":10,"email":10},"Michael J Sanley, MD","SUB_INVESTIGATOR",{"name":58,"role":56,"phone":10,"phoneExt":10,"email":10},"Zachariah L Wittenberg, DO",{"type":60,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR","100635566",false,"NCT07554352","Early Detection of COPD Exacerbations Using Home Monitoring Device","A Multi-center, Observational Prospective Clinical Study to Evaluate the Safety and Effectiveness of a Home - Monitoring COPD Management Software for Early Detection of Exacerbations.","Inclusion Criteria:\n\n* Age \\>21 years.\n* Physician-diagnosed COPD at least 6 months prior to screening visit.\n* Two or more moderate COPD exacerbations in the past 6 months or 1 severe exacerbation during the past 6 months.\n* Free of exacerbation for 1 month before enrollment.\n\nExclusion Criteria:\n\n* Unable or willing to sign an informed consent.\n* Unable to complete the 6-minute walk test due to physical or mental health conditions.\n* Patients with cardiac pacemaker, defibrillators, or other implanted electronic devices.\n* Pregnancy\n* Study clinician determines that the patient is unable or unwilling to comply with all study procedures.","ALL","21 Years",{"count":70,"type":71},30,"ESTIMATED","OBSERVATIONAL","The goal of this observational study is to evaluate the safety and effectiveness of a home-monitoring device (RespirAI) in the early detection of COPD exacerbations in adults (age \\>21) with physician-diagnosed COPD who are at high risk for exacerbations. The study will collect data from participants with COPD that will be analyzed using an AI-based algorithm to predict exacerbation events. The device's predictions will then be compared against clinically documented exacerbations to assess detection accuracy.",[75],"COPD Exacerbation","NOT_YET_RECRUITING","2026-04-21",{"date":79,"type":80},"2026-04-28","ACTUAL",{"date":82,"type":71},"2026-05",{"date":84,"type":71},"2027-05",{"name":5,"class":6},1]