[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100653896":3},{"organization":4,"outcomesModule":7,"designInfo":30,"detailedDescription":29,"studyPopulation":29,"armGroups":36,"interventions":43,"overallOfficials":49,"centralContacts":53,"locations":59,"responsibleParty":76,"collaborators":79,"id":85,"slug":86,"hasResults":87,"nctId":88,"briefTitle":89,"officialTitle":89,"acronym":29,"eligibilityCriteria":90,"healthyVolunteers":87,"sex":91,"minAge":92,"maxAge":93,"enrollmentInfo":94,"targetDuration":29,"studyType":97,"phases":98,"briefSummary":99,"conditions":100,"keywords":104,"overallStatus":107,"whyStopped":29,"lastUpdateSubmitDate":108,"lastUpdatePostDateStruct":109,"startDateStruct":112,"completionDateStruct":114,"leadSponsor":116,"locationsCount":117},{"fullName":5,"class":6},"Children's Hospital Los Angeles","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":16,"otherOutcomes":29},[9,13],{"measure":10,"description":11,"timeFrame":12},"Agreement Between Prototype Wearable Stethoscope and Thinklabs One Digital Stethoscope","Agreement between the prototype wearable stethoscope and the FDA-cleared Thinklabs One Digital Stethoscope in the classification of normal versus abnormal lung sounds, assessed using Cohen's Kappa.","Single study visit (up to 90 minutes).",{"measure":14,"description":15,"timeFrame":12},"Association Between Lung Sounds and Asthma Control Scores","Association between abnormal lung sounds detected by the prototype wearable stethoscope and asthma control as measured by the Childhood Asthma Control Test (cACT) or Asthma Control Test (ACT).",[17,20,23,26],{"measure":18,"description":19,"timeFrame":12},"Sensitivity of Abnormal Lung Sound Detection","Sensitivity of the prototype wearable stethoscope for detecting abnormal lung sounds compared with Thinklabs One Digital Stethoscope recordings",{"measure":21,"description":22,"timeFrame":12},"Specificity of Abnormal Lung Sound Detection","Specificity of the prototype wearable stethoscope for detecting abnormal lung sounds compared with Thinklabs One Digital Stethoscope recordings",{"measure":24,"description":25,"timeFrame":12},"Positive Predictive Value (PPV)","Positive predictive value of the prototype wearable stethoscope for identifying abnormal lung sounds compared with Thinklabs One Digital Stethoscope recordings.",{"measure":27,"description":28,"timeFrame":12},"Negative Predictive Value (NPV)","Negative predictive value of the prototype wearable stethoscope for identifying abnormal lung sounds compared with Thinklabs One Digital Stethoscope recordings.",null,{"allocation":31,"interventionModel":32,"interventionModelDescription":29,"primaryPurpose":33,"observationalModel":29,"timePerspective":29,"maskingInfo":34},"NA","SINGLE_GROUP","DIAGNOSTIC",{"masking":35,"maskingDescription":29,"whoMasked":29},"NONE",[37],{"label":38,"type":39,"description":40,"interventionNames":41},"Prototype Wearable Stethoscope Evaluation","EXPERIMENTAL","Participants aged 4 to 17 years with asthma will complete asthma control questionnaires, undergo pre- and post-bronchodilator spirometry, and have lung sounds recorded simultaneously using a prototype wearable stethoscope and four Thinklabs One Digital Stethoscopes. Lung sound recordings obtained before and after bronchodilator administration will be used to evaluate agreement between devices and assess associations between detected lung sounds, lung function, and asthma control",[42],"Device: Prototype Wearable Stethoscope",[44],{"type":45,"name":46,"description":47,"armGroupLabels":48,"otherNames":29},"DEVICE","Prototype Wearable Stethoscope","The Prototype Wearable Stethoscope is a wireless device used to record lung sounds in children with asthma. Recordings will be compared with a standard digital stethoscope to evaluate device performance.",[38],[50],{"name":51,"affiliation":5,"role":52},"Roberta Kato, MD","PRINCIPAL_INVESTIGATOR",[54],{"name":55,"role":56,"phone":57,"phoneExt":29,"email":58},"Danny Del Cid-Linares","CONTACT","310-445-0919","ddelcidlinares@chla.usc.edu",[60],{"facility":5,"status":29,"city":61,"state":62,"zip":63,"country":64,"countryCode":65,"cosmosGeoPoint":66,"geoPoint":71,"contacts":72},"Los Angeles","California","90027","United States","US",{"type":67,"coordinates":68},"Point",[69,70],-118.24368,34.05223,{"lat":70,"lon":69},[73,75],{"name":55,"role":56,"phone":74,"phoneExt":29,"email":58},"3233611983",{"name":51,"role":52,"phone":29,"phoneExt":29,"email":29},{"type":52,"investigatorFullName":77,"investigatorTitle":78,"investigatorAffiliation":5,"oldNameTitle":29,"oldOrganization":29},"Roberta Kato","Medical Staff\u002FUSC Faculty CWR",[80,83],{"name":81,"class":82},"National Heart, Lung, and Blood Institute (NHLBI)","NIH",{"name":84,"class":6},"University of Southern California","100653896","asthma-lung-sounds-with-wearable-stethoscope-100653896",false,"NCT07792330","Asthma Lung Sounds With Wearable Stethoscope","Inclusion Criteria:\n\n* Children and adolescents aged 4 to 17 years\n* Diagnosis of asthma\n* Ability to perform spirometry\n* Assent (as applicable) and parental\u002Flegal guardian permission obtained\n\nExclusion Criteria:\n\n* Unable to follow spirometry procedures\n* Intubated at the time of enrollment","ALL","4 Years","17 Years",{"count":95,"type":96},50,"ESTIMATED","INTERVENTIONAL",[31],"The goal of this clinical trial is to evaluate a prototype wearable stethoscope designed to record lung sounds and assess asthma control in children and adolescents with asthma aged 4 to 17 years who are able to perform spirometry. The study aims to determine whether the prototype wearable stethoscope can accurately detect clinically meaningful changes in lung sounds associated with asthma control and response to bronchodilator treatment.\n\nThe main questions it aims to answer are:\n\n* Does the prototype wearable stethoscope demonstrate agreement with recordings obtained from commercially available Thinklabs One Digital Stethoscopes in identifying normal and abnormal lung sounds?\n* Are lung sounds detected by the prototype wearable stethoscope associated with asthma symptom control as measured by the Childhood Asthma Control Test (cACT) or Asthma Control Test (ACT)\n\nResearchers will compare recordings obtained from the prototype wearable stethoscope with recordings obtained from FDA-cleared Thinklabs One Digital Stethoscopes to evaluate the prototype device's ability to detect abnormal lung sounds and changes in lung sounds following bronchodilator treatment.",[101,102,103],"Asthma","Pediatric Asthma","Airway Obstruction Upper",[105,101,106],"Wearable Stethoscope","Lung Sound Monitoring","NOT_YET_RECRUITING","2026-08-25",{"date":110,"type":111},"2026-08-28","ACTUAL",{"date":113,"type":96},"2026-10-01",{"date":115,"type":96},"2027-12-31",{"name":5,"class":6},1]