An interventional study of Prototype Wearable Stethoscope in Asthma, Pediatric Asthma and Airway Obstruction Upper, sponsored by Children's Hospital Los Angeles. Not yet recruiting at 1 site in United States. Open to participants aged 4 Years to 17 Years. Per ClinicalTrials.gov, last updated 2026-08-28.
Sponsored by Children's Hospital Los Angeles · Not applicable, Interventional, and Diagnostic
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.
The main questions it aims to answer are:
Researchers 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.
4,841 studies on the registry are indexed under Asthma; 600 are open to participants now.
This study's planned enrollment of 50 is below the median of 78 across 3,341 interventional studies indexed under Asthma.
Browse Asthma studies →Children's Hospital Los Angeles is the lead sponsor of 152 studies on the registry; 46 are open to participants now.
Of its 9 completed or terminated interventional studies of FDA-regulated products, 6 (67%) have results posted.
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Exclusion Criteria:
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
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.
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.
Time frame: Single study visit (up to 90 minutes).
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).
Time frame: Single study visit (up to 90 minutes).
Sensitivity of Abnormal Lung Sound Detection
Sensitivity of the prototype wearable stethoscope for detecting abnormal lung sounds compared with Thinklabs One Digital Stethoscope recordings
Time frame: Single study visit (up to 90 minutes).
Specificity of Abnormal Lung Sound Detection
Specificity of the prototype wearable stethoscope for detecting abnormal lung sounds compared with Thinklabs One Digital Stethoscope recordings
Time frame: Single study visit (up to 90 minutes).
Positive Predictive Value (PPV)
Positive predictive value of the prototype wearable stethoscope for identifying abnormal lung sounds compared with Thinklabs One Digital Stethoscope recordings.
Time frame: Single study visit (up to 90 minutes).
Negative Predictive Value (NPV)
Negative predictive value of the prototype wearable stethoscope for identifying abnormal lung sounds compared with Thinklabs One Digital Stethoscope recordings.
Time frame: Single study visit (up to 90 minutes).
Plan to share: No
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This study is not yet recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
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