Wearable Stethoscope for Childhood Asthma
What You Need to Know Before You Apply
What is the purpose of this trial?
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:
* Does the prototype wearable stethoscope demonstrate agreement with recordings obtained from commercially available Thinklabs One Digital Stethoscopes in identifying normal and abnormal lung sounds?
* 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)
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.
Who Is on the Research Team?
Roberta Kato, MD
Principal Investigator
Children's Hospital Los Angeles
Are You a Good Fit for This Trial?
This trial is for children and teens aged 4 to 17 years who have asthma and are able to perform a breathing test called spirometry.Inclusion Criteria
Exclusion Criteria
What Are the Treatments Tested in This Trial?
Interventions
- Prototype Wearable Stethoscope
Trial Overview
The study is testing a new wearable stethoscope that records lung sounds. It will be compared with an existing digital stethoscope to see if it can accurately detect changes in lung sounds related to asthma control and treatment response.
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
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
Find a Clinic Near You
Who Is Running the Clinical Trial?
Children's Hospital Los Angeles
Lead Sponsor
National Heart, Lung, and Blood Institute (NHLBI)
Collaborator
University of Southern California
Collaborator
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