Asthma Lung Sounds With Wearable Stethoscope

Part of paid clinical trials in Los Angeles, California.

Sponsor: Children's Hospital Los Angeles
Study ID: NCT07792330
Status: Not Yet Recruiting

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Conditions

Airway Obstruction Upper
Asthma
Pediatric Asthma

Eligibility Criteria

Sex: ALL
Age: 4 Years - 17 Years
Healthy Volunteers: Not accepted

Interventions

Prototype Wearable Stethoscope — DEVICE
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.

Study Details

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.

Key Dates

First listed: Aug 28, 2026
Start date: Oct 1, 2026
Status verified: Aug 2026
Primary completion: Jul 30, 2027
Completion: Dec 31, 2027

Study Design

Enrollment: 50 participants (estimated)
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Arms

Experimental: Prototype Wearable Stethoscope Evaluation
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