Asthma Lung Sounds With Wearable Stethoscope

NCT07792330 | Not Yet Recruiting FDA Device

• 2 other identifiers: CHLA-25-000885R01HL165138
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Asthma; Pediatric Asthma; Airway Obstruction Upper

Keywords

Wearable Stethoscope; Asthma; Lung Sound Monitoring

Outcome Measures

Primary Outcomes (2)

• 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).

• 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).

  Single study visit (up to 90 minutes).

Secondary Outcomes (4)

• Sensitivity of Abnormal Lung Sound Detection

  Single study visit (up to 90 minutes).

• Specificity of Abnormal Lung Sound Detection

  Single study visit (up to 90 minutes).

• Positive Predictive Value (PPV)

  Single study visit (up to 90 minutes).

• Negative Predictive Value (NPV)

  Single study visit (up to 90 minutes).

Study Arms (1)

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

Device: Prototype Wearable Stethoscope

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.

Prototype Wearable Stethoscope Evaluation

Eligibility Criteria

• Age: 4 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Children and adolescents aged 4 to 17 years
• Diagnosis of asthma
• Ability to perform spirometry
• Assent (as applicable) and parental/legal guardian permission obtained

You may not qualify if:

• Unable to follow spirometry procedures
• Intubated at the time of enrollment

Sponsors & Collaborators

• Children's Hospital Los Angeles: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator
• University of Southern California: collaborator

Study Sites (1)

Children's Hospital Los Angeles

Los Angeles, California, 90027, United States

Location

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Roberta Kato, MD

  Children's Hospital Los Angeles

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Danny Del Cid-Linares

CONTACT

310-445-0919; ddelcidlinares@chla.usc.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Staff/USC Faculty CWR

Study Record Dates

• First Submitted: August 25, 2026
• First Posted: August 28, 2026
• Study Start (Estimated): October 1, 2026
• Primary Completion (Estimated): July 30, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: August 28, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)