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NCT Number: NCT07792330

Asthma Lung Sounds With Wearable Stethoscope

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.

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Key information

Age range

4 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Children's Hospital Los Angeles

Los Angeles, California, 90027, United States

Location contact

Danny Del Cid-Linares

CONTACT

[email protected]

3233611983

Roberta Kato, MD

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

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.

Primary outcomes

  1. Agreement Between Prototype Wearable Stethoscope and Thinklabs One Digital Stethoscope

    Time frame: Single study visit (up to 90 minutes).

    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.

  2. Association Between Lung Sounds and Asthma Control Scores

    Time frame: Single study visit (up to 90 minutes).

    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).

Secondary outcomes

  1. Sensitivity of Abnormal Lung Sound Detection

    Time frame: Single study visit (up to 90 minutes).

    Sensitivity of the prototype wearable stethoscope for detecting abnormal lung sounds compared with Thinklabs One Digital Stethoscope recordings

  2. Specificity of Abnormal Lung Sound Detection

    Time frame: Single study visit (up to 90 minutes).

    Specificity of the prototype wearable stethoscope for detecting abnormal lung sounds compared with Thinklabs One Digital Stethoscope recordings

  3. Positive Predictive Value (PPV)

    Time frame: Single study visit (up to 90 minutes).

    Positive predictive value of the prototype wearable stethoscope for identifying abnormal lung sounds compared with Thinklabs One Digital Stethoscope recordings.

  4. Negative Predictive Value (NPV)

    Time frame: Single study visit (up to 90 minutes).

    Negative predictive value of the prototype wearable stethoscope for identifying abnormal lung sounds compared with Thinklabs One Digital Stethoscope recordings.

Study contacts

Contact information is provided by the study sponsor or research team.

Danny Del Cid-Linares

CONTACT

[email protected]

310-445-0919

Sponsors and collaborators

Lead sponsor

Children's Hospital Los Angeles

Other

Collaborators

  • National Heart, Lung, and Blood Institute (NHLBI)
  • University of Southern California

Registry information

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Aug 28, 2026
Registry last updated
Aug 28, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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