Wearable Stethoscope for Childhood Asthma

DD
Overseen ByDanny Del Cid-Linares
Age: < 18
Sex: Any
Trial Phase: Academic
Sponsor: Children's Hospital Los Angeles
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

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?

RK

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

I am between 4 and 17 years old.
Assent (as applicable) and parental/legal guardian permission obtained
I am able to perform a breathing test (spirometry).
See 1 more

Exclusion Criteria

Unable to follow spirometry procedures
I am currently intubated.

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

Group I: Prototype Wearable Stethoscope EvaluationExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Children's Hospital Los Angeles

Lead Sponsor

Trials
257
Recruited
5,075,000+

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator

Trials
3,987
Recruited
47,860,000+

University of Southern California

Collaborator

Trials
956
Recruited
1,609,000+