Airway Obstruction Upper, Asthma, Pediatric Asthma
Conditions
Keywords
Wearable Stethoscope, Asthma, Lung Sound Monitoring
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.
Interventions
DEVICEPrototype Wearable Stethoscope
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.
Sponsors
Children's Hospital Los Angeles
National Heart, Lung, and Blood Institute (NHLBI)
University of Southern California
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
4 Years to 17 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Agreement Between Prototype Wearable Stethoscope and Thinklabs One Digital Stethoscope | 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. |
| Association Between Lung Sounds and Asthma Control Scores | 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
| Measure | Time frame | Description |
|---|---|---|
| Sensitivity of Abnormal Lung Sound Detection | 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 |
| Specificity of Abnormal Lung Sound Detection | 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 |
| Positive Predictive Value (PPV) | 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. |
| Negative Predictive Value (NPV) | 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. |
Countries
United States
Contacts
CONTACTDanny Del Cid-Linares
PRINCIPAL_INVESTIGATORRoberta Kato, MD
Children's Hospital Los Angeles
Outcome results
None listed