Asthma Lung Sounds With Wearable Stethoscope
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age4-17
SponsorChildren's Hospital Los Angeles
About 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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Children and adolescents aged 4 to 17 years
Diagnosis of asthma
Ability to perform spirometry
Assent (as applicable) and parental/legal guardian permission obtained
Disqualifiers
Unable to follow spirometry procedures
Intubated at the time of enrollment
Trial design
Design model
Single group
Treatments tested in this trial
Prototype Wearable Stethoscope
DeviceThe 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.
Treatment groups
50 Participants
are divided into 1 treatment groupGroup A: Prototype Wearable Stethoscope EvaluationExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
Single study visit (up to 90 minutes).2
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).
Time frame
Single study visit (up to 90 minutes).Secondary outcomes
1
Sensitivity of Abnormal Lung Sound Detection
Sensitivity of the prototype wearable stethoscope for detecting abnormal lung sounds compared with Thinklabs One Digital Stethoscope recordings
Time frame
Single study visit (up to 90 minutes).2
Specificity of Abnormal Lung Sound Detection
Specificity of the prototype wearable stethoscope for detecting abnormal lung sounds compared with Thinklabs One Digital Stethoscope recordings
Time frame
Single study visit (up to 90 minutes).3
Positive Predictive Value (PPV)
Positive predictive value of the prototype wearable stethoscope for identifying abnormal lung sounds compared with Thinklabs One Digital Stethoscope recordings.
Time frame
Single study visit (up to 90 minutes).4
Negative Predictive Value (NPV)
Negative predictive value of the prototype wearable stethoscope for identifying abnormal lung sounds compared with Thinklabs One Digital Stethoscope recordings.
Time frame
Single study visit (up to 90 minutes).Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Children's Hospital Los Angeles
Lead sponsor
National Heart, Lung, and Blood Institute (NHLBI)
Collaborator
University of Southern California
Collaborator
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: