RecruitingNCT06734793

Wearable Electronic Breath Sound Sensing Device

Pilot Study of Wearable Electronic Breath Sound Sensing Device for Monitoring of Breath Sounds in Pediatric Patients With Asthma


Sponsor

Emory University

Enrollment

25 participants

Start Date

Feb 26, 2025

Study Type

OBSERVATIONAL

Conditions

Summary

This study will assess the ability of a wearable stethoscope to monitor wheezing in high-risk asthma patients admitted at Children's Healthcare of Atlanta. This study is important to assist in the health management of patients with chronic lung diseases that can experience exacerbations leading to their health worsening and requiring hospitalization. The population that will be approached for this study will include 10 pediatric subjects hospitalized at Children's Healthcare of Atlanta for an asthma-related exacerbation. Participants will wear the patches for up to 8 hours on their chest and back wall from their date of consent until their hospital discharge. This may range from the participant taking part in 1 to 14 visits that could last up to 8 hours.


Eligibility

Min Age: 6 YearsMax Age: 17 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a wearable device that sticks to the chest and records breath sounds, to see if it can reliably detect worsening asthma in children during an acute episode. **You may be eligible if...** - Your child is between 6 and 17 years old - Your child has been diagnosed with persistent asthma - Your child is currently being treated for an acute asthma flare-up - You (the parent/guardian) can speak and understand English **You may NOT be eligible if...** - Your child was born prematurely - Your child has another chronic lung condition (such as cystic fibrosis, bronchiectasis, or primary ciliary dyskinesia) - Your child has a latex allergy or is allergic to medical tape - Your child uses a pacemaker, vagal nerve stimulator, or diaphragm pacing device Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEWearable stethoscope

The device is a soft, wearable stethoscope designed for continuous, comfortable monitoring of patients for abnormal breath sounds, such as wheezing, which can indicate asthma exacerbations. It automatically detects and diagnoses abnormal breath frequencies, wirelessly transmitting data for analysis. Preliminary materials have shown biocompatibility, ensuring the device is safe for use in children. A key feature is its machine-learning algorithm, which can classify and differentiate normal from abnormal sounds with an expected accuracy above 80%. Initial in vivo tests will compare the device's findings to those of a commercial-grade stethoscope in healthy subjects and individuals with asthma. Breath sound data will be used to improve the detection of wheezing sounds from these continuous recordings based on frequency and amplitude analysis of the recordings.

OTHERRoutine Clinical lung Auscultation

The study PI will auscultate the participant's lungs at enrollment to ensure that wheezing is present before beginning the continuous recording of the participant's lung sounds. The PI will assess the participant's respiratory status daily at the start of each breath sound recording session.


Locations(1)

Arthur M. Blank Hospital | Children's Healthcare of Atlanta

Atlanta, Georgia, United States

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NCT06734793


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