Wearable Electronic Breath Sound Sensing Device

Recruiting

• Conditions: Asthma in Children; Asthma Attack

• Registration Number: NCT06734793
• Lead Sponsor: Emory University

Brief 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.

Detailed Description

The main goal of this study is to evaluate the ability of a novel wearable breath sound sensor (wearable stethoscope) to continuously monitor breath sounds, specifically wheezing, in pediatric asthma patients during hospital admission. The data collected will be used to develop a wheeze detection algorithm. The breath sound recordings from this device will not be used for any medical decision-making or treatment changes, and all study participants will continue to receive routine medical management per standard of care guidelines.

Study Timeline

• Study First Submitted: 2024-12-11
• Study First Submitted QC: 2024-12-11
• Study First Posted: 2024-12-16
• Study Start: 2025-02-26
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-17
• Last Update Posted: 2025-03-18
• Primary Completion: 2026-03-01
• Study Completion: 2026-03-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

• Age 6-17 years
• Diagnosis of persistent asthma
• Being treated for an acute asthma exacerbation
• Parent can speak and understand English

Exclusion Criteria

• Unable to provide consent for the study
• History of prematurity
• History of other chronic lung conditions - cystic fibrosis, bronchiectasis, or primary ciliary dyskinesia
• History of latex allergy or allergy to medical tape adhesive
• Patients currently using another medical device - implanted pacemaker or vagal nerve stimulator or diaphragm pacing device

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Clinical Respiratory Score (CRS) change	Star of each recording session, end of each recording session up to 14 days	CRS is a 12-point assessment used to evaluate respiratory distress in hospitalized patients and guide treatment for asthma and bronchiolitis. It measures factors such as respiratory rate, work of breathing, wheezing, hypoxia, dyspnea, and cough. The change in CRS score will be recorded at the beginning and end of each session and later correlated with changes in breath sound recordings from the device. The absolute change in CRS will be correlated with changes in the breath sound recordings.

Secondary Outcome Measures

Name	Time	Method
Detection of wheezing sounds by the wearable stethoscope	Throughout study participation until hospital discharge (up to 14 days)	Detection of wheezing using convolutional neural networks and testing the wearable stethoscope's reliability against wheezing detected by medical providers during the participants' hospital stay until discharge up to 14 days.
Visual Erythema Assessment Scale (VEAS)	At the end of each recording session up until hospital discharge (up to 14 days)	VEAS will be used to assess skin changes after the recording is completed. VEAS evaluates the degree of erythema (redness) on the skin, which is often an indicator of inflammation or irritation. The scoring is based on visual observation, focusing on the intensity and extent of redness, with scores ranging from 0 (no reaction) to 9 (most intense reaction). Higher scores indicate more severe redness or inflammation.

Trial Locations

Locations (1)

Arthur M. Blank Hospital | Children's Healthcare of Atlanta; 🇺🇸 Atlanta, Georgia, United States