Wearable Electronic Breath Sound Sensing Device

NCT ID: NCT06734793

Last Updated: 2025-03-18

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 10 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-02-26
• Study Completion Date: 2026-03-01

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.

Conditions

Asthma in Children; Asthma Attack

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

Pediatric patients with asthma

The study participants will be asked to wear up to a total of 5 patches in the following locations: left upper chest for the left upper lobe, left lower back for left lower lobe, right upper chest for the right upper lobe, right middle chest for the right middle lobe, and right lower back for the right lower lobe of the lung.

Wearable stethoscope

Intervention Type: DEVICE

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.

Routine Clinical lung Auscultation

Intervention Type: OTHER

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.

Interventions

Wearable 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.

Intervention Type: DEVICE

Routine 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.

Intervention Type: OTHER

Other Intervention Names

Standard of Care

Eligibility Criteria

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

• Minimum Eligible Age: 6 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Georgia Institute of Technology

OTHER

Sponsor Role: collaborator

Imlay Foundation

UNKNOWN

Sponsor Role: collaborator

Emory University

OTHER

Sponsor Role: lead

Responsible Party

Lokesh Guglani

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Lokesh Guglani, MD

Role: PRINCIPAL_INVESTIGATOR

Emory University

Locations

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

Atlanta, Georgia, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Lokesh Guglani, MD

Role: CONTACT

lokesh.guglani@emory.edu

404-712-2324

Facility Contacts

Lokesh Guglani, MD

Role: primary

lokesh.guglani@emory.edu

404-712-2324

Other Identifiers

STUDY00007232

Identifier Type: -

Identifier Source: org_study_id