Wearable Electronic Breath Sound Sensing Device

NCT06734793 | Recruiting

• 2 other identifiers: STUDY000072322025P009892
• Study Type: observational
• Target: 25
• Locations: 1 country
• Sites: 1

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.

Conditions

Asthma in Children; Asthma Attack

Keywords

Hospital admission; Wearable stethoscope; Asthma Exacerbations

Outcome Measures

Primary Outcomes (1)

• Clinical Respiratory Score (CRS) change

  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.

  Star of each recording session, end of each recording session up to 14 days

Secondary Outcomes (2)

• Detection of wheezing sounds by the wearable stethoscope

  Throughout study participation until hospital 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)

Study Arms (1)

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.

Device: Wearable stethoscope; Other: Routine Clinical lung Auscultation

Interventions

Wearable stethoscope 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.

Pediatric patients with asthma

Routine Clinical lung Auscultation 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.

Also known as: Standard of Care

Pediatric patients with asthma

Eligibility Criteria

• Age: 6 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Probability Sample

Study Population

Pediatric patients with asthma between the ages of 6-17 years who are being treated for an acute asthma exacerbation in the hospital.

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Emory University: lead
• Georgia Institute of Technology: collaborator
• Imlay Foundation: collaborator

Study Sites (1)

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

Atlanta, Georgia, 30329, United States

RECRUITING

MeSH Terms

Interventions

Standard of Care

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Lokesh Guglani, MD

  Emory University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lokesh Guglani, MD

CONTACT

404-712-2324; lokesh.guglani@emory.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: December 11, 2024
• First Posted: December 16, 2024
• Study Start: February 26, 2025
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: March 25, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Time Frame: Data will be published in the form of a peer-reviewed manuscript by the end of 2025.

Locations

US (1)