Actively Recruiting

Age: 6Years - 17Years
All Genders
ID06734793

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

Led by Emory University · Updated on 2026-03-25

25

Participants Needed

1

Research Sites

26 weeks

Total Duration

On this page

Sponsors

E

Emory University

Lead Sponsor

G

Georgia Institute of Technology

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are evaluating a wearable electronic breath sound sensing device designed to continuously monitor breath sounds, especially wheezing, in children aged 6 to 17 years who are hospitalized with asthma exacerbations. This observational study aims to develop a wheeze detection algorithm using data collected from pediatric patients admitted for acute asthma attacks. The study focuses on improving health management for children with chronic lung diseases that may worsen and require hospital care. Participants will wear up to five patches placed on specific chest and back locations corresponding to different lung lobes. These patches collect breath sounds for up to 8 hours per session, from consent until hospital discharge, which may last from 1 to 14 visits. The wearable stethoscope wirelessly transmits data and uses a machine-learning algorithm to classify breath sounds. Routine clinical lung auscultation will also be performed by the principal investigator to confirm wheezing at enrollment and monitor respiratory status daily. During the study, participants will be monitored through breath sound recordings and clinical assessments, including the Clinical Respiratory Score and Visual Erythema Assessment Scale at each recording session. The device's recordings will not influence medical treatment, and all participants will continue to receive standard asthma care. The study will track changes over up to 14 days or until hospital discharge, with data used to improve wheeze detection accuracy and understand breath sound patterns during asthma exacerbations.

CONDITIONS

Brief Title

Wearable Electronic Breath Sound Sensing Device

Who Can Participate

Age: 6Years - 17Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 6 to 17 years
  • Diagnosis of persistent asthma
  • Being treated for an acute asthma exacerbation
  • Parent can speak and understand English
Not Eligible

You will not qualify if you...

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

AI-Screening

AI-Powered Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Monitoring

Duration - Up to 14 days or until hospital discharge

Participants wear a novel wearable electronic breath sound sensing device continuously during their hospital admission to monitor breath sounds, including wheezing. Routine clinical lung auscultation is performed daily by the study investigator to assess respiratory status at the start of each recording session. Participants continue to receive standard medical care for asthma throughout the study.

Daily recording sessions during hospital stay

Trial Site Locations

Total: 1 location

1

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

Atlanta, Georgia, United States, 30329

Actively Recruiting

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Research Team

L

Lokesh Guglani, MD

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

1

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