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Completed

NCT Number: NCT06734793

Wearable Electronic Breath Sound Sensing Device

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.

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Key information

Conditions

Asthma in Children Asthma Attack

Age range

6 year–17 year

Sex eligibility

All sexes

Study type

Observational

Primary location

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

Atlanta, Georgia, 30329, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

Other names: Standard of Care

Primary outcomes

  1. Clinical Respiratory Score (CRS) change

    Time frame: 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 outcomes

  1. Detection of wheezing sounds by the wearable stethoscope

    Time frame: 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.

  2. Visual Erythema Assessment Scale (VEAS)

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Emory University

Other

Collaborators

  • Georgia Institute of Technology
  • Imlay Foundation

Registry information

Official study title

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

Acronym: WEBSS

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Dec 16, 2024
Registry last updated
Jul 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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