Wearable Electronic Breath Sound Sensing Device
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age6-17
SponsorEmory University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age 6-17 years
Diagnosis of persistent asthma
Being treated for an acute asthma exacerbation
Parent can speak and understand English
Disqualifiers
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
Trial population
Pediatric patients with asthma between the ages of 6-17 years who are being treated for an acute asthma exacerbation in the hospital.
Trial design
Design model
Cohort
Time perspective
Cross-sectional
Treatments tested in this trial
Wearable stethoscope
DeviceThe 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 interventionThe 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.
Treatment groups
25 Participants
are divided into 1 treatment groupGroup A: Pediatric patients with asthma2 interventions
Trial outcomes
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.
Time frame
Star of each recording session, end of each recording session up to 14 daysSecondary outcomes
1
Detection of wheezing sounds by the wearable stethoscope
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.
Time frame
Throughout study participation until hospital discharge (up to 14 days)2
Visual Erythema Assessment Scale (VEAS)
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.
Time frame
At the end of each recording session up until hospital discharge (up to 14 days)Sponsors and contacts
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Source ClinicalTrials.gov