Clinical trial NCT06734793: Wearable Electronic Breath Sound Sensing Device
Official title: Pilot Study of Wearable Electronic Breath Sound Sensing Device for Monitoring of Breath Sounds in Pediatric Patients with Asthma
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Asthma in Children
Asthma Attack
Keywords: Hospital admission
Wearable stethoscope
Asthma Exacerbations
Lead sponsor: Emory University
Sponsor class: OTHER
Collaborators: name: Georgia Institute of Technology
name: Imlay Foundation
First posted: 2024-12-16
Enrollment: 10
Sex: ALL
Minimum age (years): 6
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
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.

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.

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

Primary outcomes:
measure: Clinical Respiratory Score (CRS) change
timeFrame: Star of each recording session, end of each recording session up to 14 days
Secondary outcomes:
measure: Detection of wheezing sounds by the wearable stethoscope
timeFrame: Throughout study participation until hospital discharge (up to 14 days)
measure: Visual Erythema Assessment Scale (VEAS)
timeFrame: At the end of each recording session up until hospital discharge (up to 14 days)
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Arthur M. Blank Hospital | Children's Healthcare of Atlanta
state: Georgia
Study officials:
affiliation: Emory University
name: Lokesh Guglani, MD
role: PRINCIPAL_INVESTIGATOR
References: