Ignite Creation Date:
2025-12-25 @ 1:11 AM
Ignite Modification Date:
2025-12-27 @ 3:05 AM
Study NCT ID:
NCT06734793
Status:
RECRUITING
Last Update Posted:
2025-03-18
First Post:
2024-12-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Wearable Electronic Breath Sound Sensing Device
Sponsor:
Emory University
Organization:
Study Overview
Official Title:
Pilot Study of Wearable Electronic Breath Sound Sensing Device for Monitoring of Breath Sounds in Pediatric Patients with Asthma
Status:
RECRUITING
Status Verified Date:
2025-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
WEBSS
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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
True
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?: