Wearable Electronic Breath Sound Sensing Device

Conditions

• Asthma Attack
• Asthma in Children

Eligibility Criteria

Sex

ALL

Age

6 Years - 17 Years

Healthy Volunteers

Not accepted

Interventions

• 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.

Study Details

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.

Key Dates

Start date

Feb 26, 2025

Status verified

Mar 2026

Primary completion

Jul 1, 2026

Completion

Dec 31, 2026

Study Design

Enrollment

25 participants (estimated)

Arms

• Arm: Pediatric patients with asthma
  The study participants will be asked to wear up to a total of 5 patches in the following locations: left upper chest for the left upper lobe, left lower back for left lower lobe, right upper chest for the right upper lobe, right middle chest for the right middle lobe, and right lower back for the right lower lobe of the lung.

Primary Outcome Measure

Clinical Respiratory Score (CRS) change [ Time Frame: Star of each recording session, end of each recording session up to 14 days ]

Central Contacts

• Lokesh Guglani, MD
  404-712-2324
  [email protected]

Locations (1)

Find similar trials in Atlanta, GA

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