Wheeze Detection Using Aevice Medical Device

A Pilot Study to Assess Aevice Medical Device for Detection of Wheeze in Pediatric Subjects and Use for Remote Auscultation

The primary objective of this study is to determine if Aevice Medical Device can detect wheeze as accurately as a physician through auscultation. The secondary objective is to investigate if Aevice Medical Device can be used for remote auscultation of the lung.

Study Overview

• Status: Completed
• Conditions: Asthma; COPD; Subject Presenting Wheeze
• Intervention / Treatment: Device: AeviceMD

• Study Type: Observational
• Enrollment (Actual): 35

Contacts and Locations

Study Locations

• Singapore
  • Singapore, Singapore, 119074
    • National University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 3 years to 18 years (Child, Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Study will include 35 patients who are admitted for exacerbations of chronic airway disease (i.e. Asthma)

Description

Inclusion Criteria:

• The subject is willing and parents/guardians are able to give informed consent for participation in the study.
• Male or Female, aged 3 -18 years.
• Presenting with wheeze.
• Able (in the Investigators opinion) and willing to comply with all study requirements

Exclusion Criteria:

• Any other significant disease or disorder which, in the opinion of the Investigator, may either put the subjects at risk because of participation in the study, or may influence the result of the study, or the subject's ability to participate in the study.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Wheeze is detected by physician and AeviceMD	Primary end point of wheeze will be captured in a binary fashion (i.e. PRESENT or NOT PRESENT) on the CRF by the physician during manual auscultation. AeviceMD will perform wheeze analysis on each 5 sec of recording	60 Seconds

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Respiratory sounds are detected and identified by onsite physician and offsite (remote) physician	Secondary end point of normal, adventitious and lack of breath sounds will be captured in a binary fashion (i.e. PRESENT or NOT PRESENT) on the CRF by the physician during manual auscultation - i.e. bronchovesicular, crackles. Normal, adventitious and lack of breath sounds will be annotated in a binary fashion (i.e. PRESENT or NOT PRESENT) on the CRF by the independent physician during remote auscultation - i.e. bronchovesicular, crackles	150 Seconds

Collaborators and Investigators

• Sponsor: Aevice Health Pte. Ltd.
• Collaborators: National University Hospital, Singapore

Study record dates

Study Major Dates

• Study Start (Actual): April 23, 2021
• Primary Completion (Actual): July 18, 2023
• Study Completion (Actual): July 18, 2024

Study Registration Dates

• First Submitted: December 17, 2021
• First Submitted That Met QC Criteria: January 4, 2022
• First Posted (Actual): January 18, 2022

Study Record Updates

• Last Update Posted (Actual): June 4, 2025
• Last Update Submitted That Met QC Criteria: May 29, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Keywords: Auscultation; Wheeze
• Other Study ID Numbers: AE_MD_001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No