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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05194436

Enrollment

Registered

2022-01-18

Start date

2021-04-23

Completion date

2024-07-18

Last updated

2025-06-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Asthma, COPD, Subject Presenting Wheeze

Keywords

Wheeze, Auscultation

Brief summary

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.

Interventions

DEVICEAeviceMD

The AeviceMD will be placed on the patient to detect wheeze and perform auscultation.

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

3 Years to 18 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
Wheeze is detected by physician and AeviceMD	60 Seconds	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

Secondary

Measure	Time frame	Description
Respiratory sounds are detected and identified by onsite physician and offsite (remote) physician	150 Seconds	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

Countries

Singapore

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026