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OpenTrials
Completed

NCT Number: NCT05194436

Wheeze Detection Using Aevice Medical Device

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.

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Key information

Conditions

Subject Presenting Wheeze Asthma Bronchial Diseases COPD Chronic Disease Disease Attributes Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Lung Diseases Lung Diseases, Obstructive Pathologic Processes Pathological Conditions, Signs and Symptoms Pulmonary Disease, Chronic Obstructive Respiratory Hypersensitivity Respiratory Sounds Respiratory Tract Diseases Signs and Symptoms Signs and Symptoms, Respiratory

Age range

3 year–18 year

Sex eligibility

All sexes

Study type

Observational

Primary location

National University Hospital

Singapore, 119074

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

AeviceMD

Device

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

Other names: AeviceMD Monitoring System

Primary outcomes

  1. Wheeze is detected by physician and AeviceMD

    Time frame: 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 outcomes

  1. Respiratory sounds are detected and identified by onsite physician and offsite (remote) physician

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Aevice Health Pte. Ltd.

Other

Collaborators

  • National University Hospital, Singapore

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2023
Study completion
2024
First posted
Jan 18, 2022
Registry last updated
Jun 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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