Wheeze Detection Using Aevice Medical Device

NCT05194436 | Completed

• 1 other identifier: AE_MD_001
• Study Type: observational
• Target: 35
• Locations: 1 country
• Sites: 1

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.

Conditions

Subject Presenting Wheeze; COPD; Asthma

Keywords

Wheeze; Auscultation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

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

  150 Seconds

Interventions

AeviceMD DEVICE

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

Also known as: AeviceMD Monitoring System

Eligibility Criteria

• Age: 3 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Aevice Health Pte. Ltd.: lead
• National University Hospital, Singapore: collaborator

Study Sites (1)

National University Hospital

Singapore, Singapore, 119074, Singapore

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Asthma; Respiratory Sounds

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Bronchial Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 17, 2021
• First Posted: January 18, 2022
• Study Start: April 23, 2021
• Primary Completion: July 18, 2023
• Study Completion: July 18, 2024
• Last Updated: June 4, 2025

Record last verified: 2025-05

Locations

SG (1)