Wheeze Detection Using Aevice Medical Device

Active, not recruiting

• Conditions: Asthma; Subject Presenting Wheeze; COPD

• Registration Number: NCT05194436
• Lead Sponsor: AEvice Health Pte Ltd

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-04-23
• Study First Submitted: 2021-12-17
• Study First Submitted QC: 2022-01-04
• Study First Posted: 2022-01-18
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-10
• Last Update Posted: 2024-11-12
• Primary Completion: 2025-06
• Study Completion: 2025-06

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 35

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

National University Hospital; 🇸🇬 Singapore, Singapore