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CompletedNCT05194436Updated Jun 4, 2025

Wheeze Detection Using Aevice Medical Device

An observational study in Subject Presenting Wheeze, COPD and Asthma, sponsored by Aevice Health Pte. Ltd.. Completed at 1 site in Singapore. Open to participants aged 3 Years to 18 Years. Per ClinicalTrials.gov, last updated 2025-06-04.

Sponsored by Aevice Health Pte. Ltd. · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
35
Ages
3 Years to 18 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Subject Presenting Wheeze
  • COPD
  • Asthma

Keywords

  • Wheeze
  • Auscultation
03

In context

Lead sponsor

Aevice Health Pte. Ltd. is the lead sponsor of 2 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
3 Years to 18 Years
Sexes eligible
All
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)

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

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.
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
35 participants (actual)
Patient registry
No

Interventions

  • DeviceAeviceMD

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

    Also known as: AeviceMD Monitoring System

06

What researchers measure

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

    Time frame: 60 Seconds

Secondary outcomes

  1. 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

    Time frame: 150 Seconds

07

Study locations

1 site
  • National University Hospital
    Singapore, 119074, Singapore
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 4, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05194436
Lead sponsor
Aevice Health Pte. Ltd.
Collaborators
National University Hospital, Singapore
Responsible party
Sponsor
First posted
Jan 18, 2022
Start date
Apr 23, 2021
Primary completion
Jul 18, 2023
Completion
Jul 18, 2024
Last update
Jun 4, 2025

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2025. You cannot join it, but the record below documents what was studied.

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