Subject Presenting WheezeNCT05194436
Wheeze Detection Using Aevice Medical Device
An observational study of Subject Presenting Wheeze and COPD, run by Aevice Health Pte. Ltd. at 1 site in Singapore.
Trial 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. Read more about this study
- Who is it for?
- Ages 3 to 18 years
- Conditions the study is for
- Subject Presenting Wheeze, COPD, Asthma
- What is being tested?
- AeviceMD
- Type of treatment
- Medical device
- How many people
- 35 participants
- Where
- 1 siteSingapore
- Study dates
- 23 Apr 2021to 18 Jul 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Study will include 35 patients who are admitted for exacerbations of chronic airway disease (i.e. Asthma)
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Pilot Study to Assess Aevice Medical Device for Detection of Wheeze in Pediatric Subjects and Use for Remote Auscultation
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
- Being tested
- AeviceMD
- Keywords
- Wheeze, Auscultation
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Asthma, Respiratory Sounds
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AeviceMDDevice
Also called AeviceMD Monitoring System
The AeviceMD will be placed on the patient to detect wheeze and perform auscultation.
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 150 Seconds
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2022
- Study start23 Apr 2021
- Primary completion18 Jul 2023
- Study completion18 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Subject Presenting WheezeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aevice Health Pte. Ltd.
- Sponsor type
- University, hospital or other
- Collaborators
- National University Hospital, Singapore
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05194436
- Sponsor's protocol ID
- AE_MD_001
- Status last verified
- May 2025
- First submitted
- 17 Dec 2021
- Last updated
- 4 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study to Assess Aevice Medical Device for Detection of Wheeze in Pediatric Subjects and Use for Remote Auscultation
- ClinicalTrials.gov ID
- NCT05194436
- Acronym / sponsor ID
- AE_MD_001
- Conditions
- Subject Presenting Wheeze, COPD, Asthma
- Keywords
- Wheeze, Auscultation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Aevice Health Pte. Ltd.University, hospital or other
- Collaborators
- National University Hospital, Singapore
- Study start
- 23 Apr 2021 (actual)
- Primary completion
- 18 Jul 2023 (actual)
- Study completion
- 18 Jul 2024 (actual)
- First posted
- 18 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 3 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Study will include 35 patients who are admitted for exacerbations of chronic airway disease (i.e. Asthma)
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AeviceMDAlso: AeviceMD Monitoring SystemThe AeviceMD will be placed on the patient to detect wheeze and perform auscultation. | Device | – |
Primary outcome
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
1 secondary outcome
Respiratory sounds are detected and identified by onsite physician and offsite (remote) physician
Time frame: 150 Seconds
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2025.
- Individual participant dataSharing planned: Undecided
Related trials for Subject Presenting Wheeze
RecruitingObservational study
AeviceMD for Detection of Wheeze in Pediatric and Adult Populations
Subject Presenting Wheeze, Asthma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Subject Presenting Wheeze and COPD, run by Aevice Health Pte. Ltd. at 1 site in Singapore.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Singapore. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Wheeze is detected by physician and AeviceMD (time frame: 60 Seconds). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jun 2025.