Subject Presenting WheezeNCT06691971
AeviceMD for Detection of Wheeze in Pediatric and Adult Populations
An observational study of Subject Presenting Wheeze and Asthma, run by Aevice Health Pte. Ltd. at 1 site in United States.
Trial summary
Respiratory signs and symptoms consisting of wheeze, cough, and breathlessness are obtained in a manual fashion through history taking and physical examination by the healthcare professional. Read more about this study
- Who is it for?
- Ages 3 years and older
- Conditions the study is for
- Subject Presenting Wheeze, Asthma, Bronchial Disease
- What is being tested?
- AeviceMD
- Type of treatment
- Medical device
- How many people
- 160 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Jun 2023to Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Study will include 160 Subjects (80 Pediatrics and 80 Adult Subjects) who are presenting with wheeze in the emergency department, and outpatient and inpatient settings
Who may be able to join
- The subject is willing and/or parents/guardians are able to give informed consent for participation in the study.
- Male or Female, aged ≥ 3 years.
- Diagnosed with acute asthma exacerbation by an ED provider.
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. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Montefiore Medical Center
The Bronx, New York, 10467
Sunit P. Jariwala, Professor, 718-920-6089, sjariwal@montefiore.org
Sunit P. Jariwala, Professor
About this study
Official title: A Pilot Study to Assess Aevice Medical Device for Detection of Wheeze in Pediatric and Adult Populations
Respiratory signs and symptoms consisting of wheeze, cough, and breathlessness are obtained in a manual fashion through history taking and physical examination by the healthcare professional. Auscultation of the lung assesses airflow through the trachea-bronchial tree and is helpful in diagnosing various respiratory disorders. AeviceMD is a wearable device that can acquire and process lung sounds, thus assisting in the detection of abnormal lung sounds. The primary objective of this study is to determine if AeviceMD can detect wheeze of pediatrics and adults as accurately as a physician through auscultation. The secondary objective is to investigate if AeviceMD can be used for remote auscultation of breath sounds.
- Conditions
- Subject Presenting Wheeze, Asthma, Bronchial Disease, Respiratory Tract Diseases, Pediatric Asthma, Chronic Respiratory Disease
- Being tested
- AeviceMD
- Keywords
- Wheeze, Auscultation, Wearable Medical Device
- Medical subject headings
- Asthma, Bronchial Diseases, Respiratory Tract Diseases, 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 device will be placed on the patient to detect the presence of wheeze and perform auscultation.
| Study group | Role | What they receive |
|---|---|---|
| Patients diagnosed with acute asthma exacerbation | Patients diagnosed with acute asthma exacerbation Receives: Device: AeviceMD | |
| Patient with a non-cardiac AND non-pulmonary chief complaint and discharge diagnosis | Patient with a non-cardiac AND non-pulmonary chief complaint and discharge diagnosis |
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 endpoint 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 endpoint of normal, abnormal and absent breath 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, abnormal and absent 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 Nov 2024
- Study start29 Jun 2023
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
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
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aevice Health Pte. Ltd.
- Sponsor type
- University, hospital or other
- Collaborators
- Montefiore Medical Center
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06691971
- Sponsor's protocol ID
- AE_MD_002
- Status last verified
- Nov 2024
- First submitted
- 14 Nov 2024
- Last updated
- 3 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 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 and Adult Populations
- ClinicalTrials.gov ID
- NCT06691971
- Acronym / sponsor ID
- AE_MD_002
- Conditions
- Subject Presenting Wheeze, Asthma, Bronchial Disease, Respiratory Tract Diseases, Pediatric Asthma, Chronic Respiratory Disease
- Keywords
- Wheeze, Auscultation, Wearable Medical Device
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- Aevice Health Pte. Ltd.University, hospital or other
- Collaborators
- Montefiore Medical Center
- Study start
- 29 Jun 2023 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 18 Nov 2024 (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.
Respiratory signs and symptoms consisting of wheeze, cough, and breathlessness are obtained in a manual fashion through history taking and physical examination by the healthcare professional. Auscultation of the lung assesses airflow through the trachea-bronchial tree and is helpful in diagnosing various respiratory disorders. AeviceMD is a wearable device that can acquire and process lung sounds, thus assisting in the detection of abnormal lung sounds. The primary objective of this study is to determine if AeviceMD can detect wheeze of pediatrics and adults as accurately as a physician through auscultation. The secondary objective is to investigate if AeviceMD can be used for remote auscultation of breath sounds.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients diagnosed with acute asthma exacerbation | – | Device: AeviceMDPatients diagnosed with acute asthma exacerbation |
| Patient with a non-cardiac AND non-pulmonary chief complaint and discharge diagnosis | – | –Patient with a non-cardiac AND non-pulmonary chief complaint and discharge diagnosis |
Who may qualify
- Ages
- 3 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Study will include 160 Subjects (80 Pediatrics and 80 Adult Subjects) who are presenting with wheeze in the emergency department, and outpatient and inpatient settings
Key inclusion criteria (3 listed)
- The subject is willing and/or parents/guardians are able to give informed consent for participation in the study.
- Male or Female, aged ≥ 3 years.
- Diagnosed with acute asthma exacerbation by an ED provider.
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 device will be placed on the patient to detect the presence of wheeze and perform auscultation. | Device | Patients diagnosed with acute asthma exacerbation |
Primary outcome
Wheeze is detected by physician and AeviceMD
Time frame: 60 Seconds
Primary endpoint 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
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Oct 2025.
- Individual participant dataSharing planned: Undecided
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.
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 Asthma, run by Aevice Health Pte. Ltd. at 1 site in United States.
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 3 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: looking for participants now, as of the sponsor's last update on 3 Oct 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 United States. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sunit P. Jariwala, Professor, M.D. (718-920-6089, sjariwal@montefiore.org), or a site near the patient. 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 3 Oct 2025.