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.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts

Official record

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Trial summary

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

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.

Sunit P. Jariwala, Professor, M.D. contact

718-920-6089

sjariwal@montefiore.org

Carlos L. Lutz, Assistant Professor, M.D. contact

718-920-6626

clutz@montefiore.org

United States1 site, 1 recruiting

Montefiore Medical Center
The Bronx, New York, 10467
Sunit P. Jariwala, Professor, 718-920-6089, sjariwal@montefiore.org
Sunit P. Jariwala, Professor
Recruiting

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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 groups in NCT06691971
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.

29 Jun 2023Dec 2026

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)

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