Actively Recruiting

Age: 3Years +
All Genders
ID06691971

A Pilot Study to Assess Aevice Medical Device for Detection of Wheeze in Pediatric and Adult Populations

Led by Aevice Health Pte. Ltd. · Updated on 2025-10-03

160

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

Sponsors

A

Aevice Health Pte. Ltd.

Lead Sponsor

M

Montefiore Medical Center

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are evaluating the ability of the AeviceMD, a wearable medical device, to detect wheezing in both children and adults. Wheezing, cough, and breathlessness are common respiratory symptoms usually identified manually by healthcare professionals through listening to lung sounds. The study aims to find out if AeviceMD can detect wheezes as accurately as a physician and to explore its potential for remote lung sound monitoring. During the study, participants will have the AeviceMD device placed on them to record lung sounds and detect wheezes. The device's findings will be compared with assessments made by physicians through traditional auscultation. The study includes two groups: patients diagnosed with acute asthma exacerbations and patients with other non-cardiac and non-pulmonary complaints. Participants will undergo lung sound recordings both onsite with a physician and remotely, with the results compared between the AeviceMD device and medical professionals. The primary outcome is the detection of wheeze within 60 seconds, while the secondary outcome involves identifying respiratory sounds within 150 seconds. The study is observational and will continue until December 2026, involving children aged 3 years and older.

CONDITIONS

Brief Title

AeviceMD for Detection of Wheeze in Pediatric and Adult Populations

Who Can Participate

Age: 3Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • The subject is willing and/or parents/guardians are able to give informed consent for participation in the study.
  • Male or Female, aged 23 3 years.
  • Diagnosed with acute asthma exacerbation by an ED provider.
Not Eligible

You will not qualify if you...

  • 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.

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

Implementation

Duration - Single session

Participants have the AeviceMD device placed to detect wheeze and perform auscultation.

1 visit (in-person)

Trial Site Locations

Total: 1 location

1

Montefiore Medical Center

The Bronx, New York, United States, 10467

Actively Recruiting

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Research Team

S

Sunit P. Jariwala, Professor, M.D.

C

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

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

2

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