Actively Recruiting
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
Eligibility Criteria
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.
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
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
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
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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