AeviceMD for Detection of Wheeze in Pediatric and Adult Populations

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.

Study Overview

• Status: Recruiting
• Conditions: Respiratory Tract Diseases; Asthma; Chronic Respiratory Disease; Pediatric Asthma; Bronchial Disease; Subject Presenting Wheeze
• Intervention / Treatment: Device: AeviceMD

• Study Type: Observational
• Enrollment (Estimated): 160

Contacts and Locations

• Study Contact: Name: Sunit P. Jariwala, Professor, M.D.; Phone Number: 718-920-6089; Email: sjariwal@montefiore.org
• Study Contact Backup: Name: Carlos L. Lutz, Assistant Professor, M.D.; Phone Number: 718-920-6626; Email: clutz@montefiore.org

Study Locations

• United States
  • New York
    • The Bronx, New York, United States, 10467
      • Recruiting
      • Montefiore Medical Center
      • Contact: Sunit P. Jariwala, Professor; Phone Number: 718-920-6089; Email: sjariwal@montefiore.org
      • Principal Investigator: Sunit P. Jariwala, Professor

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

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

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patients diagnosed with acute asthma exacerbation	Device: AeviceMD; The AeviceMD device will be placed on the patient to detect the presence of wheeze and perform auscultation.; Other Names: AeviceMD Monitoring System
Patient with a non-cardiac AND non-pulmonary chief complaint and discharge diagnosis	Device: AeviceMD; The AeviceMD device will be placed on the patient to detect the presence of wheeze and perform auscultation.; Other Names: AeviceMD Monitoring System

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	60 Seconds

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	150 Seconds

Collaborators and Investigators

• Sponsor: Aevice Health Pte. Ltd.
• Collaborators: Montefiore Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): June 29, 2023
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: November 14, 2024
• First Submitted That Met QC Criteria: November 14, 2024
• First Posted (Actual): November 18, 2024

Study Record Updates

• Last Update Posted (Estimated): October 3, 2025
• Last Update Submitted That Met QC Criteria: September 30, 2025
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Keywords: Auscultation; Wheeze; Wearable Medical Device
• Additional Relevant MeSH Terms: Immune System Diseases; Lung Diseases; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Signs and Symptoms, Respiratory; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Asthma; Respiratory Tract Diseases; Bronchial Diseases; Respiratory Sounds
• Other Study ID Numbers: AE_MD_002

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No