AeviceMD for Detection of Wheeze in Pediatric and Adult Populations

NCT06691971 | Recruiting FDA Device

• 1 other identifier: AE_MD_002
• Study Type: observational
• Target: 160
• Locations: 1 country
• Sites: 1

Brief 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. 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

Keywords

Wheeze; Auscultation; Wearable Medical Device

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Respiratory sounds are detected and identified by onsite physician and offsite (remote) physician

  150 Seconds

Study Arms (2)

Patients diagnosed with acute asthma exacerbation

Patients diagnosed with acute asthma exacerbation

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

Interventions

AeviceMD DEVICE

The AeviceMD device will be placed on the patient to detect the presence of wheeze and perform auscultation.

Also known as: AeviceMD Monitoring System

Patients diagnosed with acute asthma exacerbation

Eligibility Criteria

• Age: 3 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Aevice Health Pte. Ltd.: lead
• Montefiore Medical Center: collaborator

Study Sites (1)

Montefiore Medical Center

The Bronx, New York, 10467, United States

RECRUITING

MeSH Terms

Conditions

Asthma; Bronchial Diseases; Respiratory Tract Diseases; Respiratory Sounds

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

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

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 14, 2024
• First Posted: November 18, 2024
• Study Start: June 29, 2023
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: October 3, 2025

Record last verified: 2024-11

Locations

US (1)