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NCT Number: NCT06691971

AeviceMD 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.

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Key information

Conditions

Subject Presenting Wheeze Asthma Bronchial Disease Bronchial Diseases Chronic Respiratory Disease Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Lung Diseases Lung Diseases, Obstructive Pathological Conditions, Signs and Symptoms Pediatric Asthma Respiratory Hypersensitivity Respiratory Sounds Respiratory Tract Diseases Signs and Symptoms Signs and Symptoms, Respiratory

Age range

3 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Montefiore Medical Center

The Bronx, New York, 10467, United States

Location status: Recruiting

Location contact

Sunit P. Jariwala, Professor

CONTACT

[email protected]

718-920-6089

Sunit P. Jariwala, Professor

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

AeviceMD

Device

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

Other names: AeviceMD Monitoring System

Primary outcomes

  1. Wheeze is detected by physician and AeviceMD

    Time frame: 60 Seconds

    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.

Secondary outcomes

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

    Time frame: 150 Seconds

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

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

CONTACT

[email protected]

718-920-6626

Sunit P. Jariwala, Professor, M.D.

CONTACT

[email protected]

718-920-6089

Sponsors and collaborators

Lead sponsor

Aevice Health Pte. Ltd.

Other

Collaborators

  • Montefiore Medical Center

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Nov 18, 2024
Registry last updated
Oct 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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