Recruiting

AeviceMD

Sponsor:

Aevice Health Pte. Ltd.

Code:

NCT06691971

Conditions

Subject Presenting Wheeze

Asthma

Bronchial Disease

Respiratory Tract Diseases

Pediatric Asthma

Eligibility Criteria

Sex: All

Age: 3+

Healthy Volunteers: Not accepted

Interventions

AeviceMD

Study Details

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

Study ID

NCT06691971

Start date

Jun 29, 2023

Status verified date

Nov, 2024

Completion date

Dec, 2026

Anticipated

Primary completion date

Dec, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 3+

Healthy Volunteers: Not accepted

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 Design

Enrollment

160 participants

Anticipated

Interventions and Outcome Measures

Arms

Patients diagnosed with acute asthma exacerbation

Patients diagnosed with acute asthma exacerbation

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

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

Primary outcome measure

  • Wheeze is detected by physician and AeviceMD [ Time Frame: 60 Seconds ]

Central Contacts and Locations

Central contacts

Sunit P. Jariwala, Professor, M.D.

718-920-6089sjariwal@montefiore.org

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

718-920-6626clutz@montefiore.org

Locations

Montefiore Medical Center

Recruiting

The Bronx, New York, United States, 10467

Contacts

Sunit P. Jariwala, Professor

718-920-6089sjariwal@montefiore.org

Principal Investigator:

Sunit P. Jariwala, Professor

More Information

Sponsor

Aevice Health Pte. Ltd.

Last update posted

Oct 3, 2025

Last verified

Nov, 2024

Keywords

  • Wheeze
  • Auscultation
  • Wearable Medical Device

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Aevice Health Pte. Ltd. on 2025-10-03.