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AeviceMD for Detection of Wheeze in Pediatric and Adult Populations

A

Aevice Health Pte. Ltd.

Status

Enrolling

Conditions

Chronic Respiratory Disease
Pediatric Asthma
Asthma
Respiratory Tract Diseases
Subject Presenting Wheeze
Bronchial Disease

Treatments

Device: AeviceMD

Study type

Observational

Funder types

Other

Identifiers

NCT06691971
AE_MD_002

Details and patient eligibility

About

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.

Enrollment

160 estimated patients

Sex

All

Ages

3+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

160 participants in 2 patient groups

Patients diagnosed with acute asthma exacerbation
Description:
Patients diagnosed with acute asthma exacerbation
Treatment:
Device: AeviceMD
Patient with a non-cardiac AND non-pulmonary chief complaint and discharge diagnosis
Description:
Patient with a non-cardiac AND non-pulmonary chief complaint and discharge diagnosis

Trial contacts and locations

1

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Central trial contact

Sunit P. Jariwala, Professor, M.D.; Carlos L. Lutz, Assistant Professor, M.D.

Data sourced from clinicaltrials.gov

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