AeviceMD for Detection of Wheeze in Pediatric and Adult Populations

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

160 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-06-29

Study Completion Date

2026-12-31

Brief Summary

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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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Detailed Description

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Conditions

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

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Patients diagnosed with acute asthma exacerbation

AeviceMD

Intervention Type DEVICE

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

Patient with a non-cardiac AND non-pulmonary chief complaint and discharge diagnosis

No interventions assigned to this group

Interventions

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AeviceMD

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

Intervention Type DEVICE

Other Intervention Names

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AeviceMD Monitoring System

Eligibility Criteria

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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.

Minimum Eligible Age

3 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No