AeviceMD for Detection of Wheeze in Pediatric and Adult Populations

Recruiting

• Conditions: Subject Presenting Wheeze; Asthma; Bronchial Disease; Respiratory Tract Diseases; Pediatric Asthma; Chronic Respiratory Disease

• Registration Number: NCT06691971
• Lead Sponsor: Aevice Health Pte. Ltd.

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-06-29
• Status Verified: 2024-11
• Study First Submitted: 2024-11-14
• Study First Submitted QC: 2024-11-14
• Last Update Submitted: 2024-11-17
• Study First Posted: 2024-11-18
• Last Update Posted: 2024-11-20
• Primary Completion: 2025-06
• Study Completion: 2025-06

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 160

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Wheeze is detected by physician and AeviceMD	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 Outcome Measures

Name	Time	Method
Respiratory sounds are detected and identified by onsite physician and offsite (remote) physician	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.

Trial Locations

Locations (1)

Montefiore Medical Center; 🇺🇸 Bronx, New York, United States