NCT06691971 AeviceMD for Detection of Wheeze in Pediatric and Adult Populations
| NCT ID | NCT06691971 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Aevice Health Pte. Ltd. |
| Condition | Subject Presenting Wheeze |
| Study Type | OBSERVATIONAL |
| Enrollment | 160 participants |
| Start Date | 2023-06-29 |
| Primary Completion | 2026-12 |
Trial Parameters
Eligibility Fast-Check
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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.
Eligibility Criteria
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.