AeviceMD for Detection of Wheeze in Pediatric and Adult Populations
Part of paid clinical trials in The Bronx, New York.
- Sponsor
- Aevice Health Pte. Ltd.
- Study ID
- NCT06691971
- Status
- Recruiting
Conditions
- Asthma
- Bronchial Disease
- Chronic Respiratory Disease
- Pediatric Asthma
- Respiratory Tract Diseases
- Subject Presenting Wheeze
Eligibility Criteria
- Sex
- ALL
- Age
- 3 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- AeviceMD — DEVICEThe AeviceMD device will be placed on the patient to detect the presence of wheeze and perform auscultation.
Study Details
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.
Key Dates
- Start date
- Jun 29, 2023
- Status verified
- Nov 2024
- Primary completion
- Dec 31, 2026
- Completion
- Dec 31, 2026
Study Design
- Enrollment
- 160 participants (estimated)
Arms
- Arm: Patients diagnosed with acute asthma exacerbationPatients diagnosed with acute asthma exacerbation
- Arm: Patient with a non-cardiac AND non-pulmonary chief complaint and discharge diagnosisPatient with a non-cardiac AND non-pulmonary chief complaint and discharge diagnosis
Primary Outcome Measure
Wheeze is detected by physician and AeviceMD [ Time Frame: 60 Seconds ]
Central Contacts
- Sunit P. Jariwala, Professor, M.D.718-920-6089
- Carlos L. Lutz, Assistant Professor, M.D.718-920-6626
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Montefiore Medical Center | The Bronx | New York | 10467 | Sunit P. Jariwala, Professor (PRINCIPAL_INVESTIGATOR) |
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