NCT06791109

"SOUND" Trial: Study of On-site Use of Novel AI-assisted Diagnostics in CHD Screening

Efficacy Comparison Between Independent Auscultation by Primary Care Physicians and AI-Assisted Auscultation in Large-scale Screening for Congenital Heart Disease: A Cluster Randomized Controlled Trial in China

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 19,697 (actual)
• Sponsor: Kun Sun · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

This study plans to conduct clinical validation of the model in real clinical settings, comparing it with primary care physicians and specialist physicians to ensure the model's practicality. Through continuous optimization and practice, the study aims to use AI-assisted heart sound auscultation to empower the auscultation capabilities of primary care obstetricians, pediatricians, and non-cardiovascular specialists nationwide. This will not only reduce the missed diagnosis rate and improve the detection rate of existing CHD screenings, but also expand the coverage of current CHD screening networks, incorporating newborns, infants, preschool children, children, and adolescents aged 0-18 years into the screening scope. The study aims to establish a new benchmark in child health management by providing feasible and cost-effective child health management solutions for other developing countries, contributing to global efforts for the health of children.

Conditions

• Congenital Heart Disease (CHD)
• Screening Tool
• Artificial Intelligence (AI)
• Cluster Randomized Trial
• Auscultation for Clinical Evaluation

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Primary care physicians	For participants in Group A, a nonblinded independent staff member will first collect medical history, followed by sequential auscultation and CHD assessment by a specialist physician and a primary care physician, with an echocardiogram performed last.
DIAGNOSTIC_TEST	AI + Primary care physicians	For participants in Group B, after medical history collection, both a specialist physician and a primary care physician will perform auscultation and CHD assessment. Subsequently, the primary care physician will use an electronic stethoscope to collect heart sound data according to the protocol and upload the recordings to a cloud platform. The AI model will analyze the data on the cloud platform and provide a diagnostic result within 5-10 seconds for the primary care physician's reference. The primary care physician may reassess the findings based on the AI model's feedback, and the participant will then undergo an echocardiogram.

Timeline

• Start date: 2025-09-22
• Primary completion: 2025-11-18
• Completion: 2026-01-04
• First posted: 2025-01-24
• Last updated: 2026-04-07

Locations

1 site across 1 country: China