"SOUND" Trial: Study of On-site Use of Novel AI-assisted Diagnostics in CHD Screening (NCT06791109) | Clinical Trial Compass
CompletedNot Applicable
"SOUND" Trial: Study of On-site Use of Novel AI-assisted Diagnostics in CHD Screening
China19,697 participantsStarted 2025-09-22
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria (Schools):
* The school is of the type: kindergarten, primary school, junior high school, or senior high school.
* The school has medical screening facilities and conditions that can support AI-assisted screening.
* The area where the school is located has at least one primary healthcare institution willing to participate in this trial.
* The school's management and teaching staff are willing to participate in the study and can cooperate to complete the related screening and data collection work.
Exclusion Criteria (Schools):
* More than half of the students in the school refuse to participate in the trial.
* Schools that are unable to complete the study due to severe limitations in geographical location and transportation conditions.
* Schools lacking medical screening facilities and conditions necessary for the implementation of screening.
* Areas where there are no primary healthcare institutions willing to participate in this trial.
* Schools whose management and teaching staff refuse to participate in the study or are unable to cooperate in completing the related screening and data collection work.
Inclusion Criteria (Individuals):
* Children aged between 0 and 18 years, regardless of gender.
* Children who agree to undergo echocardiography to determine the presence of congenital heart disease.
* Individuals who voluntarily participate in this study and sign the informed consent form.
Exclusion Criteria (Individuals):
* Individuals over the age …
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Sensitivity of auscultation in identifying CHD between independent auscultation by primary care physicians and AI-assisted auscultation by primary care physicians
Timeframe: From enrollment to the end of treatment at 6 months