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NCT Number: NCT06542120

Research on Body Voice AI Recognition System for Children's Health Management

The purpose of this research is to develop a body voice artificial intelligence (AI) recognition device, also referred to as an AI-assisted body sound identification device, by utilizing a deep learning-based novel AI algorithm in conjunction with a big body voice model. It could identify normal and abnormal heart, breath, and bowel sounds, and to provide early screening and auxiliary diagnosis of congenital heart disease (CHD), respiratory infections, diarrhea and other common multi-occurring diseases.

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Key information

Age range

Up to 18 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Wuhan Children's Hospital (Wuhan Maternal and Child Healthcare Hospital), Tongji Medical College, Huazhong University of Science and Technology, Wuhan, Hubei, China

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About this study

The study employed a multicenter cross-sectional design. The real-world data collected for this study included normal and definitively diagnosed heart sounds in children with congenital heart disease, normal and definitively diagnosed respiratory tract infections in children with breath sounds, specific cough sounds, and normal and definitively diagnosed children's bowel sounds with diarrhea. The specialist team will carry out data governance, annotation, and feature sound extraction on the gathered normal and aberrant sounds, in order to generate a superior multimodal training dataset. Large model artificial intelligence algorithms (deep learning, machine learning, etc.) are used to model and train the algorithm model of the body voice AI recognition device, so that it can distinguish between normal and abnormal sound signals by AI. The results of body sound AI identification will be compared with diagnostic reports from echocardiograms, chest X-rays, and belly X-rays in terms of AUC (Area Under Curve) score, sensitivity, specificity, and accuracy to evaluate the impact of AI recognition devices on illness screening and supplementary diagnosis. External validation will be conducted using homogeneous data from other sites. This project aims to develop a new generation of intelligent sound auscultation instruments that could be used for early screening and auxiliary diagnosis of congenital heart disease , respiratory infections, diarrhea and other common multi-occurring diseases by utilizing large model artificial intelligence technologies.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age 0~18 years old, gender is not limited
  • Children who have been diagnosed with congenital heart disease by cardiac ultrasound or who do not have congenital heart disease
  • Children diagnosed with bronchopneumonia or without bronchopneumonia
  • Children who are clinically diagnosed with intestinal diseases or who do not suffer from intestinal diseases
  • Informed consent

Exclusion criteria

  • ≥ 18 years old
  • Children who are unable to undergo cardiac ultrasound, chest imaging or other related examinations
  • Subjects who are unable to obtain informed consent, or who are unwilling to cooperate with the provision of diagnosis and treatment related data for further analysis and research as required by the study.

Treatment and study plan

Heart Auscultation and Echocardiography

Diagnostic Test

Heart auscultation will be done by pediatrician and echocardiography by echocardiologist

Chest Auscultation and Chest imaging examinations

Diagnostic Test

Chest auscultation will be done by pediatrician and chest imaging examinations by radiologist

Abdominal Auscultation and Abdominal imaging examinations

Diagnostic Test

Abdominal auscultation will be done by pediatrician and chest imaging examinations by radiologist

Primary outcomes

  1. Sensitivity

    Time frame: 1 month

    Sensitivity in CHD, lung disease and abdominal screening by different artificial intelligence algorithm and auscultation

  2. Specificity

    Time frame: 1 month

    Specificity in CHD, lung disease and abdominal screening by different artificial intelligence algorithm and auscultation

  3. AUC

    Time frame: 1 month

    AUC in CHD, lung disease and abdominal screening by different artificial intelligence algorithm and auscultation

Study contacts

Contact information is provided by the study sponsor or research team.

Sponsors and collaborators

Lead sponsor

Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

Other

Registry information

Official study title

Intelligent Voice Model: A New Paradigm Exploration for Child Health Management

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Aug 7, 2024
Registry last updated
Aug 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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