跳至主要内容
临床试验/NCT06542120
NCT06542120招募中不适用

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

Xinhua Hospital, Shanghai Jiao Tong University School of Medicine10 个研究点 分布在 1 个国家目标入组 30,000 人开始时间: 2024年5月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
30,000
试验地点
10
主要终点
Specificity

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Cross Sectional

入排标准

年龄范围
— 至 18 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • ≥ 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.

研究组 & 干预措施

0 ~ 18 years old children

Age range: 0 to 18 years old, with no gender restriction. Children who have been diagnosed with congenital heart disease (CHD) or confirmed to be free of CHD through echocardiographic examinations.

Children who have been diagnosed with bronchopneumonia or confirmed to be free of bronchopneumonia through chest imaging examinations.

Children who have been diagnosed with abdominal diseases or confirmed to be free of abdominal diseases through abdominal imaging examinations.

干预措施: Heart Auscultation and Echocardiography (Diagnostic Test)

0 ~ 18 years old children

Age range: 0 to 18 years old, with no gender restriction. Children who have been diagnosed with congenital heart disease (CHD) or confirmed to be free of CHD through echocardiographic examinations.

Children who have been diagnosed with bronchopneumonia or confirmed to be free of bronchopneumonia through chest imaging examinations.

Children who have been diagnosed with abdominal diseases or confirmed to be free of abdominal diseases through abdominal imaging examinations.

干预措施: Chest Auscultation and Chest imaging examinations (Diagnostic Test)

0 ~ 18 years old children

Age range: 0 to 18 years old, with no gender restriction. Children who have been diagnosed with congenital heart disease (CHD) or confirmed to be free of CHD through echocardiographic examinations.

Children who have been diagnosed with bronchopneumonia or confirmed to be free of bronchopneumonia through chest imaging examinations.

Children who have been diagnosed with abdominal diseases or confirmed to be free of abdominal diseases through abdominal imaging examinations.

干预措施: Abdominal Auscultation and Abdominal imaging examinations (Diagnostic Test)

结局指标

主要结局

Specificity

时间窗: 1 month

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

Sensitivity

时间窗: 1 month

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

AUC

时间窗: 1 month

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

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (10)

Loading locations...

相似试验