Multimodal Assisted Diagnosis for Pediatric Respiratory Diseases Using Questionnaires, Cough Sounds, and Breath Sounds

May 23, 2026 updated by: Shanghai Children's Medical Center

A Prospective Observational Study of Multimodal Assisted Diagnosis for Pediatric Respiratory Diseases Using Symptom Questionnaires, Cough Sounds, and Breath Sounds

This study aims to establish a standardized, synchronized data collection system for pediatric symptom questionnaires, cough sounds, and breath sounds, and to construct a multimodal database of pediatric respiratory diseases including both disease cases and healthy controls. Using the final research labels determined by clinicians' diagnoses, health status assessments, and research team review as the reference standard, this study will develop and validate a multimodal assisted diagnostic model for common pediatric respiratory diseases based on symptom questionnaires, cough sounds, and breath sounds. The study will primarily evaluate the diagnostic performance of the model in distinguishing healthy children from children with respiratory diseases, screening for asthma and asthma-related cough, and identifying pneumonia, tracheitis/bronchitis, upper airway-related diseases, and common causes of chronic cough. It will also assess the incremental value of cough sounds and breath sounds beyond symptom questionnaire information.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

This is a prospective, observational diagnostic accuracy study to be conducted at Shanghai Children's Medical Center. The study population will include children presenting with cough, wheezing, fever with respiratory symptoms, nasal congestion, rhinorrhea, sore throat, or other respiratory complaints, as well as healthy children recruited during routine health examinations. The study will establish a standardized and synchronized data collection workflow for pediatric symptom questionnaires, cough sounds, and breath sounds. All enrolled participants will complete a structured symptom questionnaire, undergo cough sound recording using a smartphone application, and undergo breath sound recording using an electronic stethoscope under unified protocols. Demographic and clinical information, including age, sex, disease duration, major symptoms, medical history, allergy history, family history, medication use, final clinical diagnosis, or health status assessment, will also be collected to construct a multimodal database of pediatric respiratory diseases including both disease cases and healthy controls. Based on this database, the study will develop a stepwise multimodal assisted diagnostic framework using a combination of conventional statistical learning and deep learning methods. Three diagnostic models will be constructed and compared: a symptom questionnaire-only model, a symptom questionnaire plus cough sound model, and a multimodal model integrating symptom questionnaires, cough sounds, and breath sounds. Using the final research labels determined by clinicians' diagnoses, health status assessments, and research team review as the reference standard, the study will evaluate the diagnostic performance of these models in distinguishing healthy children from children with respiratory diseases, screening for asthma and asthma-related cough, and identifying pneumonia, tracheitis/bronchitis, upper airway-related diseases, and common causes of chronic cough. Model performance will be assessed using AUC, AUPRC, sensitivity, specificity, positive predictive value, negative predictive value, F1 score, and accuracy. The study will further investigate the incremental value of cough sounds and breath sounds beyond symptom questionnaire information, and assess model stability and generalizability across different age groups, clinical settings, and device conditions. The findings are expected to provide evidence for the optimization, clinical translation, and potential home-based extension of multimodal artificial intelligence-assisted diagnostic models for pediatric respiratory diseases. The study will not interfere with routine clinical care, and the model outputs will not be used for real-time clinical decision-making.

Study Type

Observational

Enrollment (Estimated)

1400

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Shanghai Municipality
      • Shanghai, Shanghai Municipality, China, 200127
        • Shanghai Children's Medical Center
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

The target population will include children aged 28 days to 18 years, including children presenting to the outpatient department, emergency department, or inpatient wards of Shanghai Children's Medical Center with cough, wheezing, fever with respiratory symptoms, nasal congestion, rhinorrhea, sore throat, or other respiratory complaints, as well as healthy children recruited during routine health examinations or children without respiratory complaints. The study population will cover common pediatric respiratory diseases and healthy controls, providing a representative disease spectrum.

Description

Inclusion Criteria:

Children aged 28 days to 18 years, regardless of sex, will be eligible for inclusion. The disease group will include children presenting to the outpatient department, emergency department, or inpatient wards of Shanghai Children's Medical Center with cough, wheezing, fever with respiratory symptoms, nasal congestion, rhinorrhea, sore throat, or other respiratory complaints. Participants should be able to complete the symptom questionnaire, cough sound recording, and breath sound recording, and their guardians must provide informed consent and allow review of relevant medical history and diagnostic information. The healthy control group will include children recruited from routine health examinations or children without respiratory complaints, with no acute respiratory symptoms within the past 4 weeks, no known history of chronic respiratory diseases, no obvious respiratory abnormalities on health assessment or research team review, the ability to complete relevant data collection, and guardian informed consent.

Exclusion Criteria:

Participants will be excluded if they have severe cardiopulmonary malformations, long-term tracheostomy or mechanical ventilation, severe neuromuscular disorders, severe immunodeficiency, or other conditions that may substantially alter cough sound characteristics or affect the clinical presentation of respiratory diseases. Children whose primary diagnosis at the current visit is a non-respiratory disease and who are not suitable for this study will also be excluded. Participants who are unable to complete the symptom questionnaire, or whose cough sound or breath sound recordings remain of insufficient quality after repeated attempts, will not be included or will be excluded from the corresponding modality-specific analysis. Participants with only one unavailable modality may be included in analyses based on the completed modalities but will be excluded from analyses requiring the missing modality. Healthy controls will be excluded from the main control analysis if recent respiratory symptoms, a history of chronic respiratory disease, or other conditions that may affect acoustic features are identified.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Children with respiratory complaints
Children aged 28 days to 18 years presenting with cough, wheezing, fever with respiratory symptoms, nasal congestion, rhinorrhea, sore throat, or other respiratory complaints.
Diagnostic test: Multimodal respiratory data collection
Participants will complete a structured symptom questionnaire, cough sound recording using a smartphone application, and breath sound recording using an electronic stethoscope. These data will be used to develop and evaluate a multimodal assisted diagnostic model and will not guide real-time clinical decision-making.
Healthy controls
Children aged 28 days to 18 years recruited from routine health examinations or without respiratory complaints, with no acute respiratory symptoms within the past 4 weeks and no known chronic respiratory disease.
Diagnostic test: Multimodal respiratory data collection
Participants will complete a structured symptom questionnaire, cough sound recording using a smartphone application, and breath sound recording using an electronic stethoscope. These data will be used to develop and evaluate a multimodal assisted diagnostic model and will not guide real-time clinical decision-making.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Area under the receiver operating characteristic curve of the multimodal assisted diagnostic model
Time Frame: Through study completion, an average of 1 year
The area under the receiver operating characteristic curve will be used to evaluate the diagnostic performance of the multimodal assisted diagnostic model integrating symptom questionnaire, cough sound, and breath sound data. The model will be assessed against the final clinical research label for distinguishing children with respiratory diseases from healthy controls and for identifying major pediatric respiratory disease categories.
Through study completion, an average of 1 year
Area under the precision-recall curve of the multimodal assisted diagnostic model
Time Frame: Through study completion, an average of 1 year
The area under the precision-recall curve will be used to evaluate the diagnostic performance of the multimodal assisted diagnostic model, particularly in settings with imbalanced disease categories. The model will be assessed against the final clinical research label.
Through study completion, an average of 1 year

Secondary Outcome Measures

Outcome Measure
Time Frame
Sensitivity of the multimodal assisted diagnostic model
Time Frame: Through study completion, an average of 1 year
Through study completion, an average of 1 year
Specificity of the multimodal assisted diagnostic model
Time Frame: Through study completion, an average of 1 year
Through study completion, an average of 1 year
Positive predictive value of the multimodal assisted diagnostic model
Time Frame: Through study completion, an average of 1 year
Through study completion, an average of 1 year
Negative predictive value of the multimodal assisted diagnostic model
Time Frame: Through study completion, an average of 1 year
Through study completion, an average of 1 year
F1 score of the multimodal assisted diagnostic model
Time Frame: Through study completion, an average of 1 year
Through study completion, an average of 1 year
Accuracy of the multimodal assisted diagnostic model
Time Frame: Through study completion, an average of 1 year
Through study completion, an average of 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shanghai Children's Medical Center

Investigators

  • Principal Investigator: Yong Yin, Shanghai Children's Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

June 1, 2026

Primary Completion (Estimated)

May 1, 2029

Study Completion (Estimated)

May 31, 2029

Study Registration Dates

First Submitted

May 16, 2026

First Submitted That Met QC Criteria

May 23, 2026

First Posted (Actual)

May 29, 2026

Study Record Updates

Last Update Posted (Actual)

May 29, 2026

Last Update Submitted That Met QC Criteria

May 23, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SCMCIRB-YJ20260516

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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