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

NCT07613242 · tracked via the Priya Life Science China tracker

Sponsor

Shanghai Children's Medical Center

Phase

Observational

Started

2026-06-01

Last updated

2026-05-29

Condition(s) studied

Asthma (Diagnosis)Community-Acquired Pneumonia (CAP)

Investigational drug(s) / intervention(s)

Multimodal respiratory data collection

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.

Study summary

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.

Eligibility

Sex

ALL

Min age

28 Days

Max age

18 Years

Healthy volunteers

Accepted

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.

Primary outcome measure(s)

Area under the receiver operating characteristic curve of the multimodal assisted diagnostic model — 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.
Area under the precision-recall curve of the multimodal assisted diagnostic model — 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.

Trial sites (1)

Facility	City	Region	Status
Shanghai Children's Medical Center	Shanghai	Shanghai Municipality

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07613242 on ClinicalTrials.gov ↗ ← All trials in China