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

NCT07613242 | Not Yet Recruiting DMC

• 1 other identifier: SCMCIRB-YJ20260516
• Study Type: observational
• Target: 1,400
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Asthma (Diagnosis); Community-Acquired Pneumonia (CAP)

Outcome Measures

Primary Outcomes (2)

• Area under the receiver operating characteristic curve of the multimodal assisted diagnostic model

  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

  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 Outcomes (6)

• Sensitivity of the multimodal assisted diagnostic model

  Through study completion, an average of 1 year

• Specificity of the multimodal assisted diagnostic model

  Through study completion, an average of 1 year

• Positive predictive value of the multimodal assisted diagnostic model

  Through study completion, an average of 1 year

• Negative predictive value of the multimodal assisted diagnostic model

  Through study completion, an average of 1 year

• F1 score of the multimodal assisted diagnostic model

  Through study completion, an average of 1 year

Study Arms (2)

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

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

Interventions

Multimodal respiratory data collection DIAGNOSTIC_TEST

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.

Children with respiratory complaints; Healthy controls

Eligibility Criteria

• Age: 28 Days - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shanghai Children's Medical Center: lead

Study Sites (1)

Shanghai Children's Medical Center

Shanghai, Shanghai Municipality, 200127, China

Location

MeSH Terms

Conditions

Asthma; Disease; Community-Acquired Pneumonia

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Community-Acquired Infections; Infections; Pneumonia; Respiratory Tract Infections

Study Officials

• Yong Yin

  Shanghai Children's Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yong Yin

CONTACT

+83015 86-021-38626161; yinyong9999@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 16, 2026
• First Posted: May 29, 2026
• Study Start: June 1, 2026
• Primary Completion (Estimated): May 1, 2029
• Study Completion (Estimated): May 31, 2029
• Last Updated: May 29, 2026

Record last verified: 2026-05

Locations

CN (1)