Not Yet RecruitingNot Applicable

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

China1,400 participantsStarted 2026-06-01

Plain-language 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.

Who can participate

Age range

28 Days – 18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 suita…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1This trial uses questionnaires, cough sounds, and breath sounds to help diagnose asthma or pneumonia in children — how does this kind of AI-assisted diagnostic approach compare to the standard tools your practice already uses to make those diagnoses?
2Since this study hasn't started recruiting yet, do you know when it's expected to open, and would it make sense for us to wait for it or pursue a diagnosis through conventional methods now given my child's current symptoms?
3The trial is measuring how accurately this multimodal model can distinguish between asthma and community-acquired pneumonia — if we were to participate, what would the diagnostic process actually look like for my child, and would it replace or just supplement your normal evaluation?
4Because this is a diagnostic study rather than a treatment trial, what happens after the model gives a result — would my child still receive the same care decisions based on your clinical judgment, or could the model's output directly affect their treatment path?
5Are there any risks or burdens involved in participating, such as extra clinic visits or delays in getting a confirmed diagnosis, that we should weigh against any potential benefit of being part of this research?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

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

Timeframe: Through study completion, an average of 1 year

Area under the precision-recall curve of the multimodal assisted diagnostic model

Timeframe: Through study completion, an average of 1 year

Trial details

NCT IDNCT07613242

SponsorShanghai Children's Medical Center

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2029-05-01

Contact for this trial

Yong Yin

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

View on ClinicalTrials.gov More Asthma (Diagnosis) trials