Asthma (Diagnosis)NCT07613242
Multimodal Assisted Diagnosis for Pediatric Respiratory Diseases Using Questionnaires, Cough Sounds, and Breath Sounds
An observational study of Asthma (Diagnosis) and Community-Acquired Pneumonia (CAP), run by Shanghai Children's Medical Center at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 28 days to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Asthma (Diagnosis), Community-Acquired Pneumonia (CAP)
- What is being tested?
- Multimodal respiratory data collection
- How many people
- 1,400 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2026to 31 May 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 28 days to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Shanghai Children's Medical Center
Shanghai, Shanghai Municipality, 200127
Yong Yin, +83015 86-021-38626161, yinyong9999@163.com
About this study
Official title: 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.
Read the 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.
- Being tested
- Multimodal respiratory data collection
- Medical subject headings
- Asthma, Disease, Community-Acquired Pneumonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multimodal respiratory data collectionDiagnostic 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Diagnostic Test: Multimodal respiratory data collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Through study completion, an average of 1 year
Secondary outcomes (6)
Sensitivity of the multimodal assisted diagnostic model
Measured: Through study completion, an average of 1 year
Specificity of the multimodal assisted diagnostic model
Measured: Through study completion, an average of 1 year
Positive predictive value of the multimodal assisted diagnostic model
Measured: Through study completion, an average of 1 year
Negative predictive value of the multimodal assisted diagnostic model
Measured: Through study completion, an average of 1 year
F1 score of the multimodal assisted diagnostic model
Measured: Through study completion, an average of 1 year
Accuracy of the multimodal assisted diagnostic model
Measured: Through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2026
- Study start1 Jun 2026 (estimated)
- Primary completion1 May 2029 (estimated)
- Study completion31 May 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Asthma (Diagnosis)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Children's Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yong Yin, Principal investigator, Shanghai Children's Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07613242
- Sponsor's protocol ID
- SCMCIRB-YJ20260516
- Status last verified
- May 2026
- First submitted
- 16 May 2026
- Last updated
- 29 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Observational Study of Multimodal Assisted Diagnosis for Pediatric Respiratory Diseases Using Symptom Questionnaires, Cough Sounds, and Breath Sounds
- ClinicalTrials.gov ID
- NCT07613242
- Acronym / sponsor ID
- SCMCIRB-YJ20260516
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 1,400 participants (estimated)
- Lead sponsor
- Shanghai Children's Medical CenterUniversity, hospital or other
- Study start
- 1 Jun 2026 (estimated)
- Primary completion
- 1 May 2029 (estimated)
- Study completion
- 31 May 2029 (estimated)
- First posted
- 29 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Children with respiratory complaints | – | Diagnostic Test: Multimodal respiratory data collectionChildren aged 28 days to 18 years presenting with cough, wheezing, fever with respiratory symptoms, nasal congestion, rhinorrhea, sore throat, or other respiratory complaints. |
| Healthy controls | – | Diagnostic Test: Multimodal respiratory data collectionChildren 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. |
Who may qualify
- Ages
- 28 days to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- 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.
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Multimodal respiratory data collectionParticipants 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. | Diagnostic test | Children with respiratory complaints, Healthy controls |
Primary outcome
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.
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.
6 secondary outcomes
Sensitivity of the multimodal assisted diagnostic model
Time frame: 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
Positive predictive value of the multimodal assisted diagnostic model
Time frame: 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
F1 score of the multimodal assisted diagnostic model
Time frame: 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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2026.
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Asthma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Yong Yin principal investigator
Shanghai Children's Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Asthma (Diagnosis) and Community-Acquired Pneumonia (CAP), run by Shanghai Children's Medical Center at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 29 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yong Yin (+83015 86-021-38626161, yinyong9999@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Area under the receiver operating characteristic curve of the multimodal assisted diagnostic model (time frame: Through study completion, an average of 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 May 2026.