AsthmaNCT07383883
Multimodal Tongue-Pulse Information Fusion for Syndrome Diagnosis and Cohort Study in Children With Asthma
An observational study of Asthma, run by Shanghai Children's Medical Center at 1 site in China.
Trial summary
Asthma is one of the most prevalent chronic respiratory diseases in children, and accurate phenotyping and disease monitoring remain challenging in routine clinical practice. This observational cohort study aims to investigate the clinical value of multimodal tongue and pulse information in the syndrome diagnosis and… Read more about this study
- Who is it for?
- Ages 5 to 18 years
- Conditions the study is for
- Asthma
- How many people
- 1,000 participants
- Where
- 1 siteChina
- Study dates
- 1 Feb 2026to 31 Jan 2028
- 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 5 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: The study population consists of children aged 5 to 18 years with a confirmed diagnosis of asthma who are undergoing routine outpatient follow-up at Shanghai Children's Medical Center. Participants are enrolled prospectively and receive standard clinical care without any study-assigned intervention. Tongue image and pulse wave data are collected non-invasively during visits when pulmonary function testing is performed as part of routine clinical practice. Multimodal tongue-pulse features are analyzed in relation to asthma clinical stage, pulmonary function, airway inflammation, allergic phenotype, and asthma control status.
Who may be able to join
- Children aged 5 to 18 years.
- Clinically diagnosed asthma according to established pediatric asthma guidelines.
- Receiving routine outpatient follow-up at Shanghai Children's Medical Center.
- Able to cooperate with tongue image acquisition and pulse wave data collection.
- Able to perform pulmonary function testing when clinically indicated.
- Written informed consent obtained from parents or legal guardians, with assent from the child when appropriate.
Who cannot join
- Presence of other chronic respiratory diseases (e.g., cystic fibrosis, bronchiectasis, primary ciliary dyskinesia).
- Congenital cardiopulmonary malformations or significant cardiovascular disease.
- Acute respiratory infection or fever at the time of data collection.
- Severe systemic diseases or immunodeficiency that may affect study participation.
- Inability to comply with study procedures or incomplete clinical data.
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, 1 recruiting
- Recruiting
Shanghai Children's Medical Center
Shanghai, 200127
Yong Yin, PhD, 8618930830705, yinyong9999@163.com
About this study
Asthma is one of the most prevalent chronic respiratory diseases in children, and accurate phenotyping and disease monitoring remain challenging in routine clinical practice. This observational cohort study aims to investigate the clinical value of multimodal tongue and pulse information in the syndrome diagnosis and phenotypic characterization of pediatric asthma. Children aged 5-18 years with a confirmed diagnosis of asthma will be enrolled at Shanghai Children's Medical Center and followed in routine outpatient care.
Standardized tongue images and pulse wave data will be collected using validated acquisition devices during visits when lung function testing is performed. Quantitative features extracted from tongue and pulse data will be integrated with clinical information, including asthma stage, lung function parameters, eosinophil counts, allergic sensitization status, and Asthma Control Questionnaire-5 (ACQ-5) scores. The primary objective is to evaluate the associations between tongue-pulse multimodal features and asthma clinical stages and pulmonary function. Secondary objectives include exploring their relationships with airway inflammation and asthma control status.
This study seeks to establish a non-invasive, objective, and quantifiable approach to asthma phenotyping, providing evidence for integrating traditional diagnostic features with modern clinical data to support precision management of pediatric asthma.
Read the detailed description
This study is a single-center, observational cohort study designed to investigate the clinical value of multimodal tongue and pulse characteristics in the phenotypic classification and disease monitoring of pediatric asthma. The study will be conducted at Shanghai Children's Medical Center and will enroll children aged 5-18 years with a confirmed diagnosis of asthma who are undergoing routine outpatient follow-up.
Standardized tongue images and pulse wave data will be collected using validated tongue diagnosis and pulse diagnosis devices during outpatient visits in which pulmonary function testing is clinically indicated. Tongue image acquisition will be performed under controlled lighting and positioning conditions to ensure reproducibility, while pulse wave signals will be recorded using standardized sensor placement and acquisition protocols. These procedures are non-invasive and are integrated into routine clinical workflows without altering standard medical care.
Quantitative features will be extracted from tongue images and pulse waveforms using image processing and signal analysis methods, including color space transformation, texture analysis, brightness distribution, and pulse waveform time-domain and frequency-domain parameters. These multimodal features will be systematically linked to clinical data, including asthma clinical stage (acute exacerbation, chronic persistent phase, or clinical remission), pulmonary function parameters, such as Forced Expiratory Volume in 1 second(FEV₁), Forced Expiratory Volume in 1 second/Forced Vital Capacity(FEV₁/FVC), Resistance at 5 Hz(R5), and Resistance at 20 Hz(R20), fractional exhaled nitric oxide when available, blood eosinophil counts, allergic sensitization status, and Asthma Control Questionnaire-5 (ACQ-5) scores.
The primary objective of the study is to evaluate the associations between multimodal tongue-pulse quantitative features and asthma clinical stages and pulmonary function status. Secondary objectives include exploring the relationships between tongue-pulse features and airway inflammation, asthma control level, and allergic phenotype, as well as assessing their potential utility in phenotypic stratification and longitudinal disease monitoring.
Participants will be followed according to routine clinical practice, with repeated data collection occurring only when pulmonary function testing is performed as part of standard care. Longitudinal analyses will be conducted using time-stamped clinical and tongue-pulse data to account for irregular visit intervals. This study aims to establish a non-invasive, objective, and quantifiable framework for integrating traditional diagnostic features with modern clinical indicators, providing evidence to support precision phenotyping and individualized management of pediatric asthma.
- Conditions
- Asthma
- Being tested
- No intervention (observational study)
- Keywords
- asthma, Tongue-Pulse Diagnosis, Multimodal Phenotyping
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No intervention (observational study)Other
No intervention (observational study)
| Study group | Role | What they receive |
|---|---|---|
| Pediatric Asthma Cohort | Children aged 5 to 18 years with a confirmed diagnosis of asthma receiving routine outpatient follow-up at Shanghai Children's Medical Center. Participants undergo non-invasive tongue image and pulse wave data collection during visits when pulmonary function testing is clinically indicated. No intervention is assigned. All clinical management follows standard care. Tongue-pulse multimodal features are analyzed in relation to asthma clinical stage, pulmonary function, airway inflammation, allergic phenotype, and asthma control status. Receives: Other: No intervention (observational study) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Association Between Tongue-Pulse Multimodal Features and Pulmonary Function in Pediatric Asthma
The primary outcome is the correlation between quantitative tongue-pulse multimodal features and pulmonary function parameters in children with asthma. Tongue images and pulse wave signals are collected during routine outpatient visits and analyzed to extract quantitative features, such as color, texture, and shape parameters of the tongue images, as well as pulse rate and amplitude from the pulse wave signals. Pulmonary function parameters, including FEV₁ (Forced Expiratory Volume in 1 second, measured in liters), FEV₁/FVC (Forced Expiratory Volume in 1 second to Forced Vital Capacity ratio, measured as a percentage), and airway resistance indices (R5 and R20, measured in cm H₂O/L/s), are obtained as part of standard clinical care. Correlation and regression analyses will be performed to evaluate the correlation between tongue-pulse features and pulmonary function status. Time Frame: During routine outpatient visits at baseline and follow-up when pulmonary function testing is perform
Measured: During routine outpatient visits at baseline and follow-up when pulmonary function testing is performed (up to 12 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2026
- Study start1 Feb 2026
- Primary completion31 Jan 2028 (estimated)
- Study completion31 Jan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AsthmaStudies 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
- 1,000 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
- NCT07383883
- Sponsor's protocol ID
- SCMCIRB-YJ2025013
- Status last verified
- Mar 2026
- First submitted
- 14 Dec 2025
- Last updated
- 10 Mar 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 10 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multimodal Tongue-Pulse Information Fusion for Syndrome Diagnosis and Cohort Study in Children With Asthma
- ClinicalTrials.gov ID
- NCT07383883
- Acronym / sponsor ID
- SCMCIRB-YJ2025013
- Conditions
- Asthma
- Keywords
- asthma, Tongue-Pulse Diagnosis, Multimodal Phenotyping
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Shanghai Children's Medical CenterUniversity, hospital or other
- Study start
- 1 Feb 2026 (actual)
- Primary completion
- 31 Jan 2028 (estimated)
- Study completion
- 31 Jan 2028 (estimated)
- First posted
- 3 Feb 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.
Asthma is one of the most prevalent chronic respiratory diseases in children, and accurate phenotyping and disease monitoring remain challenging in routine clinical practice. This observational cohort study aims to investigate the clinical value of multimodal tongue and pulse information in the syndrome diagnosis and phenotypic characterization of pediatric asthma. Children aged 5-18 years with a confirmed diagnosis of asthma will be enrolled at Shanghai Children's Medical Center and followed in routine outpatient care.
Standardized tongue images and pulse wave data will be collected using validated acquisition devices during visits when lung function testing is performed. Quantitative features extracted from tongue and pulse data will be integrated with clinical information, including asthma stage, lung function parameters, eosinophil counts, allergic sensitization status, and Asthma Control Questionnaire-5 (ACQ-5) scores. The primary objective is to evaluate the associations between tongue-pulse multimodal features and asthma clinical stages and pulmonary function. Secondary objectives include exploring their relationships with airway inflammation and asthma control status.
This study seeks to establish a non-invasive, objective, and quantifiable approach to asthma phenotyping, providing evidence for integrating traditional diagnostic features with modern clinical data to support precision management of pediatric asthma.
Detailed description
This study is a single-center, observational cohort study designed to investigate the clinical value of multimodal tongue and pulse characteristics in the phenotypic classification and disease monitoring of pediatric asthma. The study will be conducted at Shanghai Children's Medical Center and will enroll children aged 5-18 years with a confirmed diagnosis of asthma who are undergoing routine outpatient follow-up.
Standardized tongue images and pulse wave data will be collected using validated tongue diagnosis and pulse diagnosis devices during outpatient visits in which pulmonary function testing is clinically indicated. Tongue image acquisition will be performed under controlled lighting and positioning conditions to ensure reproducibility, while pulse wave signals will be recorded using standardized sensor placement and acquisition protocols. These procedures are non-invasive and are integrated into routine clinical workflows without altering standard medical care.
Quantitative features will be extracted from tongue images and pulse waveforms using image processing and signal analysis methods, including color space transformation, texture analysis, brightness distribution, and pulse waveform time-domain and frequency-domain parameters. These multimodal features will be systematically linked to clinical data, including asthma clinical stage (acute exacerbation, chronic persistent phase, or clinical remission), pulmonary function parameters, such as Forced Expiratory Volume in 1 second(FEV₁), Forced Expiratory Volume in 1 second/Forced Vital Capacity(FEV₁/FVC), Resistance at 5 Hz(R5), and Resistance at 20 Hz(R20), fractional exhaled nitric oxide when available, blood eosinophil counts, allergic sensitization status, and Asthma Control Questionnaire-5 (ACQ-5) scores.
The primary objective of the study is to evaluate the associations between multimodal tongue-pulse quantitative features and asthma clinical stages and pulmonary function status. Secondary objectives include exploring the relationships between tongue-pulse features and airway inflammation, asthma control level, and allergic phenotype, as well as assessing their potential utility in phenotypic stratification and longitudinal disease monitoring.
Participants will be followed according to routine clinical practice, with repeated data collection occurring only when pulmonary function testing is performed as part of standard care. Longitudinal analyses will be conducted using time-stamped clinical and tongue-pulse data to account for irregular visit intervals. This study aims to establish a non-invasive, objective, and quantifiable framework for integrating traditional diagnostic features with modern clinical indicators, providing evidence to support precision phenotyping and individualized management of pediatric asthma.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pediatric Asthma Cohort | – | Other: No intervention (observational study)Children aged 5 to 18 years with a confirmed diagnosis of asthma receiving routine outpatient follow-up at Shanghai Children's Medical Center. Participants undergo non-invasive tongue image and pulse wave data collection during visits when pulmonary function testing is clinically indicated. No intervention is assigned. All clinical management follows standard care. Tongue-pulse multimodal features are analyzed in relation to asthma clinical stage, pulmonary function, airway inflammation, allergic phenotype, and asthma control status. |
Who may qualify
- Ages
- 5 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- The study population consists of children aged 5 to 18 years with a confirmed diagnosis of asthma who are undergoing routine outpatient follow-up at Shanghai Children's Medical Center. Participants are enrolled prospectively and receive standard clinical care without any study-assigned intervention. Tongue image and pulse wave data are collected non-invasively during visits when pulmonary function testing is performed as part of routine clinical practice. Multimodal tongue-pulse features are analyzed in relation to asthma clinical stage, pulmonary function, airway inflammation, allergic phenotype, and asthma control status.
Key inclusion criteria (6 listed)
- Children aged 5 to 18 years.
- Clinically diagnosed asthma according to established pediatric asthma guidelines.
- Receiving routine outpatient follow-up at Shanghai Children's Medical Center.
- Able to cooperate with tongue image acquisition and pulse wave data collection.
- Able to perform pulmonary function testing when clinically indicated.
Key exclusion criteria (5 listed)
- Presence of other chronic respiratory diseases (e.g., cystic fibrosis, bronchiectasis, primary ciliary dyskinesia).
- Congenital cardiopulmonary malformations or significant cardiovascular disease.
- Acute respiratory infection or fever at the time of data collection.
- Severe systemic diseases or immunodeficiency that may affect study participation.
- Inability to comply with study procedures or incomplete clinical data.
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 |
|---|---|---|
| No intervention (observational study)No intervention (observational study) | Other | Pediatric Asthma Cohort |
Primary outcome
Association Between Tongue-Pulse Multimodal Features and Pulmonary Function in Pediatric Asthma
Time frame: During routine outpatient visits at baseline and follow-up when pulmonary function testing is performed (up to 12 months)
The primary outcome is the correlation between quantitative tongue-pulse multimodal features and pulmonary function parameters in children with asthma. Tongue images and pulse wave signals are collected during routine outpatient visits and analyzed to extract quantitative features, such as color, texture, and shape parameters of the tongue images, as well as pulse rate and amplitude from the pulse wave signals. Pulmonary function parameters, including FEV₁ (Forced Expiratory Volume in 1 second, measured in liters), FEV₁/FVC (Forced Expiratory Volume in 1 second to Forced Vital Capacity ratio, measured as a percentage), and airway resistance indices (R5 and R20, measured in cm H₂O/L/s), are obtained as part of standard clinical care. Correlation and regression analyses will be performed to evaluate the correlation between tongue-pulse features and pulmonary function status. Time Frame: During routine outpatient visits at baseline and follow-up when pulmonary function testing is perform
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 10 Mar 2026.
Related trials for Asthma
RecruitingPhase 1
Pilot Study to Identify the Mediators and Inflammatory Cell Surface Receptors Involved in Allergic Airway Inflammation
Asthma
RecruitingPhase 1
A Study to Compare the Relative Potency of Salbutamol Administered Via Metered Dose Inhalers (MDI) Containing Propellants HFA-152a to HFA-134a in Mild Asthmatics Aged 18 to 65 Inclusive
Asthma, Mild Asthma
RecruitingPhase 3
A Study Assessing the Effect of Dupilumab on Inducing Clinical Remission in Asthma
Asthma Control
Active, not recruitingPhase 2/3
Local Antibiotic Delivery for Community Acquired Pneumonia
Community Acquired Pneumonia (CAP)
RecruitingPhase 2
A Study to Learn About the Study Medicine Called PF-07275315 in People With Moderate-To-Severe Asthma
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, 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 6 inclusion and 5 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: looking for participants now, as of the sponsor's last update on 10 Mar 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 (86-021-38626161 ext. 83015, yinyong9999@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Association Between Tongue-Pulse Multimodal Features and Pulmonary Function in Pediatric Asthma (time frame: During routine outpatient visits at baseline and follow-up when pulmonary function testing is performed (up to 12 months)). 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 10 Mar 2026.