Multimodal Tongue-Pulse Information Fusion for Syndrome Diagnosis and Cohort Study in Children With Asthma

March 6, 2026 updated by: Shanghai Children's Medical Center

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Estimated)

1000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
      • Shanghai, China, 200127
        • Recruiting
        • Shanghai Children's Medical Center
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

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.

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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.
Other: No intervention (observational study)
No intervention (observational study)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
During routine outpatient visits at baseline and follow-up when pulmonary function testing is performed (up to 12 months)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shanghai Children's Medical Center

Investigators

  • Principal Investigator: Yong Yin, Shanghai Children's Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2026

Primary Completion (Estimated)

January 31, 2028

Study Completion (Estimated)

January 31, 2028

Study Registration Dates

First Submitted

December 14, 2025

First Submitted That Met QC Criteria

January 29, 2026

First Posted (Actual)

February 3, 2026

Study Record Updates

Last Update Posted (Actual)

March 10, 2026

Last Update Submitted That Met QC Criteria

March 6, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SCMCIRB-YJ2025013

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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