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

NCT07383883 | Recruiting DMC

• 1 other identifier: SCMCIRB-YJ2025013
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

Asthma

Keywords

asthma; Tongue-Pulse Diagnosis; Multimodal Phenotyping

Outcome Measures

Primary Outcomes (1)

• 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

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

Study Arms (1)

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)

Interventions

No intervention (observational study) OTHER

No intervention (observational study)

Pediatric Asthma Cohort

Eligibility Criteria

• Age: 5 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shanghai Children's Medical Center: lead

Study Sites (1)

Shanghai Children's Medical Center

Shanghai, 200127, China

RECRUITING

MeSH Terms

Conditions

Asthma

Interventions

Observation

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Methods; Investigative Techniques

Study Officials

• Yong Yin

  Shanghai Children's Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yong Yin

CONTACT

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: December 14, 2025
• First Posted: February 3, 2026
• Study Start: February 1, 2026
• Primary Completion (Estimated): January 31, 2028
• Study Completion (Estimated): January 31, 2028
• Last Updated: March 10, 2026

Record last verified: 2026-03

Locations

CN (1)