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

Condition(s) studied

Investigational drug(s) / intervention(s)

No intervention (observational study): No intervention (observational study)

Study 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.

Eligibility

Primary outcome measure(s)

• Association Between Tongue-Pulse Multimodal Features and Pulmonary Function in Pediatric Asthma — 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

Trial sites (1)

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