NCT07383883 Multimodal Tongue-Pulse Information Fusion for Syndrome Diagnosis and Cohort Study in Children With Asthma

Trial Parameters

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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.

Eligibility Criteria

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.

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