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

Sponsor
Shanghai Children's Medical Center
Study ID
NCT07383883
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
5 Years - 18 Years
Healthy Volunteers
Not accepted

Interventions

  • No intervention (observational study) — OTHER
    No intervention (observational study)

Study Details

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.

Key Dates

First listed
Feb 3, 2026
Start date
Feb 1, 2026
Status verified
Mar 2026
Primary completion
Jan 31, 2028
Completion
Jan 31, 2028

Study Design

Enrollment
1,000 participants (estimated)

Arms

  • Arm: 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.

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) ]

Central Contacts

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