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

ConditionAsthma
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age5-18
SponsorShanghai Children's Medical Center

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial 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.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • No intervention (observational study)

    Other intervention

    No intervention (observational study)

Treatment groups

1,000 Participants
are divided into 1 treatment group
Group A: Pediatric Asthma Cohort1 intervention

Trial outcomes

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

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

Secondary outcomes

Other outcomes

Sponsors and contacts

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