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COMPLETED
NCT07695103

Electronic Six-Image Pulse Diagnosis for TCM Syndrome Identification in Sleep Disorders

Sponsor: Southern Medical University Hospital of Integrated Traditional Chinese and Western Medicine

View on ClinicalTrials.gov

Summary

This is a prospective, single-center, observational diagnostic accuracy study designed to evaluate whether three-dimensional electronic pulse diagnosis can support traditional Chinese medicine syndrome identification in patients with sleep disorders. Participants underwent standardized symptom assessment, expert traditional Chinese medicine syndrome differentiation, and bilateral cun, guan, and chi pulse signal acquisition using the KY-M-A1 electronic pulse diagnostic system. Six-position pulse parameters were used to construct a Six-Image pulse vector, which was compared with a symptom-based Six-Image vector. The main purpose of the study is to assess the concordance between electronic pulse-derived features and expert-determined traditional Chinese medicine syndromes.

Official title: From Experience to Evidence: Large-Sample Quantitative Modeling of the Six-Image Pulse Framework Using a Modern Pulse Diagnostic Device and Its Performance in TCM Syndrome Identification

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

OBSERVATIONAL

Enrollment

201

Start Date

2025-01-01

Completion Date

2025-09-30

Last Updated

2026-07-10

Healthy Volunteers

No

Interventions

DIAGNOSTIC_TEST

Three-Dimensional Electronic Pulse Diagnosis

All participants underwent bilateral cun, guan, and chi pulse signal acquisition using the KY-M-A1 three-dimensional electronic pulse diagnostic system. The diagnostic test was used to obtain six-position pulse parameters and construct a Six-Image pulse vector for comparison with symptom-based Six-Image vectors and expert traditional Chinese medicine syndrome classification. No treatment intervention was assigned in this observational diagnostic accuracy study.

DIAGNOSTIC_TEST

Expert Traditional Chinese Medicine Syndrome Differentiation

All participants underwent expert traditional Chinese medicine syndrome differentiation based on symptom profiles, tongue assessment, pulse palpation, and clinical evaluation. Syndrome differentiation was independently performed by two senior traditional Chinese medicine physicians. In cases of disagreement, a third senior expert adjudicated the final predominant syndrome. The expert-determined syndrome classification served as the reference standard for evaluating the diagnostic performance of the electronic pulse diagnostic system.

Locations (1)

Integrated Traditional Chinese and Western Medicine Hospital of Southern Medical University

Guangzhou, Guangdon, China