MedTrace Logo

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

NCT07695103 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 201

Last updated 2026-07-10

No results posted yet for this study

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.

Conditions

  • Sleep Disorders
  • Traditional Chinese Medicine Syndrome
  • Pulse Diagnosis

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.

Sponsors & Collaborators

  • Southern Medical University Hospital of Integrated Traditional Chinese and Western Medicine

    lead OTHER_GOV

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-01-01
Primary Completion
2025-09-30
Completion
2025-09-30

Countries

  • China

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07695103 on ClinicalTrials.gov