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Completed NCT07695103

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

Conditions: Sleep Disorders, Traditional Chinese Medicine Syndrome, Pulse Diagnosis

Sex: All
Ages: 18 Years – 75 Years
Healthy volunteers: No
Enrollment: 201
Sponsor: Southern Medical University Hospital of Integrated Traditional Chinese and Western Medicine

Location: Integrated Traditional Chinese and Western Medicine Hospital of Southern Medical University Guangzhou Guangdon

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.

Eligibility Criteria

Inclusion Criteria: * Age between 18 and 75 years, regardless of sex. * Confirmed diagnosis of sleep disorder with relatively stable symptoms. * Ability to complete electronic pulse examination and questionnaire assessment. * Provision of written informed consent. Exclusion Criteria: * Acute phase of disease. * Severe organic cardiovascular disease, such as severe arrhythmia or heart failure. * Anatomical abnormalities of the radial artery or difficulty in pulse signal acquisition. * Pregnancy. * Other conditions considered unsuitable for pulse data acquisition by the investigators.

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07695103). StuddyBuddy aggregates publicly available trial information.