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

NCT07695103 | Completed

• 1 other identifier: SMUIMH-PULSE-202310K1
• Study Type: observational
• Target: 201
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Three-Dimensional Electronic Pulse Diagnosis; Six-Image Pulse Map; Pulse Amplitude Index; Traditional Chinese Medicine Syndrome Differentiation; Pulse-Syndrome Concordance; Diagnostic Accuracy Study; KY-M-A1; Cosine Similarity; Cun Guan Chi Pulse Positions; Sleep Disorders

Outcome Measures

Primary Outcomes (3)

• Pulse Amplitude Index at the Six Pulse Positions

  The Pulse Amplitude Index was derived from pulse signals acquired by the KY-M-A1 three-dimensional electronic pulse diagnostic system at the bilateral cun, guan, and chi positions. Pulse Amplitude Index values from the six pulse positions were used to objectively characterize pulse wave amplitude distribution and construct the Six-Image pulse vector.

  At the baseline study assessment visit

• Pulse-Syndrome Concordance Assessed by Cosine Similarity

  Pulse-syndrome concordance was quantified using cosine similarity between the Six-Image pulse vector derived from electronic pulse diagnostic parameters and the Six-Image symptom vector derived from structured traditional Chinese medicine symptom assessment. The similarity score ranges from 0 to 1, with higher values indicating greater concordance between pulse-derived features and symptom-based syndrome domains.

  At the baseline study assessment visit

• Diagnostic Consistency Between Electronic Pulse Diagnosis and Expert TCM Syndrome Differentiation

  Diagnostic consistency was evaluated by comparing instrument-based syndrome differentiation with expert-determined traditional Chinese medicine syndrome classification. Expert syndrome differentiation served as the reference standard. Consistency was assessed using sensitivity, specificity, and overall accuracy.

  At the baseline study assessment visit

Secondary Outcomes (3)

• Area Under the Receiver Operating Characteristic Curve for Electronic Pulse Diagnosis

  At the baseline study assessment visit

• Six-Image Pulse Distribution Patterns

  At the baseline study assessment visit

• Case-Based Six-Position Pulse Map Characteristics

  At the baseline study assessment visit

Study Arms (1)

Patients With Sleep Disorders

Adult patients with sleep disorders who provided written informed consent and underwent standardized Six-Image symptom questionnaire assessment, expert traditional Chinese medicine syndrome differentiation, and bilateral cun, guan, and chi pulse signal acquisition using the KY-M-A1 three-dimensional electronic pulse diagnostic system. No treatment intervention was assigned in this observational diagnostic accuracy study.

Diagnostic Test: Three-Dimensional Electronic Pulse Diagnosis; Diagnostic Test: Expert Traditional Chinese Medicine Syndrome Differentiation

Interventions

Three-Dimensional Electronic Pulse Diagnosis DIAGNOSTIC_TEST

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.

Also known as: KY-M-A1, Electronic Pulse Diagnostic System, Six-Image Pulse Diagnosis

Patients With Sleep Disorders

Expert Traditional Chinese Medicine Syndrome Differentiation DIAGNOSTIC_TEST

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.

Also known as: Expert TCM Syndrome Assessment, Reference Standard Syndrome Differentiation

Patients With Sleep Disorders

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population consisted of adult outpatients and inpatients with sleep disorders recruited from the Integrated Traditional Chinese and Western Medicine Hospital of Southern Medical University. Eligible participants had relatively stable symptoms, were able to complete the standardized Six-Image symptom questionnaire and electronic pulse examination, and provided written informed consent. All participants underwent expert traditional Chinese medicine syndrome differentiation and bilateral cun, guan, and chi pulse signal acquisition using the KY-M-A1 three-dimensional electronic pulse diagnostic system.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (1)

Integrated Traditional Chinese and Western Medicine Hospital of Southern Medical University

Guangzhou, Guangdon, 510000, China

Location

MeSH Terms

Conditions

Sleep Wake Disorders

Condition Hierarchy (Ancestors)

Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 4, 2026
• First Posted: July 10, 2026
• Study Start: January 1, 2025
• Primary Completion: September 30, 2025
• Study Completion: September 30, 2025
• Last Updated: July 10, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)