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

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

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.

Study Overview

• Status: Completed
• Conditions: Sleep Disorders; Pulse Diagnosis; Traditional Chinese Medicine Syndrome
• Intervention / Treatment: Diagnostic test: Three-Dimensional Electronic Pulse Diagnosis; Diagnostic test: Expert Traditional Chinese Medicine Syndrome Differentiation

Detailed Description

This study was conducted at the Integrated Traditional Chinese and Western Medicine Hospital of Southern Medical University. It was designed as a prospective, single-center, observational diagnostic accuracy study to explore the relationship between objective pulse diagnostic parameters and traditional Chinese medicine syndrome differentiation in patients with sleep disorders.

Eligible participants were adult patients with sleep disorders who were able to complete pulse examination and questionnaire assessment and who provided written informed consent. Patients with acute disease, severe organic cardiovascular disease, anatomical abnormalities of the radial artery, pregnancy, or other conditions unsuitable for pulse signal acquisition were excluded.

Each participant completed a standardized Six-Image Symptom Questionnaire developed according to the traditional Chinese medicine zang-fu image framework. The questionnaire covered six functional image domains, including heart, liver, spleen, lung, kidney, and San Jiao or mingmen-related domains. Expert traditional Chinese medicine syndrome differentiation was independently performed by two senior traditional Chinese medicine physicians. If disagreement occurred, a third senior expert adjudicated the final predominant syndrome, which served as the reference standard.

Pulse signals were acquired using the KY-M-A1 three-dimensional electronic pulse diagnostic system. Bilateral pulse signals were collected from the cun, guan, and chi positions, yielding six pulse sites in total. Participants rested quietly before acquisition, and pulse signals were recorded under standardized conditions. The system extracted pulse waveform parameters, including pulse amplitude-related indices, to construct a Six-Image pulse vector.

The primary analysis evaluates pulse-syndrome concordance by comparing the Six-Image pulse vector with the symptom-based Six-Image vector using cosine similarity. Higher similarity values indicate stronger agreement between pulse-derived features and symptom-based syndrome domains. Expert-determined traditional Chinese medicine syndrome classification is used as the reference standard. Secondary analyses include the diagnostic consistency between instrument-based syndrome differentiation and expert assessment, as well as receiver operating characteristic curve analysis to evaluate the discriminatory performance of the electronic pulse diagnostic system.

• Study Type: Observational
• Enrollment (Actual): 201

Contacts and Locations

Study Locations

• China
  • Guangdon
    • Guangzhou, Guangdon, China, 510000
      • Integrated Traditional Chinese and Western Medicine Hospital of Southern Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• 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.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

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; 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.; Other Names: KY-M-A1; Electronic Pulse Diagnostic System; Six-Image Pulse Diagnosis; 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.; Other Names: Expert TCM Syndrome Assessment; Reference Standard Syndrome Differentiation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Area Under the Receiver Operating Characteristic Curve for Electronic Pulse Diagnosis	Receiver operating characteristic curve analysis was performed to evaluate the discriminatory performance of pulse-syndrome concordance and instrument-based syndrome classification. The area under the curve was calculated to quantify overall diagnostic discrimination.	At the baseline study assessment visit
Six-Image Pulse Distribution Patterns	Six-Image radar plots and distribution heat maps were used to visualize Pulse Amplitude Index patterns across the six pulse positions and to characterize pulse distribution patterns corresponding to different traditional Chinese medicine syndrome domains.	At the baseline study assessment visit
Case-Based Six-Position Pulse Map Characteristics	Representative case-level Six-Image pulse maps were generated using Pulse Amplitude Index values from the six pulse positions to illustrate the individualized application of electronic pulse diagnosis in traditional Chinese medicine syndrome differentiation.	At the baseline study assessment visit

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2025
• Primary Completion (Actual): September 30, 2025
• Study Completion (Actual): September 30, 2025

Study Registration Dates

• First Submitted: July 4, 2026
• First Submitted That Met QC Criteria: July 4, 2026
• First Posted (Actual): July 10, 2026

Study Record Updates

• Last Update Posted (Actual): July 10, 2026
• Last Update Submitted That Met QC Criteria: July 4, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Keywords: Sleep Disorders; Diagnostic Accuracy Study; Three-Dimensional Electronic Pulse Diagnosis; Six-Image Pulse Map; Pulse Amplitude Index; Traditional Chinese Medicine Syndrome Differentiation; Pulse-Syndrome Concordance; KY-M-A1; Cosine Similarity; Cun Guan Chi Pulse Positions
• Additional Relevant MeSH Terms: Neurologic Manifestations; Nervous System Diseases; Mental Disorders; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Sleep Wake Disorders
• Other Study ID Numbers: SMUIMH-PULSE-202310K1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

IPD Plan Description

No individual participant data will be shared publicly. The study dataset includes participant-level clinical information, traditional Chinese medicine symptom questionnaire data, expert syndrome differentiation results, and electronic pulse signal parameters. These data were collected under institutional ethics approval and written informed consent for the present study, and public or external sharing of individual participant data was not included in the consent materials.

Requests for de-identified aggregate data or additional methodological information may be directed to the principal investigator, Mingpeng Luo, at 872462051@qq.com. Any data access request will be reviewed by the study team and will be subject to institutional policy and ethics committee approval.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No