Pulse Diagnosis, Sleep Disorders, Traditional Chinese Medicine Syndrome
Conditions
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
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.
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.
Interventions
DIAGNOSTIC_TESTThree-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_TESTExpert 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
Southern Medical University Hospital of Integrated Traditional Chinese and Western Medicine
Study design
Observational model
COHORT
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pulse Amplitude Index at the Six Pulse Positions | At the baseline study assessment visit | 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. |
| Pulse-Syndrome Concordance Assessed by Cosine Similarity | At the baseline study assessment visit | 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. |
| Diagnostic Consistency Between Electronic Pulse Diagnosis and Expert TCM Syndrome Differentiation | At the baseline study assessment visit | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Area Under the Receiver Operating Characteristic Curve for Electronic Pulse Diagnosis | At the baseline study assessment visit | 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. |
| Six-Image Pulse Distribution Patterns | At the baseline study assessment visit | 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. |
| Case-Based Six-Position Pulse Map Characteristics | At the baseline study assessment visit | 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. |
Countries
China
Outcome results
None listed