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
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 201
- 试验地点
- 1
- 主要终点
- Pulse Amplitude Index at the Six Pulse Positions
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Pulse Amplitude Index at the Six Pulse Positions
时间窗: 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
时间窗: 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
时间窗: 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.
次要结局
- 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)
研究者
MingPeng Luo
Principal Investigator
Southern Medical University Hospital of Integrated Traditional Chinese and Western Medicine