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
Descripción general del estudio
Estado
Descripción detallada
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.
Tipo de estudio
Inscripción (Actual)
Contactos y Ubicaciones
Ubicaciones de estudio
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Guangdon
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Guangzhou, Guangdon, Porcelana, 510000
- Integrated Traditional Chinese and Western Medicine Hospital of Southern Medical University
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Método de muestreo
Población de estudio
Descripción
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.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
Cohortes e Intervenciones
Grupo / Cohorte |
Intervención / Tratamiento |
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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.
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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.
Otros nombres:
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.
Otros nombres:
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Pulse Amplitude Index at the Six Pulse Positions
Periodo de tiempo: At the baseline study assessment visit
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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.
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At the baseline study assessment visit
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Pulse-Syndrome Concordance Assessed by Cosine Similarity
Periodo de tiempo: At the baseline study assessment visit
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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.
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At the baseline study assessment visit
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Diagnostic Consistency Between Electronic Pulse Diagnosis and Expert TCM Syndrome Differentiation
Periodo de tiempo: At the baseline study assessment visit
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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.
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At the baseline study assessment visit
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Area Under the Receiver Operating Characteristic Curve for Electronic Pulse Diagnosis
Periodo de tiempo: At the baseline study assessment visit
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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.
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At the baseline study assessment visit
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Six-Image Pulse Distribution Patterns
Periodo de tiempo: At the baseline study assessment visit
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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.
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At the baseline study assessment visit
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Case-Based Six-Position Pulse Map Characteristics
Periodo de tiempo: At the baseline study assessment visit
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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.
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At the baseline study assessment visit
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Colaboradores e Investigadores
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- SMUIMH-PULSE-202310K1
Plan de datos de participantes individuales (IPD)
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Descripción del plan IPD
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.
Información sobre medicamentos y dispositivos, documentos del estudio
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