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.

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.

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.

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.

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.