Sleep DisordersSIP-TCMNCT07695103
Electronic Six-Image Pulse Diagnosis for TCM Syndrome Identification in Sleep Disorders
An observational study of Sleep Disorders and Traditional Chinese Medicine Syndrome, run by Southern Medical University Hospital of Integrated Traditional Chinese and Western Medicine at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Sleep Disorders, Traditional Chinese Medicine Syndrome, Pulse Diagnosis
- What is being tested?
- Three-Dimensional Electronic Pulse Diagnosis and Expert Traditional Chinese Medicine Syndrome Differentiation
- How many people
- 201 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2025to 30 Sep 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
Integrated Traditional Chinese and Western Medicine Hospital of Southern Medical University
Guangzhou, Guangdon, 510000
About this study
Official title: 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.
Read the 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.
- Being tested
- Three-Dimensional Electronic Pulse Diagnosis, Expert Traditional Chinese Medicine Syndrome Differentiation
- 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
- Medical subject headings
- Sleep Wake Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Three-Dimensional Electronic Pulse DiagnosisDiagnostic test
Also called KY-M-A1, Electronic Pulse Diagnostic System, Six-Image 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.
Expert Traditional Chinese Medicine Syndrome DifferentiationDiagnostic test
Also called Expert TCM Syndrome Assessment, Reference Standard 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Diagnostic Test: Three-Dimensional Electronic Pulse Diagnosis; Diagnostic Test: Expert Traditional Chinese Medicine Syndrome Differentiation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: At the baseline study assessment visit
Secondary outcomes (3)
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.
Measured: 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.
Measured: 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.
Measured: At the baseline study assessment visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2026
- Study start1 Jan 2025
- Primary completion30 Sep 2025
- Study completion30 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sleep DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 201 participants (actual)
Sponsor and investigators
- Lead sponsor
- Southern Medical University Hospital of Integrated Traditional Chinese and Western Medicine
- Sponsor type
- Other government
- Responsible party
- Principal investigator, MingPeng Luo, Southern Medical University Hospital of Integrated Traditional Chinese and Western Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07695103
- Sponsor's protocol ID
- SMUIMH-PULSE-202310K1
- Acronym
- SIP-TCM
- Status last verified
- Jul 2026
- First submitted
- 4 Jul 2026
- Last updated
- 10 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07695103
- Acronym / sponsor ID
- SIP-TCM / SMUIMH-PULSE-202310K1
- 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
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 201 participants (actual)
- Lead sponsor
- Southern Medical University Hospital of Integrated Traditional Chinese and Western MedicineOther government
- Study start
- 1 Jan 2025 (actual)
- Primary completion
- 30 Sep 2025 (actual)
- Study completion
- 30 Sep 2025 (actual)
- First posted
- 10 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients With Sleep Disorders | – | Diagnostic Test: Three-Dimensional Electronic Pulse Diagnosis, Diagnostic Test: Expert Traditional Chinese Medicine Syndrome DifferentiationAdult 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Three-Dimensional Electronic Pulse DiagnosisAlso: KY-M-A1, Electronic Pulse Diagnostic System, Six-Image Pulse DiagnosisAll 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 test | Patients With Sleep Disorders |
| Expert Traditional Chinese Medicine Syndrome DifferentiationAlso: Expert TCM Syndrome Assessment, Reference Standard Syndrome DifferentiationAll 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. | Diagnostic test | Patients With Sleep Disorders |
Primary outcome
Pulse Amplitude Index at the Six Pulse Positions
Time frame: 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
Time frame: 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
Time frame: 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.
3 secondary outcomes
Area Under the Receiver Operating Characteristic Curve for Electronic Pulse Diagnosis
Time frame: At the baseline study assessment visit
Six-Image Pulse Distribution Patterns
Time frame: At the baseline study assessment visit
Case-Based Six-Position Pulse Map Characteristics
Time frame: At the baseline study assessment visit
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2026.
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sleep Disorders and Traditional Chinese Medicine Syndrome, run by Southern Medical University Hospital of Integrated Traditional Chinese and Western Medicine at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pulse Amplitude Index at the Six Pulse Positions (time frame: At the baseline study assessment visit). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jul 2026.