Electronic Six-Image Pulse Diagnosis for TCM Syndrome Identification in Sleep Disorders (NCT07695103) | Clinical Trial Compass
CompletedNot Applicable
Electronic Six-Image Pulse Diagnosis for TCM Syndrome Identification in Sleep Disorders
China201 participantsStarted 2025-01-01
Plain-language 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.
Who can participate
Age range
18 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Pulse Amplitude Index at the Six Pulse Positions
Timeframe: At the baseline study assessment visit
2
Pulse-Syndrome Concordance Assessed by Cosine Similarity
Timeframe: At the baseline study assessment visit
3
Diagnostic Consistency Between Electronic Pulse Diagnosis and Expert TCM Syndrome Differentiation
Timeframe: At the baseline study assessment visit
Trial details
NCT IDNCT07695103
SponsorSouthern Medical University Hospital of Integrated Traditional Chinese and Western Medicine