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Validation Study of an Assistive Pulse Data Collection Device

NCT06974227 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2025-05-15

No results posted yet for this study

Summary

Background: Traditional Chinese Medicine (TCM) relies on pulse diagnosis, a subjective and complex method that is crucial for assessing patients' health status. The COVID-19 pandemic has disrupted healthcare delivery, highlighting the need for remote diagnostic tools. To address this, an Assistive Pulse Data Collection Device (APDC) has been developed to capture and regenerate pulse features for remote pulse assessment in TCM.

Objective: This study aims to validate the accuracy and reliability of the APDC by assessing its agreement with Chinese Medicine Practitioners (CMPs) and collecting users' feedback.

Intervention: The APDC consists of a radial artery viewing device, pulse collection device, and pulse regeneration device.

Methods: Subjects will be recruited via social media and posters at the University. Inclusion criteria include age 18-65 years and BMI 18.5-22.5 kg/m2, while exclusion criteria include a dorsally located radial artery. Registered CMPs with at least 5 years of clinical experience will assess the pulse from both participants and the regenerated pulse by the device.

Outcome Assessment: Agreement in pulse features between the subjects' real pulse and the pulse regeneration device will be assessed using a self-developed questionnaire, covering frequency, rhythm, wideness, and force. Quantitative and qualitative feedback from subjects and CMPs will be collected to assess their views on the APDC Device in terms of satisfaction, ease of use, and comfortability.

Conditions

  • Healthy Male and Female Subjects

Interventions

DEVICE

Assistive Pulse Data Collection (APDC) Device

An Assistive Pulse Data Collection Device prototype has been designed and manufactured by the Logistics and Supply Chain MultiTech R\&D Centre, Hong Kong. The device comprises a pulse sensor to record the patient's pulse and digitalize the pulse feature into waveform data. The digitalized waveform data is then converted the electronic signal into mechanical vibration that responds to the patient's pulse.

Sponsors & Collaborators

  • Logistics and Supply Chain MultiTech R&D Centre, Hong Kong

    collaborator UNKNOWN

  • The Hong Kong Polytechnic University

    lead OTHER

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-03-20
Primary Completion
2025-06-30
Completion
2025-07-31

Countries

  • Hong Kong

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06974227 on ClinicalTrials.gov