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Validation Study of an Assistive Pulse Data Collection Device

Study on Pulse Recognition Using an Investigational Device

Recruiting
18-65 years
All
Phase 1

This study investigates how well a device can recognize and regenerate pulse features from individuals. The purpose is to see if the device's pulse matches the natural pulse of the subjects. The study involves two phases: a Feasibility Phase, where user experiences from both the device and subjects are collected to refine the device settings, and a Pilot Phase, where the refined procedure is tested with more participants.

Participants will have their pulse features recorded by the device. Three trained practitioners, known as CMPs, will evaluate the pulse from both hands and the regenerated pulse from the device. They will rate the similarity in frequency, rhythm, wideness, and force using a 5-point scale. Subjects will also fill out a questionnaire about their experience. This process will be repeated until feedback from a specified number of subjects and CMPs is collected.

  • Who can participate: Individuals aged 18 to 65 years with a BMI between 18.5 and 22.5 kg/m² who are willing to give informed consent can participate. Those with a dorsally located radial artery are excluded.
  • Study details: Participants will have their pulse assessed by practitioners and a device. The device will regenerate the pulse, and practitioners will compare it to the original. Participants will complete questionnaires about their experience. A placebo is not used in this study.
Study details
    Healthy Male and Female Subjects

NCT06974227

The Hong Kong Polytechnic University

15 May 2025

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