Validation of the Blood Pressure Monitoring Function

NCT06104501 | Unknown

• 1 other identifier: Validation of Blood Pressure
• Study Type: observational
• Target: 170
• Locations: 0 countries
• Sites: N/A

Brief Summary

High blood pressure is a major risk factor for cardiovascular diseases, stroke, and kidney disorders. Accurate blood pressure monitoring is crucial for the diagnosis, treatment, and prevention of complications related to high blood pressure. In recent years, due to the rapid development of wearable devices and mobile technology, wearable blood pressure monitors have gradually become a non-invasive and convenient method for blood pressure monitoring. However, the accuracy of these devices has not been fully established. This study aims to validate the performance of RadiHeart (an application program) in blood pressure measurement.

Conditions

Blood Pressure

Keywords

Artificial Intelligence(AI) Algorithm; blood pressure

Outcome Measures

Primary Outcomes (2)

• Difference in blood pressure (mean)

  The mean value of the differences in blood pressure measured by RadiHeart and the reference sphygmomanometer should be within or equal to ±5.0 mmHg.

  1 hour per individual

• Difference in blood pressure (standard deviation)

  The standard deviation of the differences in blood pressure measured by RadiHeart and the reference sphygmomanometer should be no greater than 8.0 mmHg.

  1 hour per individual

Interventions

RadiHeart DEVICE

The participants' blood pressure will be measured multiple times by both the mercury sphygmomanometer and RadiHeart, by using the same arm sequential method.

Eligibility Criteria

• Age: 20 Years - 99 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

This trial expects to enroll 170 participants. The subjects should be aged 20 or older, with an equal gender distribution of 50% male and 50% female. From this group, 85 subjects with reasonable data values will be selected, with a requirement that at least 30% of them are male and at least 30% are female.

You may qualify if:

• The subjects should be aged 20 or older, with an equal gender distribution of 50% male and 50% female. From this group, 85 subjects with reasonable data values will be selected, with a requirement that at least 30% of them are male and at least 30% are female. Additionally, they must meet the following blood pressure conditions:
• At least 5% (5 individuals) of the participants should have reference systolic blood pressure readings ≥ 160 mmHg (21.33 kPa).
• At least 20% (17 individuals) of the participants should have reference systolic blood pressure readings ≥ 140 mmHg (18.66 kPa).
• At least 5% (5 individuals) of the participants should have reference systolic blood pressure readings ≤ 100 mmHg (13.33 kPa).
• At least 5% (5 individuals) of the participants should have reference diastolic blood pressure readings ≤ 60 mmHg (8.0 kPa).
• At least 20% (17 individuals) of the participants should have reference diastolic blood pressure readings ≥ 85 mmHg (11.33 kPa).
• At least 5% (5 individuals) of the participants should have reference diastolic blood pressure readings ≥ 100 mmHg (13.33 kPa).

You may not qualify if:

• Pregnant.
• Having any of the following conditions:
• Arrhythmia
• Medical assessment indicates that poor blood circulation would affect the blood pressure data collection.
• Involuntary hand movements that would affect the blood pressure data collector.
• Nail polish on the light sensor area of the fingertip oximeter.
• Other conditions as determined by a physician that make the individual unsuitable for participation in the trial.

Sponsors & Collaborators

• RadiRad Co., Ltd.: lead
• Hualien Tzu Chi General Hospital: collaborator

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 16, 2023
• First Posted: October 27, 2023
• Study Start: October 20, 2023
• Primary Completion: December 31, 2023
• Study Completion: May 31, 2024
• Last Updated: October 27, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share