RecruitingNot ApplicableNCT06513975

Validation Study of CART BP as a Wearable Cuffless Blood Pressure Monitor

Validation Study of CART BP as a Wearable Cuffless Blood Pressure Monitor: Evaluation of Blood Pressure Measurement by Height and Physical Activity


Sponsor

Sky Labs

Enrollment

50 participants

Start Date

Nov 22, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

This study aims to evaluate the accuracy of the CART BP, a medically approved ring-type blood pressure monitor, in comparison to the traditional auscultatory method using a dual-head stethoscope. The comparison is conducted in accordance with the 2023 European Society of Hypertension (ESH) Recommendations, focusing on patients with suspected hypertension or hypotension. The evaluation includes accuracy measurements across various postures and during different exercise periods.


Eligibility

Min Age: 18 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This study is testing the accuracy of a new wearable blood pressure monitor called CART BP that does not require an arm cuff, comparing its readings against a standard 24-hour ambulatory (wearable cuff) blood pressure device. **You may be eligible if...** - You are between 18 and 80 years old - You are willing to wear both monitoring devices and follow the study protocol - You can provide written informed consent **You may NOT be eligible if...** - You are obese (BMI of 30 or higher) - You are pregnant - You have a history of hospitalization for heart failure, heart valve disease, or heart attack - You have been diagnosed with atrial fibrillation in the past 6 months - You have end-stage kidney disease and are on dialysis - You are unable to perform repeated exercise tests Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICECART BP

A ring-type medical device worn by the subject that non-invasively measures systolic and diastolic blood pressure, as well as pulse rate.

DEVICEsphygmomanometer

Blood pressure measurement method utilizing a two-headed stethoscope, allowing two observers to simultaneously hear the Korotkoff sounds.


Locations(1)

Samsung Medical Center

Seoul, South Korea

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NCT06513975


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