Feasibility and Effectiveness of a Ring-type Blood Pressure Measurement Device

Study Overview
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Brief Summary
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The goal of this clinical trial is to evaluate the feasibility and effectiveness of a ring-type blood pressure measurement device compared to a 24-hour ambulatory blood pressure monitoring device in patients with hypertension or suspected hypertension. The main question it aims to answer is whether the 24-hour blood pressure measurement accuracy of the ring-type blood pressure monitor is similar to that of the 24-hour ambulatory blood pressure monitor. To participate, subjects must wear a ring blood pressure monitor and an ambulatory blood pressure monitor simultaneously for 24 hours.

Official Title
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Feasibility and Effectiveness of a Ring-type Blood Pressure Measurement Device Compared With 24-hour Ambulatory Blood Pressure Monitoring Device: Pilot Study

Conditions
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Hypertension, Blood Pressure, Systolic Hypertension, Diastolic Hypertension, Essential Hypertension, Obstructive Sleep Apnea, Prehypertension

Intervention / Treatment
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* Device: CART-I Plus


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients scheduled for 24-hour ambulatory blood pressure monitoring for diagnostic purposes among those suspected of having hypertension Confirmed hypertensive patients scheduled for 24-hour ambulatory blood pressure monitoring for treatment purposes Either criterion 1 or 2 are planned to be selected as study participants. Exclusion Criteria: Participants who do not consent to the study Individuals with a Body Mass Index of 30 or above (there's a concern of measurement errors as the standard 24-hour ambulatory blood pressure cuffs may not fit well) Pregnancy Baseline heart disease patients: individuals with a history of hospitalization due to heart failure, valvular disease, or myocardial infarction Patients diagnosed with atrial fibrillation on a 12 lead EKG within the past 6 months End-stage renal disease (patients undergoing dialysis) Users of mobile phones that are not compatible with the test device (CART-I plus) used in the study

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ring arm<br> | Device: CART-I Plus<br>* Photoplethysmography based ring-type blood pressure measurement device<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The average agreement between blood pressure measured with a 24-hour ambulatory BP measurement device and blood pressure measured with a ring-type BP measurement device during a subject's activity time. |  | Compare the blood pressure measured over 24 hours using a ring-type blood pressure monitor and 24-hour ambulatory blood pressure monitoring. |