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

Seoul National University

Status: Enrolling

Conditions: Hypertension; Prehypertension; Diastolic Hypertension; Systolic Hypertension; Essential Hypertension; Obstructive Sleep Apnea; Blood Pressure

Treatments: Device: CART-I Plus

Study type: Interventional

Funder types: Other

Identifiers

NCT06084065

2305-064-1431

Details and patient eligibility

About

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.

Enrollment: 40 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Patients scheduled for 24-hour ambulatory blood pressure monitoring for diagnostic purposes among those suspected of having hypertension

2. 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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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40 participants in 1 patient group

Ring arm

Experimental group

Treatment:

Device: CART-I Plus