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

Not Applicable

Recruiting

• Conditions: Systolic Hypertension; Prehypertension; Blood Pressure; Obstructive Sleep Apnea; Hypertension; Diastolic Hypertension; Essential Hypertension
• Interventions: Device: CART-I Plus

• Registration Number: NCT06084065
• Lead Sponsor: Seoul National University Hospital

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-07-13
• Status Verified: 2023-10
• Study First Submitted: 2023-10-05
• Study First Submitted QC: 2023-10-11
• Last Update Submitted: 2023-10-11
• Study First Posted: 2023-10-16
• Last Update Posted: 2023-10-16
• Primary Completion: 2023-12-31
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Ring arm	CART-I Plus	-

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Seoul National Univesity Hospital; 🇰🇷 Seoul, Korea, Republic of