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

NCT06084065 | Unknown

• 1 other identifier: 2305-064-1431
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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.

Study Arms (1)

Ring arm

EXPERIMENTAL

Device: CART-I Plus

Interventions

CART-I Plus DEVICE

Photoplethysmography based ring-type blood pressure measurement device

Ring arm

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Seoul National University Hospital: lead

Study Sites (1)

Seoul National Univesity Hospital

Seoul, South Korea

RECRUITING

Related Publications (1)

• Lee H, Park S, Kwon H, Cho B, Park JH, Lee HY. Feasibility and Effectiveness of a Ring-Type Blood Pressure Measurement Device Compared With 24-Hour Ambulatory Blood Pressure Monitoring Device. Korean Circ J. 2024 Feb;54(2):93-104. doi: 10.4070/kcj.2023.0303. Epub 2023 Dec 26.

  PMID: 38196118 DERIVED

MeSH Terms

Conditions

Hypertension; Isolated Systolic Hypertension; Essential Hypertension; Sleep Apnea, Obstructive; Prehypertension

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Central Study Contacts

Hae-Young Lee, Professor

CONTACT

+82-02-2072-0698; hylee612@snu.ac.kr

Huijin Lee, Clinical Fellow

CONTACT

gmlwls0227@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Cardiology

Study Record Dates

• First Submitted: October 5, 2023
• First Posted: October 16, 2023
• Study Start: July 13, 2023
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2024
• Last Updated: October 16, 2023

Record last verified: 2023-10

Locations

KR (1)