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

Hypertension Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06084065
• Other study ID #: 2305-064-1431
• Status: Recruiting
• Phase: N/A
• Start date: July 13, 2023
• Est. completion date: December 31, 2024

Study information

• Verified date: October 2023
• Source: Seoul National University Hospital
• Contact: Hae-Young Lee, Professor
• Phone: +82-02-2072-0698
• Email: hylee612[@]snu.ac.kr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Blood Pressure
• Diastolic Hypertension
• Essential Hypertension
• Hypertension
• Isolated Systolic Hypertension
• Obstructive Sleep Apnea
• Prehypertension
• Sleep Apnea, Obstructive
• Systolic Hypertension

Intervention

Device:
• CART-I Plus
Photoplethysmography based ring-type blood pressure measurement device

Locations

Country	Name	City	State
Korea, Republic of	Seoul National Univesity Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.