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

Primary Purpose

Hypertension, Blood Pressure, Systolic Hypertension

Status
Recruiting
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
CART-I Plus
Sponsored by
Seoul National University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Hypertension

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Seoul National Univesity HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Ring arm

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
October 5, 2023
Last Updated
October 11, 2023
Sponsor
Seoul National University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT06084065
Brief Title
Feasibility and Effectiveness of a Ring-type Blood Pressure Measurement Device
Official Title
Feasibility and Effectiveness of a Ring-type Blood Pressure Measurement Device Compared With 24-hour Ambulatory Blood Pressure Monitoring Device: Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 13, 2023 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Seoul National University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertension, Blood Pressure, Systolic Hypertension, Diastolic Hypertension, Essential Hypertension, Obstructive Sleep Apnea, Prehypertension

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Ring arm
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
CART-I Plus
Intervention Description
Photoplethysmography based ring-type blood pressure measurement device
Primary Outcome Measure Information:
Title
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.
Time Frame
Compare the blood pressure measured over 24 hours using a ring-type blood pressure monitor and 24-hour ambulatory blood pressure monitoring.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hae-Young Lee, Professor
Phone
+82-02-2072-0698
Email
hylee612@snu.ac.kr
First Name & Middle Initial & Last Name or Official Title & Degree
Huijin Lee, Clinical Fellow
Email
gmlwls0227@gmail.com
Facility Information:
Facility Name
Seoul National Univesity Hospital
City
Seoul
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hae-Young Lee, Professor
Phone
+82-02-2072-0698
Email
hylee612@snu.ac.kr
First Name & Middle Initial & Last Name & Degree
Huijin Lee, Clinical Fellow
Email
gmlwls0227@gmail.com

12. IPD Sharing Statement

Learn more about this trial

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

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