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

Sponsor

Seoul National University Hospital (Other)

Overall Status

Recruiting

CT.gov ID

NCT06084065

Collaborator

(none)

Enrollment

Location

Arm

17.6

Anticipated Duration (Months)

2.3

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Hypertension Blood Pressure Systolic Hypertension Diastolic Hypertension Essential Hypertension Obstructive Sleep Apnea Prehypertension	Device: CART-I Plus	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

40 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Diagnostic

Official Title:

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

Actual Study Start Date :

Jul 13, 2023

Anticipated Primary Completion Date :

Dec 31, 2023

Anticipated Study Completion Date :

Dec 31, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Ring arm	Device: CART-I Plus Photoplethysmography based ring-type blood pressure measurement device

Arm

Intervention/Treatment

Experimental: Ring arm

Device: CART-I Plus

Photoplethysmography based ring-type blood pressure measurement device

Outcome Measures

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. [Compare the blood pressure measured over 24 hours using a ring-type blood pressure monitor and 24-hour ambulatory blood pressure monitoring.]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Seoul National Univesity Hospital	Seoul		Korea, Republic of

Sponsors and Collaborators

Seoul National University Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Hae-young Lee, Head of Cardiology, Seoul National University Hospital

ClinicalTrials.gov Identifier:

NCT06084065

Other Study ID Numbers:

2305-064-1431

First Posted:

Oct 16, 2023

Last Update Posted:

Oct 16, 2023

Last Verified:

Oct 1, 2023

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Sleep Apnea, Obstructive

Hypertension

Essential Hypertension

Prehypertension

Isolated Systolic Hypertension

Study Results

No Results Posted as of Oct 16, 2023