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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-07-13

Study Completion Date

2024-12-31

Brief Summary

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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.

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Detailed Description

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Conditions

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

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Ring arm

Group Type EXPERIMENTAL

CART-I Plus

Intervention Type DEVICE

Photoplethysmography based ring-type blood pressure measurement device

Interventions

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CART-I Plus

Photoplethysmography based ring-type blood pressure measurement device

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No