Blood Pressure, Diastolic Hypertension, Essential Hypertension, Hypertension, Obstructive Sleep Apnea, Prehypertension, Systolic Hypertension
Conditions
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.
Interventions
DEVICECART-I Plus
Photoplethysmography based ring-type blood pressure measurement device
Sponsors
Seoul National University Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. |
Countries
South Korea
Contacts
Primary ContactHae-Young Lee, Professor
Backup ContactHuijin Lee, Clinical Fellow
Outcome results
None listed