Study of CART BP Wearable Ring Device for Cuffless Blood Pressure Monitoring Compared to Traditional Method
Evaluating Accuracy by Arm Position and Exercise Effects in Adults 18 to 79 Years
Led by Sky Labs · Updated on 2025-06-15
50
Participants Needed
1
Research Sites
N/A
Total Duration
AI-Summary
What this Trial Is About
Researchers are evaluating the accuracy of the CART BP, a wearable cuffless blood pressure monitor, compared to the traditional auscultatory method using a dual-head stethoscope. This study follows the 2023 European Society of Hypertension recommendations and focuses on patients with suspected high or low blood pressure. The evaluation looks at measurements taken in different body positions and during various exercise activities.
Participants prescribed a 24-hour ambulatory blood pressure monitor will use both the CART BP ring device and a standard sphygmomanometer simultaneously to measure blood pressure and pulse rate. The study includes measurements with the arm positioned significantly lower than usual and after repeated handgrip exercises to assess changes in blood pressure accuracy under different conditions.
During the study, participants will have their blood pressure monitored continuously over a one-hour period, and researchers will measure the mean error and variability between the CART BP and the traditional method. Participants must comply with the study protocol and provide consent, with monitoring including exercise tests and posture changes. The total participation duration and follow-up details are consistent with the 24-hour blood pressure monitoring period.
CONDITIONS
Brief Title
Validation Study of CART BP as a Wearable Cuffless Blood Pressure Monitor
Research Team
G
Gerrard Kim
Y
Yujung Kang
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match. Sign up to get personalized trial recommendations delivered to your inbox.
Subjects aged 18 years or older but younger than 80 years
Individuals who voluntarily decide to participate in this clinical trial and provide written consent to the information and consent form
Individuals willing to comply with the clinical trial protocol
You will not qualify if you...
Subjects who do not consent to the study
Obese individuals with a Body Mass Index (BMI) of 30 or higher (concerns about measurement errors as the standard 24-hour ambulatory blood pressure monitor cuff may not fit the arm properly)
Patients or volunteers who are pregnant
Patients or volunteers with underlying heart diseases: those with a history of hospitalization for heart failure, valvular disease, or myocardial infarction
Patients or volunteers diagnosed with atrial fibrillation on a 12-lead electrocardiogram (ECG) within the past 6 months
Patients or volunteers with end-stage renal disease (undergoing dialysis)
Patients or volunteers unable to perform repeated exercises required for the study
Patients or volunteers with a systolic blood pressure (SBP) exceeding 160 millimeters of mercury (mmHg)
Patients or volunteers with a systolic blood pressure (SBP) exceeding 160 millimeters of mercury (mmHg) and/or a diastolic blood pressure (DBP) exceeding 100 millimeters of mercury (mmHg) (for exercise tests)
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Diagnostic Evaluation
Duration - Approximately 24 hours
Participants undergo blood pressure measurement using both the CART BP wearable device and a sphygmomanometer, following the 2023 European Society of Hypertension recommendations, including measurements at different arm positions and after physical exercises.
1 visit with 24-hour monitoring
Long-term Monitoring
Duration - 24 hours
Participants are observed during the 24-hour ambulatory blood pressure monitoring period using both devices to compare measurement accuracy.
Continuous monitoring over 24 hours
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
DIAGNOSTIC
Number of Arms
1
Similar Trials
Studying a 5-Minute Mindfulness Breathing Exercise Before Spinal Anesthesia in Pregnant Women Having Elective Cesarean Sections to Improve Blood Pressure Stability
AI-Assisted Smart Family Doctor for Managing Hypertension, Diabetes, and Dyslipidemia in Adults After Coronary Artery Bypass Graft or Percutaneous Coronary Intervention
PILI 0ina Project to Improve Diet and Health in Native Hawaiian Adults with Cardiometabolic Conditions Through Community Cooking Demonstrations
Study of the Eat Well Produce Prescription Program for Veterans with Hypertension, Diabetes, or Obesity at Risk of Food Insecurity
Study of Vascular Function and Blood Flow in Adults with Aging and Diseases Including COPD, Pulmonary Hypertension, Heart Failure, and Hypertension
A Program Combining Home Blood Pressure Monitoring, Community Support, and Telehealth to Improve Care for Adults with High Blood Pressure, Diabetes, or Kidney Disease
Observational Cohort Study of Biomarkers and Health Outcomes in Adults with Hypertension in Guangdong Province
PhytoRx Families Pilot Study to Improve Food Security and Increase Fruit and Vegetable Intake in Rural North Carolina
Evaluating a New Digital Tool to Help Doctors Personalize Exercise Prescriptions for Adults with Cardiovascular Risk Factors
A Long-Term Study of Chronic Diseases in Registered Nurses Working in Xiamen, China
Have more questions? Get in touch with our team for quick support
Published Research Related To This Trial
European Society of Hypertension recommendations for the validation of cuffless blood pressure measuring devices: European Society of Hypertension Working Group on Blood Pressure Monitoring and Cardiovascular Variability.
George S Stergiou, Alberto P Avolio, Paolo Palatini...