Evaluating a new ring-type device for measuring blood pressure
Feasibility and Effectiveness of a Ring-type Blood Pressure Measurement Device Compared With 24-hour Ambulatory Blood Pressure Monitoring Device: Pilot Study
This study is testing a new ring device for measuring blood pressure to see if it works as well as the standard 24-hour monitor in people with high blood pressure.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | Seoul National University Hospital Academic / other |
| Drugs / interventions | CART |
| Locations | 1 site (Seoul) |
| Trial ID | NCT06084065 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to assess the feasibility and effectiveness of a ring-type blood pressure measurement device in comparison to a traditional 24-hour ambulatory blood pressure monitor in patients with hypertension or suspected hypertension. Participants will wear both devices simultaneously for 24 hours to determine if the accuracy of the ring device matches that of the standard monitor. The study focuses on patients who are either scheduled for diagnostic or treatment purposes related to hypertension.
Who should consider this trial
Good fit: Ideal candidates include patients scheduled for 24-hour ambulatory blood pressure monitoring due to suspected or confirmed hypertension.
Not a fit: Patients with a Body Mass Index of 30 or above, certain heart conditions, or those who are pregnant will not benefit from this study.
Why it matters
Potential benefit: If successful, this device could provide a more convenient and accurate method for monitoring blood pressure in patients with hypertension.
How similar studies have performed: While similar studies have explored blood pressure monitoring devices, the specific ring-type approach is relatively novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Seoul
- Seoul National Univesity Hospital — Seoul, Korea, Republic of (Recruiting)
Study contacts
- Study coordinator: Hae-Young Lee, Professor
- Email: hylee612@snu.ac.kr
- Phone: +82-02-2072-0698
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.