NCT05601414

Blood Pressure Monitoring in Hypertensive Populations: Device Testing, Feasibility, Acceptability

Cuff-less Wearable Blood Pressure Monitoring Device Validation

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 41 (actual)
• Sponsor: Yale University · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The goal of this study is to test a novel cuffless blood pressure (BP) monitoring device (BIO-Z) within adults with hypertension (high blood pressure) for clinical use. The main questions it aims to answer are: * To validate a novel cuffless blood pressure (BP) monitoring device (BIO-Z) within adults with hypertension (high blood pressure) * To assess BP monitoring accuracy, against reference BP measurements captured by a Finapres Nova® continuous BP monitoring device in correspondence with blood pressure monitoring devices standards. Researchers will test the device against the Finapres Nova® blood pressure monitoring device.

Detailed description

The purpose of this study is to evaluate a novel cuffless blood pressure monitoring device for clinical use. This device is a cuffless blood pressure watch worn on the wrist called BIO-Z. The device will be tested against the Finapres Nova® which is FDA-approved to capture continuous BP measurements. The participant will only need wear a wristband, potentially eliminating the need to perform cuff-based readings. During the 2-hour visit, research coordinators will conduct exercises to change BP and compare the values gathered by the BIO-Z watch with the Finapres Nova® device and a standard blood pressure cuff. The investigators will also test whether the Bio-Z can capture blood pressures that are in the low and high range, and whether motion affects the quality of measurement. The ultimate goal is to develop a device that passively collects blood pressure continuously, which is more convenient than a standard blood pressure cuff. 15 Participants will have the option to complete study procedures twice more, spaced one week apart, for a total of three weeks of participation.

Conditions

• Hypertension

Interventions

Type	Name	Description
DEVICE	BIO-Z	a novel cuffless continuous BP wrist monitor
DEVICE	Finapres Nova	a cuffless continuous BP monitor

Timeline

• Start date: 2023-01-11
• Primary completion: 2023-09-01
• Completion: 2023-09-01
• First posted: 2022-11-01
• Last updated: 2024-01-26

Locations

1 site across 1 country: United States