CSRU
New Haven, Connecticut, 06520, United States
NCT Number: NCT05601414
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.
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Notify Me18 year–75 year
All sexes
Interventional
Not applicable
New Haven, Connecticut, 06520, United States
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
a novel cuffless continuous BP wrist monitor
a cuffless continuous BP monitor
Time frame: during intervention, up to 2 hours
MAD value between the BIO-Z BP readings and the FDA- approved Finapres Nova® readings collected during the study visit will be calculated.
Time frame: up to 3 weeks
MAD value between the BIO-Z BP readings and the FDA- approved Finapres Nova® readings collected during the study visit will be calculated from the sub set of 15 participants.
Yale University
Other
Cuff-less Wearable Blood Pressure Monitoring Device Validation
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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