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| Name | Class |
|---|---|
| Texas A&M University | OTHER |
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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:
Researchers will test the device against the Finapres Nova® blood pressure monitoring device.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BIO-Z vs. Finapres Nova | Experimental | Participants will have blood pressure in both arms measured three times using standard methods. The investigators will then fit the Bio-Z watch onto the non-dominant hand's wrist and the Finapres Nova® on the middle finger of the arm with the Bio-Z device. Participants will be asked to perform different exercises and blood pressure readings will be recorded during the exercise and recovery. Each exercise will be repeated three times. 15 Participants will have the option to complete study procedures twice more, spaced one week apart, for a total of three weeks of participation. Each visit will take at most 2 hours to complete study exercises for a total of 6 hours of study time if all the three visits are completed. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BIO-Z | Device | a novel cuffless continuous BP wrist monitor |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Mean absolute difference (MAD) value between Bio-Z wristband and Finapres Nova®. | MAD value between the BIO-Z BP readings and the FDA- approved Finapres Nova® readings collected during the study visit will be calculated. | during intervention, up to 2 hours |
| Mean absolute difference (MAD) value between Bio-Z wristband and Finapres Nova®. | 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. | up to 3 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Erica Spatz | Yale University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CSRU | New Haven | Connecticut | 06520 | United States |
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| ID | Term |
|---|---|
| D006973 | Hypertension |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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Each visit will take at most 2 hours to complete study exercises. 15 Participants will have the option to complete study procedures twice more, spaced one week apart, for a total of three weeks of participation.
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| Finapres Nova |
| Device |
a cuffless continuous BP monitor |
|