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

Hypertension Clinical Trial

Official title:

Cuff-less Wearable Blood Pressure Monitoring Device Validation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05601414
• Other study ID #: 2000032876
• Status: Completed
• Phase: N/A
• Start date: January 11, 2023
• Est. completion date: September 1, 2023

Study information

• Verified date: January 2024
• Source: Yale University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 41
• Est. completion date: September 1, 2023
• Est. primary completion date: September 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• Hypertensive volunteers who have a history of hypertension or a BP >140/90 mmHg on two consecutive ambulatory visits within the last year.

• Able to read, understand, and provide written informed consent in English

• Willing and able to participate in the study procedures as described in the consent form

• Able to communicate effectively with and follow instructions from the study staff

Exclusion Criteria:

• Persons with pacemakers and/or a non-sinus rhythm (A-fib)

• Persons who are taking 4 or more anti-hypertensive medications

• Persons on dialysis

• Persons who are unstable

• Persons with tremors

• Persons with known peripheral artery disease

• Persons with more than 10 mmHg differential blood pressure between right and left arm

• Persons taking medications that might affect the hypothalamic-pituitary-adrenal axis

• The investigators will exclude persons who are known to be pregnant after 20 weeks because of physiological changes in BP after 20 weeks of pregnancy; and will refer to Electronic Health Record data to determine pregnancy status at the time of screening. The investigators will not exclude participants of childbearing age or who become pregnant during the study since there are no risk of the devices to a pregnant person.

Related Conditions & MeSH terms

• Hypertension

Intervention

Device:
• BIO-Z
a novel cuffless continuous BP wrist monitor
• Finapres Nova
a cuffless continuous BP monitor

Locations

Country	Name	City	State
United States	CSRU	New Haven	Connecticut

Sponsors (2)

Lead Sponsor	Collaborator
Yale University	Texas A&M University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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