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

NCT ID: NCT05601414

Last Updated: 2024-01-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 41 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-01-11
• Study Completion Date: 2023-09-01

Brief 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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

BIO-Z vs. Finapres Nova

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.

Group Type: EXPERIMENTAL

BIO-Z

Intervention Type: DEVICE

a novel cuffless continuous BP wrist monitor

Finapres Nova

Intervention Type: DEVICE

a cuffless continuous BP monitor

Interventions

BIO-Z

a novel cuffless continuous BP wrist monitor

Intervention Type: DEVICE

Finapres Nova

a cuffless continuous BP monitor

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Texas A&M University

OTHER

Sponsor Role: collaborator

Yale University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Erica Spatz

Role: PRINCIPAL_INVESTIGATOR

Yale University

Locations

CSRU

New Haven, Connecticut, United States

Countries

United States

Other Identifiers

2000032876

Identifier Type: -

Identifier Source: org_study_id