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

Back to results

Primary Purpose

Status

Recruiting

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

BIO-Z

Finapres Nova

About this trial

This is an interventional prevention trial for Hypertension

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

CSRURecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

BIO-Z vs. Finapres Nova

Arm Description

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.

Outcomes

Primary Outcome Measures

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.

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.

Secondary Outcome Measures

Full Information

NCT ID

NCT05601414

First Posted

October 26, 2022

Last Updated

April 4, 2023

Sponsor

Yale University

Collaborators

Texas A&M Engineering Experiment Station

1. Study Identification

Unique Protocol Identification Number

NCT05601414

Brief Title

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

Official Title

Cuff-less Wearable Blood Pressure Monitoring Device Validation

Study Type

Interventional

2. Study Status

Record Verification Date

April 2023

Overall Recruitment Status

Recruiting

Study Start Date

January 11, 2023 (Actual)

Primary Completion Date

December 2023 (Anticipated)

Study Completion Date

December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Yale University

Collaborators

Texas A&M Engineering Experiment Station

4. Oversight

Studies a U.S. FDA-regulated Drug Product

No

Studies a U.S. FDA-regulated Device Product

No

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hypertension

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Model Description

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.

Masking

None (Open Label)

Allocation

N/A

Enrollment

40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

BIO-Z vs. Finapres Nova

Arm Type

Experimental

Arm Description

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.

Intervention Type

Device

Intervention Name(s)

BIO-Z

Intervention Description

a novel cuffless continuous BP wrist monitor

Intervention Type

Device

Intervention Name(s)

Finapres Nova

Intervention Description

a cuffless continuous BP monitor

Primary Outcome Measure Information:

Title

Mean absolute difference (MAD) value between Bio-Z wristband and Finapres Nova®.

Description

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

during intervention, up to 2 hours

Title

Mean absolute difference (MAD) value between Bio-Z wristband and Finapres Nova®.

Description

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.

Time Frame

up to 3 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

No

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Erica Spatz, MD

Phone

203-785-6012

Email

ERICA.SPATZ@YALE.EDU

First Name & Middle Initial & Last Name or Official Title & Degree

Harlan Krumholz, MD, SM

Email

HARLAN.KRUMHOLZ@YALE.EDU

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Erica Spatz

Organizational Affiliation

Yale University

Official's Role

Principal Investigator

Facility Information:

Facility Name

CSRU

City

New Haven

State/Province

Connecticut

ZIP/Postal Code

06520

Country

United States

Individual Site Status

Recruiting

12. IPD Sharing Statement

Plan to Share IPD

No

Hypertension

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial