Clinical trial NCT05601414: Blood Pressure Monitoring in Hypertensive Populations: Device Testing, Feasibility, Acceptability
Official title: Cuff-less Wearable Blood Pressure Monitoring Device Validation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypertension
Lead sponsor: Yale University
Sponsor class: OTHER
Collaborators: name: Texas A&M University
First posted: 2022-11-01
Enrollment: 41
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention 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.
Primary purpose: PREVENTION

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.

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.

Primary outcomes:
measure: Mean absolute difference (MAD) value between Bio-Z wristband and Finapres Nova®.
timeFrame: during intervention, up to 2 hours
measure: Mean absolute difference (MAD) value between Bio-Z wristband and Finapres Nova®.
timeFrame: up to 3 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: New Haven
country: United States
facility: CSRU
state: Connecticut
Study officials:
affiliation: Yale University
name: Erica Spatz
role: PRINCIPAL_INVESTIGATOR
References: