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

NCT05601414 | Completed DMC

• 1 other identifier: 2000032876
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypertension

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (1)

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.

Device: BIO-Z; Device: Finapres Nova

Interventions

BIO-Z DEVICE

a novel cuffless continuous BP wrist monitor

BIO-Z vs. Finapres Nova

Finapres Nova DEVICE

a cuffless continuous BP monitor

BIO-Z vs. Finapres Nova

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Yale University: lead
• Texas A&M University: collaborator

Study Sites (1)

CSRU

New Haven, Connecticut, 06520, United States

Location

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Study Officials

• Erica Spatz

  Yale University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: October 26, 2022
• First Posted: November 1, 2022
• Study Start: January 11, 2023
• Primary Completion: September 1, 2023
• Study Completion: September 1, 2023
• Last Updated: January 26, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)