← Back to all trials
Recruiting
NCT05601414
Blood Pressure Monitoring in Hypertensive Populations: Device Testing, Feasibility, Acceptability
Conditions: Hypertension
Sex: All
Ages: 18 Years – 75 Years
Phase: NA
Enrollment: 40
Sponsor: Yale University
Location: United States
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.
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 EnglishWilling and able to participate in the study procedures as described in the consent formAble to communicate effectively with and follow instructions from the study staffExclusion Criteria:Persons who are taking 4 or more antihypertensive medicationsPersons on dialysisPersons who are unstablePersons with tremorsPersons with known peripheral artery diseasePersons with more than 10 mmHg differential blood pressure between right and left armPersons taking medications that might affect the hypothalamic-pituitary-adrenal axisWe will exclude persons who are known to be pregnant after 20 weeks because of physiological changes in BP after 20 weeks of pregnancy; we will refer to Electronic Health Record data to determine pregnancy status at the time of screening.
We 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.
Source: ClinicalTrials.gov (NCT05601414). StuddyBuddy aggregates publicly available trial information.