Blood Pressure Monitoring in Hypertensive Populations: Device Testing, Feasibility, Acceptability
Completed · Not applicable
Conditions studied: Hypertension
In brief
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.
Key facts
- Study ID
- NCT05601414
- Run by
- Yale University
- People needed
- 41
- Starts
- 2023-01-11
- Expected to finish
- 2023-09-01
- Last updated by the study team
- 2024-01-26
Who can join
Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.
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.
Where it is running
- CSRU — New Haven, Connecticut, United States
Full record on ClinicalTrials.gov
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