The purpose of the proposed study is to test whether measuring unattended blood pressure using an automated blood pressure monitor in a clinic setting without staff being present can reduce the need for assessing out-of- clinic awake blood pressure using ambulatory monitoring. Also, the investigators will test whether asleep blood pressure can be accurately measured using a novel home blood pressure monitoring device with less burden compared with ambulatory monitoring.
For many people, blood pressure levels differ when measured in a doctor's office versus during normal daily activities. Ambulatory blood pressure monitoring, also called ABPM, involves wearing a blood pressure cuff attached to a device that is programmed to measure participants blood pressure every 30 minutes for a 24-hour period. ABPM can help better estimate a person's true average blood pressure. Although ABPM is recommended for diagnosing high blood pressure and it also measures blood pressure while people sleep, it is not available in many clinics and some people find the procedure to be uncomfortable. The purpose of this research study is to test whether blood pressure measured in a clinic setting without medical staff present is comparable to blood pressure levels measured during the daytime measured using an ABPM device. Also, the investigators will test whether asleep blood pressure can be accurately measured using a home blood pressure monitoring device. These findings may help identify new approaches for diagnosing high blood pressure without the need for ABPM. Each participant will complete four study visits. During the course of the study, participants will: * Have their blood pressure measured in the clinic, six times at each of the first two study visits for a total of twelve blood pressure measurements. * Complete questionnaires about their demographics, medical history, and participant sleeping habits. * Have their blood drawn and provide a urine sample. * Wear a Food and Drug Administration-approved ABPM device (Microlife WatchBP O3) for 24 hours. * Wear a Food and Drug Administration-approved home blood pressure monitor (Microlife WatchBP Home N) while they sleep for one night. * Wear an activity monitor (Actiwatch) for two 24-hour periods. The Actiwatch activity monitor measures activity levels and can be used to identify when they are asleep. * Answer some questions about their experience while wearing the ABPM and home blood pressure monitor. * Have an echocardiogram performed.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
654
Participants will have their blood pressure measured three times with an automated blood pressure monitor with a technician not present in the room.
Participants will have their blood pressure measured three times with an automated blood pressure monitor with a technician present in the room.
Participants will have their blood pressure measured every 30 minutes over 24-hours using an ambulatory blood pressure monitor.
University of Alabama at Birmingham Hypertension Research Clinic
Birmingham, Alabama, United States
Columbia University Medical Center - Hypertension Center
New York, New York, United States
Absolute Difference Between Unattended and Attended Blood Pressure
The difference between both systolic and diastolic blood pressure measurements when a technician is present versus when they are not present in the room.
Time frame: 2 days
Accuracy of Measuring Asleep Blood Pressure Using a Home Blood Pressure Monitor as Compared to Using an Ambulatory Blood Pressure Monitor
Participants will have their systolic and diastolic blood pressure measured overnight using a home blood pressure monitor and over 24-hours using an ambulatory blood pressure monitor.
Time frame: 2 days
Tolerability of Wearing a Home Blood Pressure Monitor Versus an Ambulatory Blood Pressure Monitor: Questionnaires
Participants will complete questionnaires regarding their experience wearing both the ambulatory and home blood pressure monitors as well as a questionnaire on their willingness to wear the devices again.
Time frame: 3 days
Left Ventricular Mass Index
Mean left ventricular mass index (LVMI)
Time frame: 3 days
Urinary Albumin-to-creatine Ratio
Mean urinary albumin-to-creatinine ratio (UACR)
Time frame: 3 days
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Participants will have their blood pressure measured three times overnight while they are asleep using a home blood pressure monitor.