Evaluating Novel Approaches for Estimating Awake and Sleep Blood Pressure
Evaluating Novel Approaches for Estimating Awake and Sleep Blood Pressure
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.
Inclusion Criteria:

 -  Mean screening systolic blood pressure of 110 to < 160 mm Hg at most recent visit

 -  Mean screening diastolic blood pressure of 70 to <100 mm Hg at most recent visit

 Exclusion Criteria:

 -  Currently taking antihypertensive medications

 -  Known to be currently pregnant

 -  History of sleep apnea

 -  History of heart attack, stroke, or any cardiovascular disease

 -  History of arrhythmia (e.g. - atrial fibrillation or ventricular tachycardia)

 -  Completed ambulatory blood pressure monitoring in the past year

 -  Second shift, overnight, or jobs that will not allow ambulatory blood pressure device
 to measure every 30 minutes for 24 hours.