Evaluating Novel Approaches for Estimating Awake and Sleep Blood Pressure
Condition: Blood Pressure
Study type: Interventional

Summary: 
      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.
    

Detailed description: 
      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.
    

Intervention name(s): Unattended blood pressure measurement; Attended blood pressure measurement; Ambulatory blood pressure monitoring; Home blood pressure monitoring
Intervention type(s): Other; Other; Other; Other
Intervention description(s): 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.; Participants will have their blood pressure measured three times overnight while they are asleep using a home blood pressure monitor.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: Ambulatory blood pressure monitoring; Home blood pressure monitoring; Clinic blood pressure; Blood pressure phenotypes