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NCT Number: NCT04307004

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.

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Key information

Conditions

Age range

19 year–87 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Alabama at Birmingham Hypertension Research Clinic, Birmingham, Alabama, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Unattended blood pressure measurement

Other

Participants will have their blood pressure measured three times with an automated blood pressure monitor with a technician not present in the room.

Other names: Microlife WatchBP Office AFIB

Attended blood pressure measurement

Other

Participants will have their blood pressure measured three times with an automated blood pressure monitor with a technician present in the room.

Other names: Microlife WatchBP Office AFIB

Ambulatory blood pressure monitoring

Other

Participants will have their blood pressure measured every 30 minutes over 24-hours using an ambulatory blood pressure monitor.

Other names: Microlife WatchBP O3

Home blood pressure monitoring

Other

Participants will have their blood pressure measured three times overnight while they are asleep using a home blood pressure monitor.

Other names: Microlife WatchBP Home N

Primary outcomes

  1. Absolute Difference Between Unattended and Attended Blood Pressure

    Time frame: 2 days

    The difference between both systolic and diastolic blood pressure measurements when a technician is present versus when they are not present in the room.

  2. Accuracy of Measuring Asleep Blood Pressure Using a Home Blood Pressure Monitor as Compared to Using an Ambulatory Blood Pressure Monitor

    Time frame: 2 days

    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.

  3. Tolerability of Wearing a Home Blood Pressure Monitor Versus an Ambulatory Blood Pressure Monitor: Questionnaires

    Time frame: 3 days

    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.

Secondary outcomes

  1. Left Ventricular Mass Index

    Time frame: 3 days

    Mean left ventricular mass index (LVMI)

  2. Urinary Albumin-to-creatine Ratio

    Time frame: 3 days

    Mean urinary albumin-to-creatinine ratio (UACR)

Sponsors and collaborators

Lead sponsor

University of Alabama at Birmingham

Other

Collaborators

  • Columbia University
  • National Heart, Lung, and Blood Institute (NHLBI)

Registry information

Official study title

Evaluating Novel Approaches for Estimating Awake and Sleep Blood Pressure - Better BP Study

Important dates

Study start
2019
Primary completion
2022
Study completion
2022
First posted
Mar 13, 2020
Registry last updated
Dec 13, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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