Evaluating Novel Approaches for Estimating Awake and Sleep Blood Pressure

  • STATUS
    Recruiting
  • End date
    Mar 30, 2023
  • participants needed
    630
  • sponsor
    University of Alabama at Birmingham
Updated on 1 March 2022
Accepts healthy volunteers

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.

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.

Details
Condition Blood Pressure
Treatment Ambulatory blood pressure monitoring, Home Blood Pressure Monitoring, Unattended blood pressure measurement, Attended blood pressure measurement
Clinical Study IdentifierNCT04307004
SponsorUniversity of Alabama at Birmingham
Last Modified on1 March 2022

Eligibility

Yes No Not Sure

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
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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