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Evaluating Novel Approaches for Estimating Awake and Sleep Blood Pressure

NCT04307004 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 654

Last updated 2024-12-13

Study results available
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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.

Conditions

  • Blood Pressure

Interventions

OTHER

Unattended blood pressure measurement

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

OTHER

Attended blood pressure measurement

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

OTHER

Ambulatory blood pressure monitoring

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

OTHER

Home blood pressure monitoring

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

Sponsors & Collaborators

  • Columbia University

    collaborator OTHER

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

    collaborator NIH

  • University of Alabama at Birmingham

    lead OTHER

Principal Investigators

  • Paul Muntner, PhD · University of Alabama at Birmingham

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
19 Years
Max Age
87 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-07-15
Primary Completion
2022-12-12
Completion
2022-12-13

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04307004 on ClinicalTrials.gov