Ignite Creation Date:
2025-12-24 @ 8:03 PM
Ignite Modification Date:
2025-12-25 @ 5:36 PM
Study NCT ID:
NCT04307004
Status:
COMPLETED
Last Update Posted:
2024-12-13
First Post:
2020-03-02
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Evaluating Novel Approaches for Estimating Awake and Sleep Blood Pressure
Sponsor:
University of Alabama at Birmingham
Organization:
Study Overview
Official Title:
Evaluating Novel Approaches for Estimating Awake and Sleep Blood Pressure - Better BP Study
Status:
COMPLETED
Status Verified Date:
2024-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
* 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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| R01HL139716 | NIH | None | https://reporter.nih.gov/quic… | View |