Clinical trial NCT06610448: Wearable Evaluation of Ambulatory Readings for Blood Pressure
Official title: Wearable Evaluation of Ambulatory Readings for Blood Pressure
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Normal Blood Pressure
Controlled Hypertension
Uncontrolled Hypertension
Keywords: Cuff-based BP device
Cuffless BP device
ABPM
Blood Pressure
Hypertension
Lead sponsor: Beth Israel Deaconess Medical Center
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2024-09-24
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Each participant is randomly assigned a different blood pressure device each day over the course of 3 days. All participants will use each device, but the devices will be applied on different days and on different arms.
Primary purpose: OTHER

Brief summary: The purpose of this project is to compare the performance and validity of novel wearable technologies that measure blood pressure (BP) and physical activity with a Spacelabs Ambulatory Blood Pressure Monitoring (ABPM) device.

Detailed description: The investigators will recruit community-dwelling participants to wear novel cuffless BP monitoring devices for comparison with a Spacelabs ABPM device throughout a 24-hour period. The identification of accurate cuffless BP technologies would greatly improve access to ABPM and allow for BP measurements at times when the use of cuff-based devices are not feasible. Knowledge from this project will inform subsequent research protocols among adults and under-represented groups.

Up to 250 participants (at least 100) will be involved in this study each wearing up to 7 devices (6 BP devices and 1 activity monitor). The assignment of devices will be randomized by day and by the arm or wrist on which they are worn. During the first visit, participants will provide their consent and be randomly fitted with 3 BP devices; either the Spacelabs ABPM device or the ABPMpro device, the Aktiia wristband BP monitor, and one of two other cuff-based wrist BP monitors, along with an activity monitor to track body positions. These devices will be worn continuously for at least 24-hours, including overnight, before being returned. On the following day, for Visit 2, participants will be fitted with a different set of 3 BP devices; the ABPMpro device or Spacelabs ABPM device, the Aktiia wristband BP device (on the opposite wrist from the previous day), and the final cuff-based wristband BP device. Additionally, participants will wear an ambulatory BP device as a patch on the chest. These devices will also be worn for at least 24 hours. This study will enable characterization of the feasibility, practicality, and effectiveness of the measurements and the devices\&#39; accuracy and precision.

Eligibility criteria: Inclusion Criteria:

* Age 18 to 100 years
* All neighborhoods in Boston area
* Be able to walk with two limbs and have two arms
* Willing and able to complete required measurement procedures
* Able to provide informed consent

Exclusion Criteria:

* Failure to receive informed consent
* Arm circumference of more than 50cm

Primary outcomes:
measure: Systolic Blood Pressure
timeFrame: 24 - 48 hours
Secondary outcomes:
measure: Diastolic Blood Pressure
timeFrame: 24 - 48 hours
measure: Heart Rate
timeFrame: 24 - 48 hours
measure: ActivPaL device (Physical activity monitor)
timeFrame: 24 - 48 hours
Other outcomes:
measure: Systolic blood pressure from the Biobeat device (Chest Patch Blood Pressure device)
timeFrame: 24 hours
Locations:
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center
state: Massachusetts
Study officials:
References: