Wearable Evaluation of Ambulatory Readings for Blood Pressure
Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 100
Healthy Volunteers: t
View:
• 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
Locations
United States
Massachusetts
Beth Israel Deaconess Medical Center
RECRUITING
Boston
Contact Information
Primary
Stephen P. Juraschek, MD, PhD
sjurasch@bidmc.harvard.edu
617-754-1416
Backup
Fredrick Larbi Kwapong, MD, MPH
flarbikw@bidmc.harvard.edu
781-975-4920
Time Frame
Start Date: 2025-06-06
Estimated Completion Date: 2026-06-30
Participants
Target number of participants: 100
Treatments
Experimental: Cuff-based ambulatory blood pressure monitor sequence
Participants will be randomized 1:1 to wear (A) the Spacelabs ambulatory blood pressure monitor on the first day and ABPMPro ambulatory blood pressure monitor on the second day or (B) ABPMPro ambulatory blood pressure monitor on the first day then Spacelabs ambulatory blood pressure monitor on the second day.
Experimental: Left versus right upper limb
Participants will be randomized to wear the Aktiia cuffless blood pressure device on either the left upper limb versus the right upper limb on the first day. On the second day, the Aktiia blood pressure device will be switched to the other arm which did not get randomized on the first day. Another wristband (LiveMetric versus Bpro) will be worn on the contralateral arm.
Experimental: Wristband sequence (first day versus second day)
Participants will be randomized 1:1 to wear (A) the LiveMetric wristband on the first day and Bpro wristband on the second day or (B) Bpro wristband on the first day then LiveMetric wristband on the second day. The arm side (i.e., right or left) will be determined by the Aktiia cuffless blood pressure device randomization on the first day. For the second day, the Aktiia cuffless blood pressure device will be worn on the arm opposite the first day with the other device (LiveMetric versus Bpro) worn on the contralateral arm.
Related Therapeutic Areas
Sponsors
Leads: Stephen Juraschek
Collaborators: National Institutes of Health (NIH), National Heart, Lung, and Blood Institute (NHLBI)