WEARABLE-BP: Wearable Everyday Automated Readings to Enable Assessment of Blood Pressure Control

NCT07523269 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 164

Last updated 2026-04-13

No results posted yet for this study

Summary

The WEARABLE-BP study will evaluate the clinical value of obtaining continual measurements using the Aktiia G1 Optical Blood Pressure Monitoring (OBPM) device in hypertensive patients, compared to using a traditional upper arm cuff for home BP monitoring.

The WEARABLE-BP study aims to compare the change in unattended automated office blood pressure from baseline to 6 months between two study groups: those given an Aktiia G1 BP monitor and those given a traditional upper arm BP cuff.

Conditions

  • Hypertension (HTN)

Interventions

DEVICE

Aktiia G1 BP monitor for 12 months

These participants will receive an Aktiia G1 BP monitor and wear it through the entire 12-month study period.

DEVICE

Traditional BP monitor for 6 months / Aktiia G1 BP monitor for 6 months

These participants will receive a traditional BP monitor (validated upper arm cuff) to use for the 6 months comparison period. At the 6-month visit, they will return the traditional BP monitor and receive an Aktiia G1 BP monitor for the 6-month follow-up period.

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
21 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-04-30
Primary Completion
2027-09-30
Completion
2027-12-31
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

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 NCT07523269 on ClinicalTrials.gov