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

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Aktiia SA
Study ID
NCT07523269
Status
Recruiting
Apply to this trial

Conditions

  • Hypertension (HTN)

Eligibility Criteria

Sex
ALL
Age
21 Years - 85 Years
Healthy Volunteers
Not accepted

Interventions

  • Aktiia G1 BP monitor for 12 months — DEVICE
    These participants will receive an Aktiia G1 BP monitor and wear it through the entire 12-month study period.
  • Traditional BP monitor for 6 months / Aktiia G1 BP monitor for 6 months — DEVICE
    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.

Study Details

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.

Key Dates

Start date
Apr 30, 2026
Status verified
Apr 2026
Primary completion
Sep 30, 2027
Completion
Dec 31, 2027

Study Design

Enrollment
164 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER

Arms

  • Experimental: Group 1: Aktiia G1 BP monitor (or "Hilo") - intervention
    These participants will receive an Aktiia G1 BP monitor and wear it through the entire 12-month study period.
  • Active Comparator: Group 2: Traditional BP monitor (upper arm cuff) - active control
    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.

Primary Outcome Measure

Change in automated unattended office BP between the two groups from baseline to 6 months [ Time Frame: 6 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Mass General Brigham HospitalBostonMassachusetts02115
Kristen Harriott
[email protected]
617-525-8493
Dr. Naomi Fisher, MD (SUB_INVESTIGATOR)
Dr. Ezgi Guzelce, MD (SUB_INVESTIGATOR)
Dr. Ozan Unlu, MD (SUB_INVESTIGATOR)

Find similar trials in Boston, MA

By research site
Mass General Brigham Hospital· Boston, MA

Related Studies