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

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.

Study Overview

• Status: Recruiting
• Conditions: Hypertension (HTN)
• Intervention / Treatment: Device: Aktiia G1 BP monitor for 12 months; Device: Traditional BP monitor for 6 months / Aktiia G1 BP monitor for 6 months

Detailed Description

This is a prospective open-label two-arm randomized clinical trial (RCT). The investigational device of this study is the Aktiia G1 BP monitor.

There is an active 6- month comparison period between two BP monitoring devices, followed by a 6-month follow-up period when all patients will have an Aktiia G1 BP monitor.

Each participant will be randomly assigned to one of two study groups: Group 1, or Group 2. The randomization will be a simple, based on a single computer-generated sequence of random assignments.

• Group 1: Aktiia G1 BP monitor (or "Hilo") - intervention 82 participants. These participants will receive an Aktiia G1 BP monitor and wear it through the entire 12-month study period.
• Group 2: Traditional BP monitor (upper arm cuff) - active control 82 participants. 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.

During the study, the patient completes online survey covering lifestyle, health, and socioeconomic environment.

• Study Type: Interventional
• Enrollment (Estimated): 164
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Kristen Harriott; Phone Number: 617-525-8493; Email: BWHWearableBP@mgb.org

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02115
      • Recruiting
      • Mass General Brigham Hospital
      • Contact: Kristen Harriott; Phone Number: 617-525-8493; Email: BWHWearableBP@mgb.org
      • Sub-Investigator: Dr. Naomi Fisher, MD
      • Sub-Investigator: Dr. Ezgi Guzelce, MD
      • Sub-Investigator: Dr. Ozan Unlu, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Adults aged 21 to 85 years.
• Able to read and speak English.
• Have an MGB provider and medical record number in EPIC
• Study participants will wear the Aktiia bracelet for 6 months
• Willing to attend two on-site study visits and comply with all study procedures.
• Signed informed consent provided.
• Own a smartphone with iOS or Android operating system.
• Hypertensive with uncontrolled systolic blood pressure (SBP) >135 mm Hg by unattended automated office measurement
• Currently taking 0, 1 or 2 antihypertensive medications.

Exclusion Criteria:

• Severe hypertension (SBP > 180 mmHg or DBP > 120 mmHg).
• Pregnant or breastfeeding.
• Known severe heart failure (LVEF < 35%).
• Known severe valvular heart disease.
• Known pheochromocytoma.
• Known severe chronic kidney disease (CKD stage 4-5; eGFR < 30 mL/min/1.73 m²).
• Known uncontrolled hyperthyroidism or hypothyroidism.
• Known severe diabetes (Hemoglobin A1c > 10%).
• Known resting heart rate > 120 bpm.
• Known persistent atrial fibrillation.
• Known Raynaud's disease.
• Known tremors or shivering disorders.
• Known exfoliative skin diseases.
• Known allergy to silicone.
• Presence of lymphedema.
• Paralysis of the arm.
• Arm amputation.
• Presence of implanted devices, such as a pacemaker, defibrillator, intravascular device, or arteriovenous fistula.
• Upper arm circumference < 22 cm or > 42 cm.
• Wrist circumference > 23 cm.
• Mastectomy

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	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.
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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in automated unattended office BP between the two groups from baseline to 6 months	Comparison of change in automated unattended office BP (average over triplicate consecutive measurements) from baseline to 6 months between the two groups: those given an Aktiia G1 BP monitor and those given a traditional upper arm BP cuff.	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of hypertensive subjects achieving BP control at 6 months in the intervention group compared to the standard treatment group	Percentage of hypertensive subjects achieving BP control at 6 months in the intervention group (Aktiia G1 BP monitor) compared to the standard treatment group (traditional upper arm cuff), defined by unattended automated office SBP <130 mm Hg.	6 months
Difference in patient engagement and lifestyle features between the 2 groups	To test if there is a difference in patient engagement and lifestyle features between the group given an Aktiia G1 BP monitor, and those given a traditional upper arm cuff, at baseline, 6 months and 12 months based on a questionnaire	0, 6 and 12 months
Difference in mean average Aktiia G1 BP measurement after a 6-month period	To compare the difference in mean average Aktiia G1 BP measurement between the first week and the last week of the six-month comparison period in the intervention group to the difference in mean Aktiia G1 BP measurement between the first and the last week of the follow-up period for the active control group.	6 months

Collaborators and Investigators

• Sponsor: Aktiia SA
• Collaborators: Massachusetts General Hospital; Brigham and Women's Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): April 1, 2026
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): December 1, 2027

Study Registration Dates

• First Submitted: March 30, 2026
• First Submitted That Met QC Criteria: April 8, 2026
• First Posted (Actual): April 13, 2026

Study Record Updates

• Last Update Posted (Actual): April 13, 2026
• Last Update Submitted That Met QC Criteria: April 8, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Vascular Diseases; Cardiovascular Diseases; Hypertension
• Additional Relevant MeSH Terms: Hypertension; Cardiovascular Diseases; Vascular Diseases
• Other Study ID Numbers: WEARABLE-BP

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No