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WEARABLE-BP: Wearable Everyday Automated Readings to Enable Assessment of Blood Pressure Control
Who can join
Ages 21 to 85 · All sexes
Full eligibility criteria
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
About the study
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.
What is being tested
- Aktiia G1 BP monitor for 12 months (device)
- Traditional BP monitor for 6 months / Aktiia G1 BP monitor for 6 months (device)
Sponsor: Aktiia SA · Participants: 164 · Started: 2026-04
Contact the study team
- Kristen Harriott · Phone: 617-525-8493
Official record on ClinicalTrials.gov — NCT07523269
Locations in the U.S.
| Massachusetts | Mass General Brigham Hospital, Boston |
Conditions
From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.