Aktiia G1 BP monitor for 12 monthsTraditional BP monitor for 6 months / Aktiia G1 BP monitor for 6 months
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.
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.
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.
Eligibility
Sex
ALL
Min age
21 Years
Max age
85 Years
Healthy volunteers
No
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
Primary outcome measure(s)
Change in automated unattended office BP between the two groups from baseline to 6 months — 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.
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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