NCT07523269 · Aktiia SA
WEARABLE-BP: Wearable Everyday Automated Readings to Enable Assessment of Blood Pressure Control
(WEARABLE-BP)
What this study is about
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 treatment group$1 cuff for home BP monitoring.
View original scientific description
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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.
Where
- Boston, Massachusetts
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Apr 13, 2026 · Source of record for eligibility and locations