Comparing a wearable optical blood pressure band with a traditional upper‑arm cuff for people with high blood pressure

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

This study will test whether using the Aktiia G1 wearable blood pressure monitor helps people with high blood pressure control their blood pressure better than a traditional upper‑arm cuff.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 164 (estimated)
• Ages: 21 Years to 85 Years
• Sex: All
• Sponsor: Aktiia SA (industry)
• Locations: 1 site (Boston, Massachusetts)
• Trial ID: NCT07523269 on ClinicalTrials.gov

What this trial studies

This is a prospective, open‑label, two‑arm randomized trial enrolling about 164 adults with uncontrolled hypertension. Participants are randomly assigned to wear an Aktiia G1 optical wrist monitor for 12 months or to use a validated upper‑arm cuff for the first 6 months and then switch to the Aktiia device for the final 6 months. The primary comparison is change in unattended automated office systolic blood pressure from baseline to 6 months, with additional data collected from device measurements and online lifestyle and health surveys. The trial is sponsored by Aktiia SA in collaboration with Mass General Brigham and conducted at Mass General Brigham sites in Boston.

Who should consider this trial

Good fit: Adults 21–85 years old with uncontrolled systolic hypertension (>135 mmHg by unattended automated office measurement), on 0–2 antihypertensive medications, who own a smartphone, can read English, have an MGB provider/EPIC record, and can attend two on‑site visits are ideal candidates.

Not a fit: People with severe hypertension (SBP >180 mmHg or DBP >120 mmHg), severe heart failure, advanced CKD, pregnancy, very high resting heart rate, or those without a smartphone or access to the Mass General Brigham system are unlikely to benefit from this study.

Why it matters

Potential benefit: If successful, continuous wearable BP monitoring could make it easier to detect and manage uncontrolled blood pressure and improve overall BP control outside the clinic.

How similar studies have performed: Previous observational and short‑term studies of cuffless and wearable BP technologies have produced mixed results, and randomized comparisons of continuous optical monitors versus standard cuffs remain limited.

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

Where this trial is running

Boston, Massachusetts

• Mass General Brigham Hospital — Boston, Massachusetts, United States (RECRUITING)

Study contacts

• Study coordinator: Kristen Harriott

Conditions: Hypertension, Vascular Diseases, Cardiovascular Diseases