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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Mass General Brigham Hospital
  Boston, Massachusetts, United States Recruiting

Study contacts

• Study coordinator: Kristen Harriott
• Email: BWHWearableBP@mgb.org
• Phone: 617-525-8493

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.