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

Aktiia SA · with Massachusetts General Hospital, Brigham and Women's Hospital · NCT07523269

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 21–85 · All sexes
Healthy volunteers
Not accepted (a condition is required)
Study type
Interventional · Not applicable
Target enrollment
164
US sites recruiting
1
Study start
April 2026
Record last updated
April 13, 2026

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the 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 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.

Being studied: Aktiia G1 BP monitor for 12 months; Traditional BP monitor for 6 months / Aktiia G1 BP monitor for 6 months

Conditions: Hypertension (HTN)

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full 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

Recruiting US locations

  • Mass General Brigham Hospital

    Boston, MA 02115

    Site contact: Kristen Harriott · 617-525-8493 · BWHWearableBP@mgb.org

Study contacts (from the official record)

  • Kristen Harriott · 617-525-8493 · BWHWearableBP@mgb.org
All heart & blood pressure studies in Massachusetts →
WEARABLE-BP: Wearable Everyday Automated Readings to Enable… (NCT07523269) | Bored Studies