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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
21 Years to 85 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Procedures mentioned: Wearing a device, Questionnaires

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "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."
  • "During the study, the patient completes online survey covering lifestyle, health, and socioeconomic environment."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study compares the Aktiia G1 wearable blood pressure monitor with a standard upper arm cuff used at home. It is for adults with high blood pressure that is not controlled and will compare changes in office blood pressure readings over 6 months.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Age 21 to 85.
  • Able to read and speak English.
  • Have an MGB health care provider and an EPIC medical record number.
  • Willing to wear the Aktiia bracelet for 6 months.
  • Willing to attend 2 study visits in person, follow study steps, and sign a form agreeing to join.
  • Own an iPhone or Android smartphone.
  • Have uncontrolled high blood pressure, with a top number above 135 mm Hg on an automatic office reading taken without staff present.
  • Take 0, 1, or 2 medicines for high blood pressure.

Who can't join

  • Blood pressure with a top number above 180 or a bottom number above 120 mm Hg; resting heart rate above 120 beats per minute; or ongoing atrial fibrillation, a type of uneven heartbeat.
  • Severe heart failure with a pumping measure below 35%, severe heart valve disease, or severe kidney disease (stage 4–5, with a filtering measure below 30).
  • Pregnant or breastfeeding, or have had a mastectomy (surgery to remove a breast).
  • Pheochromocytoma (a hormone-making tumor), an uncontrolled overactive or underactive thyroid, or severe diabetes with an A1c blood sugar test above 10%.
  • Raynaud’s disease (reduced blood flow to fingers or toes), a disorder causing shaking or shivering, a disease causing peeling skin, or a silicone allergy.
  • Lymphedema (swelling from fluid buildup), an arm that is paralyzed, or an arm amputation.
  • An implanted device, such as a pacemaker, defibrillator, or device inside a blood vessel; or an arteriovenous fistula (a connection between an artery and a vein).
  • Upper arm measures less than 22 cm or more than 42 cm around, or wrist measures more than 23 cm around.

Simplified for readability. The official criteria below are what the study team uses.

Official 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

Study sites (1)

MA