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NCT Number: NCT07523269

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

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.

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Key information

Conditions

Hypertension (HTN) Cardiovascular Diseases Hypertension Vascular Diseases

Age range

21 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mass General Brigham Hospital

Boston, Massachusetts, 02115, United States

Location status: Recruiting

Location contact

Dr. Ezgi Guzelce, MD

SUB_INVESTIGATOR

Dr. Naomi Fisher, MD

SUB_INVESTIGATOR

Dr. Ozan Unlu, MD

SUB_INVESTIGATOR

Kristen Harriott

CONTACT

[email protected]

617-525-8493

About this study

This is a prospective open-label two-arm randomized clinical trial (RCT). The investigational device of this study is the Aktiia G1 BP monitor.

There is an active 6- month comparison period between two BP monitoring devices, followed by a 6-month follow-up period when all patients will have an Aktiia G1 BP monitor.

Each participant will be randomly assigned to one of two study groups: Group 1, or Group 2. The randomization will be a simple, based on a single computer-generated sequence of random assignments.

  • Group 1: Aktiia G1 BP monitor (or "Hilo") - intervention 82 participants. These participants will receive an Aktiia G1 BP monitor and wear it through the entire 12-month study period.
  • Group 2: Traditional BP monitor (upper arm cuff) - active control 82 participants. These participants will receive a traditional BP monitor (validated upper arm cuff) to use for the 6 months comparison period. At the 6-month visit, they will return the traditional BP monitor and receive an Aktiia G1 BP monitor for the 6-month follow-up period.

During the study, the patient completes online survey covering lifestyle, health, and socioeconomic environment.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Aktiia G1 BP monitor for 12 months

Device

These participants will receive an Aktiia G1 BP monitor and wear it through the entire 12-month study period.

Traditional BP monitor for 6 months / Aktiia G1 BP monitor for 6 months

Device

These participants will receive a traditional BP monitor (validated upper arm cuff) to use for the 6 months comparison period. At the 6-month visit, they will return the traditional BP monitor and receive an Aktiia G1 BP monitor for the 6-month follow-up period.

Primary outcomes

  1. Change in automated unattended office BP between the two groups from baseline to 6 months

    Time frame: 6 months

    Comparison of change in automated unattended office BP (average over triplicate consecutive measurements) from baseline to 6 months between the two groups: those given an Aktiia G1 BP monitor and those given a traditional upper arm BP cuff.

Secondary outcomes

  1. Percentage of hypertensive subjects achieving BP control at 6 months in the intervention group compared to the standard treatment group

    Time frame: 6 months

    Percentage of hypertensive subjects achieving BP control at 6 months in the intervention group (Aktiia G1 BP monitor) compared to the standard treatment group (traditional upper arm cuff), defined by unattended automated office SBP <130 mm Hg.

  2. Difference in patient engagement and lifestyle features between the 2 groups

    Time frame: 0, 6 and 12 months

    To test if there is a difference in patient engagement and lifestyle features between the group given an Aktiia G1 BP monitor, and those given a traditional upper arm cuff, at baseline, 6 months and 12 months based on a questionnaire

  3. Difference in mean average Aktiia G1 BP measurement after a 6-month period

    Time frame: 6 months

    To compare the difference in mean average Aktiia G1 BP measurement between the first week and the last week of the six-month comparison period in the intervention group to the difference in mean Aktiia G1 BP measurement between the first and the last week of the follow-up period for the active control group.

Study contacts

Contact information is provided by the study sponsor or research team.

Kristen Harriott

CONTACT

[email protected]

617-525-8493

Sponsors and collaborators

Lead sponsor

Aktiia SA

Industry

Collaborators

  • Brigham and Women's Hospital
  • Massachusetts General Hospital

Registry information

Acronym: WEARABLE-BP

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Apr 13, 2026
Registry last updated
Apr 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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