Recruiting

Aktiia G1 vs. Cuff

Sponsor:

Aktiia SA

Code:

NCT07523269

Conditions

Hypertension (HTN)

Eligibility Criteria

Sex: All

Age: 21 - 70+

Healthy Volunteers: Not accepted

Interventions

Aktiia G1 BP monitor for 12 months

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

Study Details

Brief summary:

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.

Conditions

Hypertension (HTN)

Study ID

NCT07523269

Start date

Apr, 2026

Status verified date

Apr, 2026

Completion date

Dec, 2027

Anticipated

Primary completion date

Sep, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 21 - 70+

Healthy Volunteers: Not accepted

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 Design

Enrollment

164 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Other

Interventions and Outcome Measures

Arms

experimental: Group 1: Aktiia G1 BP monitor (or "Hilo") - intervention

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

active comparator: Group 2: Traditional BP monitor (upper arm cuff) - active control

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.

Interventions

Aktiia G1 BP monitor for 12 months

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

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 outcome measure

  • Change in automated unattended office BP between the two groups from baseline to 6 months [ Time Frame: 6 months ]

Central Contacts and Locations

Central contacts

Kristen Harriott

617-525-8493BWHWearableBP@mgb.org

Locations

Mass General Brigham Hospital

Recruiting

Boston, Massachusetts, United States, 02115

Contacts

Kristen Harriott

617-525-8493BWHWearableBP@mgb.org

More Information

Sponsor

Aktiia SA

Last update posted

Apr 13, 2026

Last verified

Apr, 2026

Keywords

  • Vascular Diseases
  • Cardiovascular Diseases
  • Hypertension

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Aktiia SA on 2026-04-13.