Early access
Sign in
Taking people in SwitzerlandNo phase

Wearable blood pressure device versus home cuff in people with hypertension

Compares a wearable blood pressure monitor with a home cuff in hypertension.

Key facts

Who runs it
Aktiia SA
Where
Geneva, Lausanne, and Sion, SwitzerlandSee the 3 sites
Trial code
Registry title
OBPM_Meds2023: Multicentric Prospective Clinical Study to Evaluate the Aktiia Optical Blood Pressure Monitoring (OBPM) Device Compared to Standard Home Blood Pressure Monitoring (HBPM) in Hypertensive Patients When Blood Pressure Lowering Medications Intake
Status
Recruiting
People taking part
35 people, planned
Started
29 Jun 2023
Expected to end
31 Dec 2026
Type of study
Interventional, 3 groups
Treatments tested
  • Aktiia Optical Blood Pressure Monitoring (OBPM) device and antihypertensive drugs (monotherapy and bitherapy)
  • Aktiia Optical Blood Pressure Monitoring (OBPM) device and antihypertensive drugs (monotherapy)
  • Aktiia Optical Blood Pressure Monitoring (OBPM) device and individualized antihypertensive treatment
Record updated
5 February 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults aged 21 to 85 with stage 1 or stage 2 high blood pressure, to compare the Aktiia wrist device with standard home blood pressure measurement while taking blood pressure medicine.

Age
21 to 85 years
Sex
All sexes
Disease stage
Hypertension stage 1 (SBP 140-159 mmHg or DBP 90-99 mmHg) or stage 2 (SBP 160-179 mmHg or DBP 100-109 mmHg). For people over 65, SBP of 160 mmHg or more.
Earlier treatment
No blood pressure medicine in the 3 months before Visit 1, and none during the study apart from the study drugs.

Main reasons for not taking part

  • Hypertension stage 3 (SBP/DBP above 180/110 mmHg)
  • Diabetes
  • Atrial fibrillation, or a pacemaker or defibrillator
  • Kidney problems (eGFR below 45 mL/min/1.73 m2)
  • Known pregnancy

The registry criteria, word for word

Show all 36 criteriaShow less

Who can take part

  • Adult subjects aged 21 to 85 years old
  • Subjects that can read and speak French
  • Subjects that own a smart phone that uses either the iOS or Android operating system
  • Hypertensive Stage 1 (SBP 140-159 mmHg or DBP 90-99 mmHg) or Hypertensive Stage 2 (SBP 160-179 mmHg or DBP 100-109 mmHg) or for subjects aged > 65yo SBP ≥160 mmHg,
  • Naive of antihypertensive drugs at the inclusion in the study (no antihypertensive drugs taken in the last 3 months before Visit 1) and during the conduct of the study apart from the study drugs
  • Subjects agreeing to attend all 4 on-site visits and follow study procedures
  • Subjects that have signed the informed consent form

Who cannot take part

  • Subjects have contraindications to the study drugs
  • Subjects who have received a mastectomy
  • Subjects with Hypertension Stage 3 (SBP/DBP >180/110 mmHg)
  • Subjects with tachycardia (heart rate at rest > 120bpm)
  • Severe valvular disease
  • Subjects with diabetes
  • Subjects with Raynaud's disease
  • Subjects with an arteriovenous fistula
  • Subjects with exfoliative skin diseases
  • For GROUPS 1 and 2 only: Subjects with target organ damage (left ventricular hypertrophy observed on ECG, and/ or, albumin/creatinine ratio in urine ≥3.5 mg/mmol)
  • Subjects with renal dysfunctions (eGFR < 45mL/min/1.73 m2 for patients between 21-85 yo)
  • Low or elevated potassium level: threshold ≤3.5 mmol/L or ≥4.8 mmol/L
  • Subjects with orthostatic hypotension (a 20 mmHg decrease in systolic BP, or 10 mmHg decrease in diastolic BP when measured in the standing position after a 1-minute waiting period)
  • Subjects who are likely to be unable to perform the HBPM required for the study within the designated time frame (7 to 11; a.m. and 4 to 9 p.m.)
  • Subjects having medical interventions or taking treatments during the study that could have an impact on their BP
  • Subjects with atrial fibrillation
  • Cardio myopathy (FE<40%)
  • Implanted devices such as a pacemaker or defibrillator
  • Subjects with hyper-/hypothyroidism
  • Subjects with pheochromocytoma
  • Women in known pregnancy
  • Subjects with trembling and shivering
  • Subjects with lymphoedema
  • Presence of an intravascular device
  • Subjects with arm paralysis
  • Subjects with arm amputation
  • Subjects with upper arm circumference < 22cm or > 42cm
  • Subjects with wrist circumference > 23cm
  • Subjects with non-standard circadian rhythm, including shift workers and night workers

Check if you might fit

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

  • Are you between 21 and 85 years old?

Where in Switzerland

  • HUGGeneva, SwitzerlandContact: Cléo Moulin, MasterNo longer taking part
  • CHUVLausanne, SwitzerlandContact: Grégoire Wuerzner, MD ProfTaking people
  • CHVRSion, SwitzerlandContact: Cléo Moulin, MasterNo longer taking part

About the trial

What the trial wants to find out

Study design: Prospective, multicentric, randomized, comparative study Study duration: between 4 and 19 weeks depending on the study group. Population: minimum 35 hypertensives (stage 1 or stage 2) participants divided into 3 groups depending on hypertension criteria. GROUP 1 = untreated hypertensives, stage 1 or stage 2; GROUP 2 = hypertensives, stage 1, who are taking antihypertensive monotherapy; GROUP 3 = hypertensives, stage 1 or stage 2, who are taking antihypertensive treatment that doesn't allow them to have controlled blood pressure.

Read full original descriptionShow less

Device Under Test (DUT): Aktiia device Reference: HBPM (Aktiia cuff) Periods of treatment: For GROUPS 1 and 2, 2 weeks of treatment for each antihypertensive medication followed by a washout period of 2 weeks (3 antihypertensive medications in total with a fixed dose; medication intake order is randomly assigned). For GROUP 3, an individualized new antihypertensive medication will be prescribed during the consultation with the investigator that will be administered for 3 weeks.

The 3 groups in the trial

  • Meds2023 GROUP 1Other group

    GROUP 1 participants are asked to wear the Aktiia bracelet continuously every day for 13 weeks in total and initialize their Aktiia bracelet with the Aktiia cuff at different timepoints. In parallel, GROUP 1 participants are asked to take 3 successive Blood Pressure lowering drugs during 2 weeks per treatment. Treatment periods are followed by 2 weeks of washout (no treatment).

    Treatment: Aktiia Optical Blood Pressure Monitoring (OBPM) device and antihypertensive drugs (monotherapy and bitherapy)

  • Meds2023 GROUP 2Other group

    GROUP 2 participants are asked to wear the Aktiia bracelet continuously every day for 19 weeks in total and initialize their Aktiia bracelet with the Aktiia cuff at different timepoints. In parallel, GROUP 2 participants are asked to stop their previous antihypertensive monotherapy for the first 2 weeks of the study participation and then take 3 successive blood pressure-lowering medications during 2 weeks per treatment. Treatment periods are followed by 2 weeks of washout (no treatment). Finally, they resume their initial monotherapy intake for a period of 4 weeks.

    Treatment: Aktiia Optical Blood Pressure Monitoring (OBPM) device and antihypertensive drugs (monotherapy)

  • Meds2023 GROUP 3Other group

    GROUP 3 participants are asked to wear the Aktiia bracelet continuously every day for 4 weeks in total and initialize their Aktiia bracelet with the Aktiia cuff at different timepoints. In parallel, GROUP 3 participants are asked to take their initial antihypertensive medication that doesn't allow them to have controlled blood pressure for 1 week. For the following 3 weeks of the study participation, GROUP 3 participants are asked to take an individualized antihypertensive therapy assigned by the investigator.

    Treatment: Aktiia Optical Blood Pressure Monitoring (OBPM) device and individualized antihypertensive treatment

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
Multicentric Prospective Clinical Study to Evaluate the Aktiia Optical Blood Pressure Monitoring (OBPM) Device Compared to Standard Home Blood Pressure Monitoring (HBPM) in Hypertensive Patients When Blood Pressure Lowering Medications Intake
Plain-language title
Wearable blood pressure device versus home cuff in people with hypertensionGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 12 November 2026.
Fit questions
Built from NCT05780710, who can take part
Record updated
5 February 2026