HypertensionOBPM_Meds2023NCT05780710
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
A study testing Aktiia Optical Blood Pressure Monitoring (OBPM) device and antihypertensive drugs (monotherapy and bitherapy), Aktiia Optical Blood Pressure Monitoring (OBPM) device and antihypertensive drugs (monotherapy) and Aktiia Optical Blood Pressure Monitoring (OBPM) device and individualized antihypertensive treatment in people with Hypertension, run by Aktiia SA at 3 sites in Switzerland.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 21 to 85 years
- Conditions the study is for
- Hypertension
- What is being 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) and Aktiia Optical Blood Pressure Monitoring (OBPM) device and individualized antihypertensive treatment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 3 sitesSwitzerland
- Study dates
- 29 Jun 2023to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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 join
- Subjects have contraindications to the study drugs
- Subjects with Hypertension Stage 3 (SBP/DBP >180/110 mmHg)
- 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
Show all 30Show fewer
- 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 tachycardia (heart rate at rest > 120bpm)
- Subjects with atrial fibrillation
- Cardio myopathy (FE<40%)
- Severe valvular disease
- Implanted devices such as a pacemaker or defibrillator
- Subjects with diabetes
- Subjects with renal dysfunctions (eGFR < 45mL/min/1.73 m2 for patients between 21-85 yo)
- Subjects with hyper-/hypothyroidism
- Subjects with pheochromocytoma
- Subjects with Raynaud's disease
- Subjects with an arteriovenous fistula
- Women in known pregnancy
- Subjects with trembling and shivering
- Subjects with lymphoedema
- Low or elevated potassium level: threshold ≤3.5 mmol/L or ≥4.8 mmol/L
- Presence of an intravascular device
- Subjects with exfoliative skin diseases
- 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
- Subjects who have received a mastectomy.
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Pascale Vermare, Master contact
Switzerland3 sites, 1 recruiting
- Terminated
HUG
Geneva, Canton of Geneva, 1205
- Recruiting
CHUV
Lausanne, 1011
Grégoire Wuerzner, MD Prof, +41213141131, gregoire.wuerzner@chuv.ch
- Withdrawn
CHVR
Sion, Valais, 1951
About this study
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
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.
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.
Read the detailed description
This study with N = 35 participants minimum, over 2 to 6 visits, depending on the study group, has been designed to compare Aktiia device systolic and diastolic blood pressure measurements against HBPM reference measurements in participants taking 3 successive BP-lowering medications during 2 weeks per treatment for GROUPS 1 and 2, while GROUP 3 will receive, during 3 weeks, an individualized medication decided by the investigator. For GROUPS 1 and 2, periods of treatment are followed by 2 weeks of washout.
Study participants are: For GROUP 1, 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) that are naive of antihypertensive treatments at the inclusion in the study. For GROUP 2, hypertensives Stage 1 (SBP 140-159 mmHg or DBP 90-99 mmHg) with no other cardiovascular risk factors who are taking an antihypertensive monotherapy, for whom previous treatment will be stopped at the study inclusion and will be resumed for the last 4 weeks of the study participation. For GROUP 3, uncontrolled 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) who are taking antihypertensive treatment that doesn't allow them to have controlled blood pressure.
Study participants are asked to:
Wear the Aktiia bracelet continuously every day for 4 to 19 weeks in total, depending on the study group, Initialize their bracelet with the Aktiia cuff at different time points, Measure their blood pressure with an HBPM (Aktiia cuff) twice per day, Take their BP-lowering medications during the treatment periods, Complete 2 to 3 different surveys, depending on the study group, to give their feedback on Aktiia product use compared to HBPM.
- Conditions
- Hypertension
- Being 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
- Keywords
- Hypertension, Blood Pressure
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aktiia Optical Blood Pressure Monitoring (OBPM) device and antihypertensive drugs (monotherapy and bitherapy)Other
Also called Aktiia system, Aktiia device, Aktiia bracelet, Aktiia cuff
The device under test is Aktiia Optical Blood Pressure Monitoring (OBPM) device and the comparator is the Aktiia cuff.
For study GROUP 1:
Study drugs are:
- Perindopril MEPHA (Angiotensin Converting Enzyme (ACE) inhibitors).
- Indapamide MEPHA (Diuretics).
- Amlodipine MEPHA (Calcium channel blockers). In each study treatment period, subjects in GROUP 1 will receive one of the following for each treatment period: monotherapy with Indapamide, bitherapy with Indapamide plus Perindopril, or bitherapy with Perindopril plus Amlodipine.
Aktiia Optical Blood Pressure Monitoring (OBPM) device and antihypertensive drugs (monotherapy)Other
Also called Aktiia system, Aktiia device, Aktiia bracelet, Aktiia cuff
Study drugs:
- Perindopril MEPHA (Angiotensin Converting Enzyme (ACE) inhibitors).
- Indapamide MEPHA (Diuretics).
- Amlodipine MEPHA (Calcium channel blockers). In each study treatment period, subjects in GROUP 2 will receive one of the following monotherapies: Perindopril , Indapamide, or Amlodipine.
Aktiia Optical Blood Pressure Monitoring (OBPM) device and individualized antihypertensive treatmentOther
Also called Aktiia system, Aktiia device, Aktiia bracelet, Aktiia cuff
For study GROUP 3:
Subjects will be prescribed an individualized new antihypertensive treatment at their consultation with the Investigator at Visit 1.
| Study group | Role | What they receive |
|---|---|---|
| Meds2023 GROUP 1 | Other | 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). Receives: Other: Aktiia Optical Blood Pressure Monitoring (OBPM) device and antihypertensive drugs (monotherapy and bitherapy) |
| Meds2023 GROUP 2 | Other | 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. Receives: Other: Aktiia Optical Blood Pressure Monitoring (OBPM) device and antihypertensive drugs (monotherapy) |
| Meds2023 GROUP 3 | Other | 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. Receives: Other: Aktiia Optical Blood Pressure Monitoring (OBPM) device and individualized antihypertensive treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Daytime Systolic and Diastolic Blood Pressure averages (last 3 days of week 1 versus last 3 days of week 3)
Statistics on the comparison of the changes in average daytime Blood Pressure values pre- and post-intervention between the two modalities (Aktiia device and HBPM)
Measured: Last 3 days of the washout period (week 1), against the last 3 days of the treatment period (week 3)
Daytime Systolic and Diastolic Blood Pressure averages (last 3 days of week 5 versus last 3 days of week 7)
Statistics on the comparison of the changes in average daytime Blood Pressure values pre- and post-intervention between the two modalities (Aktiia device and HBPM)
Measured: Last 3 days of the washout period (week 5), against the last 3 days of the treatment period (week 7)
Daytime Systolic and Diastolic Blood Pressure averages (last 3 days of week 9 versus last 3 days of week 11)
Statistics on the comparison of the changes in average daytime Blood Pressure values pre- and post-intervention between the two modalities (Aktiia device and HBPM)
Measured: Last 3 days of the washout period (week 9), against the last 3 days of the treatment period (week 11)
Secondary outcomes (3)
Participant's compliance
Number of measurements made each day by the Aktiia System
Measured: GROUP 1= 13 weeks; GROUP 2= 19 weeks; GROUP 3= 4 weeks.
Participant's compliance
Number of successful synchronizations with the Aktiia System
Measured: GROUP 1= 13 weeks; GROUP 2= 19 weeks; GROUP 3= 4 weeks.
Participant's perception
Compilation of answers to the surveys
Measured: GROUP 1= 13 weeks; GROUP 2= 19 weeks; GROUP 3= 4 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2023
- Study start29 Jun 2023
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypertensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Study participants are asked to wear the Aktiia bracelet continuously every day for 4 to 19 weeks in total, depending on the study group, and initialize their Aktiia bracelet with the Aktiia cuff at different timepoints. In parallel, GROUP 1 and 2 participants are asked to take 3 successive Blood Pressure lowering medications during 2 weeks per treatment. Treatment periods are followed by 2 weeks of washout. The order of drug intake is randomly assigned for every participant. GROUP 3 participants will receive and individualized antihypertensive medication assigned by the investigator.
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 35 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aktiia SA
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05780710
- Sponsor's protocol ID
- OBPM_Meds2023
- Acronym
- OBPM_Meds2023
- Status last verified
- Feb 2026
- First submitted
- 10 Feb 2023
- Last updated
- 5 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05780710
- Acronym / sponsor ID
- OBPM_Meds2023 / OBPM_Meds2023
- Conditions
- Hypertension
- Keywords
- Hypertension, Blood Pressure
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 35 participants (estimated)
- Lead sponsor
- Aktiia SAIndustry (pharma, biotech, devices)
- Study start
- 29 Jun 2023 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 22 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Detailed description
This study with N = 35 participants minimum, over 2 to 6 visits, depending on the study group, has been designed to compare Aktiia device systolic and diastolic blood pressure measurements against HBPM reference measurements in participants taking 3 successive BP-lowering medications during 2 weeks per treatment for GROUPS 1 and 2, while GROUP 3 will receive, during 3 weeks, an individualized medication decided by the investigator. For GROUPS 1 and 2, periods of treatment are followed by 2 weeks of washout.
Study participants are: For GROUP 1, 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) that are naive of antihypertensive treatments at the inclusion in the study. For GROUP 2, hypertensives Stage 1 (SBP 140-159 mmHg or DBP 90-99 mmHg) with no other cardiovascular risk factors who are taking an antihypertensive monotherapy, for whom previous treatment will be stopped at the study inclusion and will be resumed for the last 4 weeks of the study participation. For GROUP 3, uncontrolled 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) who are taking antihypertensive treatment that doesn't allow them to have controlled blood pressure.
Study participants are asked to:
Wear the Aktiia bracelet continuously every day for 4 to 19 weeks in total, depending on the study group, Initialize their bracelet with the Aktiia cuff at different time points, Measure their blood pressure with an HBPM (Aktiia cuff) twice per day, Take their BP-lowering medications during the treatment periods, Complete 2 to 3 different surveys, depending on the study group, to give their feedback on Aktiia product use compared to HBPM.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 3
- Model description
- Study participants are asked to wear the Aktiia bracelet continuously every day for 4 to 19 weeks in total, depending on the study group, and initialize their Aktiia bracelet with the Aktiia cuff at different timepoints. In parallel, GROUP 1 and 2 participants are asked to take 3 successive Blood Pressure lowering medications during 2 weeks per treatment. Treatment periods are followed by 2 weeks of washout. The order of drug intake is randomly assigned for every participant. GROUP 3 participants will receive and individualized antihypertensive medication assigned by the investigator.
| Arm | Type | Receives |
|---|---|---|
| Meds2023 GROUP 1 | Other | Other: Aktiia Optical Blood Pressure Monitoring (OBPM) device and antihypertensive drugs (monotherapy and bitherapy)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). |
| Meds2023 GROUP 2 | Other | Other: Aktiia Optical Blood Pressure Monitoring (OBPM) device and antihypertensive drugs (monotherapy)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. |
| Meds2023 GROUP 3 | Other | Other: Aktiia Optical Blood Pressure Monitoring (OBPM) device and individualized antihypertensive treatmentGROUP 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. |
Who may qualify
- Ages
- 21 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (30 listed)
- Subjects have contraindications to the study drugs
- Subjects with Hypertension Stage 3 (SBP/DBP >180/110 mmHg)
- 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.).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Aktiia Optical Blood Pressure Monitoring (OBPM) device and antihypertensive drugs (monotherapy and bitherapy)Also: Aktiia system, Aktiia device, Aktiia bracelet, Aktiia cuffThe device under test is Aktiia Optical Blood Pressure Monitoring (OBPM) device and the comparator is the Aktiia cuff. For study GROUP 1: Study drugs are: * Perindopril MEPHA (Angiotensin Converting Enzyme (ACE) inhibitors). * Indapamide MEPHA (Diuretics). * Amlodipine MEPHA (Calcium channel blockers). In each study treatment period, subjects in GROUP 1 will receive one of the following for each treatment period: monotherapy with Indapamide, bitherapy with Indapamide plus Perindopril, or bitherapy with Perindopril plus Amlodipine. | Other | Meds2023 GROUP 1 |
| Aktiia Optical Blood Pressure Monitoring (OBPM) device and antihypertensive drugs (monotherapy)Also: Aktiia system, Aktiia device, Aktiia bracelet, Aktiia cuffStudy drugs: * Perindopril MEPHA (Angiotensin Converting Enzyme (ACE) inhibitors). * Indapamide MEPHA (Diuretics). * Amlodipine MEPHA (Calcium channel blockers). In each study treatment period, subjects in GROUP 2 will receive one of the following monotherapies: Perindopril , Indapamide, or Amlodipine. | Other | Meds2023 GROUP 2 |
| Aktiia Optical Blood Pressure Monitoring (OBPM) device and individualized antihypertensive treatmentAlso: Aktiia system, Aktiia device, Aktiia bracelet, Aktiia cuffFor study GROUP 3: Subjects will be prescribed an individualized new antihypertensive treatment at their consultation with the Investigator at Visit 1. | Other | Meds2023 GROUP 3 |
Primary outcome
Daytime Systolic and Diastolic Blood Pressure averages (last 3 days of week 1 versus last 3 days of week 3)
Time frame: Last 3 days of the washout period (week 1), against the last 3 days of the treatment period (week 3)
Statistics on the comparison of the changes in average daytime Blood Pressure values pre- and post-intervention between the two modalities (Aktiia device and HBPM)
Daytime Systolic and Diastolic Blood Pressure averages (last 3 days of week 5 versus last 3 days of week 7)
Time frame: Last 3 days of the washout period (week 5), against the last 3 days of the treatment period (week 7)
Statistics on the comparison of the changes in average daytime Blood Pressure values pre- and post-intervention between the two modalities (Aktiia device and HBPM)
Daytime Systolic and Diastolic Blood Pressure averages (last 3 days of week 9 versus last 3 days of week 11)
Time frame: Last 3 days of the washout period (week 9), against the last 3 days of the treatment period (week 11)
Statistics on the comparison of the changes in average daytime Blood Pressure values pre- and post-intervention between the two modalities (Aktiia device and HBPM)
3 secondary outcomes
Participant's compliance
Time frame: GROUP 1= 13 weeks; GROUP 2= 19 weeks; GROUP 3= 4 weeks.
Participant's compliance
Time frame: GROUP 1= 13 weeks; GROUP 2= 19 weeks; GROUP 3= 4 weeks.
Participant's perception
Time frame: GROUP 1= 13 weeks; GROUP 2= 19 weeks; GROUP 3= 4 weeks.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Pascale Vermare, Master contact
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Aktiia Optical Blood Pressure Monitoring (OBPM) device and antihypertensive drugs (monotherapy and bitherapy), Aktiia Optical Blood Pressure Monitoring (OBPM) device and antihypertensive drugs (monotherapy) and Aktiia Optical Blood Pressure Monitoring (OBPM) device and individualized antihypertensive treatment in people with Hypertension, run by Aktiia SA at 3 sites in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 30 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 5 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Cléo Moulin, Master (+41798336172, cleo.moulin@aktiia.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Daytime Systolic and Diastolic Blood Pressure averages (last 3 days of week 1 versus last 3 days of week 3) (time frame: Last 3 days of the washout period (week 1), against the last 3 days of the treatment period (week 3)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Feb 2026.