HypertensionNCT06368206
Recording of Physiological Data Via an Optical Sensor At the Fingertip Alongside with Double Auscultatory and Pulse Oximetry to Evaluate the Effectiveness of an Optical Blood Pressure Monitoring (OBPM)
A study testing Investigational device Aktiia G2C, Marketed device used as reference for blood pressure monitoring: double auscultation cuff and Marketed device used as comparative device for blood pressure and pulse rate monitoring: Aktiia Bracelet G2 in people with Hypertension, run by Aktiia SA at 1 site in Switzerland.
Trial summary
The present study, OBPM_Calfree2024, with N = 85 participants minimum over 1 visit (lasting around 1h), has been designed to collect raw optical data with Aktiia.product-G2C Clinical investigational system together with several reference systems within a cohort of subjects characterized by a wide variety of phenotypes. Read more about this study
- Who is it for?
- Ages 21 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Hypertension
- What is being tested?
- Investigational device Aktiia G2C, Marketed device used as reference for blood pressure monitoring: double auscultation cuff and Marketed device used as comparative device for blood pressure and pulse rate monitoring: Aktiia Bracelet G2
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 85 participants
- Where
- 1 siteSwitzerland
- Study dates
- 25 Jun 2024to 31 Dec 2025
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Subjects aged 21 to 85yo
- Subjects fluent in written and spoken French
- Subjects agreeing to attend the study visit and follow study procedures
- Subjects that have signed the informed consent form.
Who cannot join
- Amputated index fingers
- Damaged/injured skin at index fingers
- Damaged/injured skin at wrists
- Subjects suffering from sustained cardiac arrhythmias that can lead to weak or unstable pressure pulses including tachycardia (heart rate at rest > 120bpm) and atrial fibrillation
- Subjects suffering from pathologies that systematically reduce peripheral perfusion including Raynaud's disease, diabetes, renal dysfunctions (eGFR < 30mL/min/1.73 m2), hyper-/hypothyroidism, pheochromocytoma or arteriovenous fistula
- Pregnant women
- Polyneuropathy
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Switzerland1 site, 1 recruiting
- Recruiting
CHUV
Lausanne, 1011
Grégoire Wuerzner, MD Prof, +41213141131, gregoire.wuerzner@chuv.ch
About this study
Official title: Recording of Physiological Data Via an Optical Sensor At the Fingertip Alongside with Double Auscultatory and Pulse Oximetry to Evaluate the Effectiveness of an Optical Blood Pressure Monitoring (OBPM) Algorithm That Requires No Calibration with an External Cuff: a Single-center Prospective Clinical Study
The present study, OBPM_Calfree2024, with N = 85 participants minimum over 1 visit (lasting around 1h), has been designed to collect raw optical data with Aktiia.product-G2C Clinical investigational system together with several reference systems within a cohort of subjects characterized by a wide variety of phenotypes.
- Conditions
- Hypertension
- Being tested
- Investigational device Aktiia G2C, Marketed device used as reference for blood pressure monitoring: double auscultation cuff, Marketed device used as comparative device for blood pressure and pulse rate monitoring: Aktiia Bracelet G2, Marketed device used as comparative device for blood pressure and pulse rate monitoring: oscillometric upper-arm cuff, Marketed device used as comparative device for blood pressure and pulse rate monitoring: oscillometric wrist cuff
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Investigational device Aktiia G2CDevice
Study subjects are asked to stay seated and relaxed while successive measurements are taken with Aktiia G2C.
Marketed device used as reference for blood pressure monitoring: double auscultation cuffDevice
Study subjects are asked to stay seated and relaxed while successive measurements are taken with cuff for double auscultation.
Marketed device used as comparative device for blood pressure and pulse rate monitoring: Aktiia Bracelet G2Device
Study subjects are asked to stay seated and relaxed while successive measurements are taken with Aktiia Bracelet G2.
Marketed device used as comparative device for blood pressure and pulse rate monitoring: oscillometric upper-arm cuffDevice
Study subjects are asked to stay seated and relaxed while taking successive measurements with an oscillometric upper-arm cuff.
Marketed device used as comparative device for blood pressure and pulse rate monitoring: oscillometric wrist cuffDevice
Study subjects are asked to stay seated and relaxed while taking successive measurements with an oscillometric wrist cuff.
Marketed device used as reference for pulse rate monitoring: pulse finger oximeterDevice
Study subjects are asked to stay seated and relaxed while successive measurements are taken with pulse finger oximeter.
| Study group | Role | What they receive |
|---|---|---|
| Aktiia G2C and references/ comparators for Blood Pressure and Pulse Rate monitoring | Other | All study participants will test the investigational device (Aktiia G2C) and other marketed devices for blood pressure and pulse rate measurements (Aktiia Bracelet G2, Double auscultation, oscillometric monitors, finger pulse oximeter). Receives: Device: Investigational device Aktiia G2C; Device: Marketed device used as reference for blood pressure monitoring: double auscultation cuff; Device: Marketed device used as comparative device for blood pressure and pulse rate monitoring: Aktiia Bracelet G2; Device: Marketed device used as comparative device for blood pressure and pulse rate monitoring: oscillometric upper-arm cuff; Device: Marketed device used as comparative device for blood pressure and pulse rate monitoring: oscillometric wrist cuff; Device: Marketed device used as reference for pulse rate monitoring: pulse finger oximeter |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of study subjects that contribute with analyzable raw data collected
Min 85 study subjects contribute with analyzable raw data collected
Measured: 1 hour
Secondary outcomes (3)
Blood pressure mean value of differences
The mean value of the differences between Aktiia G2C and double auscultation blood pressure measurements.
Measured: 1 hour
Blood pressure standard deviation of differences
The mean value of the differences between Aktiia G2C and double auscultation blood pressure measurements.
Measured: 1 hour
Pulse rate root-mean-square error
The root-mean-square difference between the Aktiia G2C pulse rate determinations and the reference method.
Measured: 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2024
- Study start25 Jun 2024
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Not applicable
- Intervention model
- Single group
- Model description
- 1 study cohort that will test investigational device (Aktiia G2C) and Blood Pressure and Pulse Rate references.
- Masking
- None (open label)
- Enrolment
- 85 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
- NCT06368206
- Sponsor's protocol ID
- OBPM_Calfree2024
- Status last verified
- Dec 2024
- First submitted
- 4 Apr 2024
- Last updated
- 17 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Zahnd J, Thompson B, Rigon PA, Taffe P, Wuerzner G. Comparison of two validated oscillometric devices in a home-like setup reveals pronounced blood pressure differences and reduced precision. Hypertens Res. 2026 Mar;49(3):969-973. doi: 10.1038/s41440-025-02514-3. Epub 2026 Jan 9.
PubMed 41514019
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Recording of Physiological Data Via an Optical Sensor At the Fingertip Alongside with Double Auscultatory and Pulse Oximetry to Evaluate the Effectiveness of an Optical Blood Pressure Monitoring (OBPM) Algorithm That Requires No Calibration with an External Cuff: a Single-center Prospective Clinical Study
- ClinicalTrials.gov ID
- NCT06368206
- Acronym / sponsor ID
- OBPM_Calfree2024
- Conditions
- Hypertension
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 85 participants (estimated)
- Lead sponsor
- Aktiia SAIndustry (pharma, biotech, devices)
- Study start
- 25 Jun 2024 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 16 Apr 2024 (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.
The present study, OBPM_Calfree2024, with N = 85 participants minimum over 1 visit (lasting around 1h), has been designed to collect raw optical data with Aktiia.product-G2C Clinical investigational system together with several reference systems within a cohort of subjects characterized by a wide variety of phenotypes.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 1 study cohort that will test investigational device (Aktiia G2C) and Blood Pressure and Pulse Rate references.
| Arm | Type | Receives |
|---|---|---|
| Aktiia G2C and references/ comparators for Blood Pressure and Pulse Rate monitoring | Other | Device: Investigational device Aktiia G2C, Device: Marketed device used as reference for blood pressure monitoring: double auscultation cuff, Device: Marketed device used as comparative device for blood pressure and pulse rate monitoring: Aktiia Bracelet G2, Device: Marketed device used as comparative device for blood pressure and pulse rate monitoring: oscillometric upper-arm cuff, Device: Marketed device used as comparative device for blood pressure and pulse rate monitoring: oscillometric wrist cuff, Device: Marketed device used as reference for pulse rate monitoring: pulse finger oximeterAll study participants will test the investigational device (Aktiia G2C) and other marketed devices for blood pressure and pulse rate measurements (Aktiia Bracelet G2, Double auscultation, oscillometric monitors, finger pulse oximeter). |
Who may qualify
- Ages
- 21 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Subjects aged 21 to 85yo
- Subjects fluent in written and spoken French
- Subjects agreeing to attend the study visit and follow study procedures
- Subjects that have signed the informed consent form.
Key exclusion criteria (7 listed)
- Amputated index fingers
- Damaged/injured skin at index fingers
- Damaged/injured skin at wrists
- Subjects suffering from sustained cardiac arrhythmias that can lead to weak or unstable pressure pulses including tachycardia (heart rate at rest > 120bpm) and atrial fibrillation
- Subjects suffering from pathologies that systematically reduce peripheral perfusion including Raynaud's disease, diabetes, renal dysfunctions (eGFR < 30mL/min/1.73 m2), hyper-/hypothyroidism, pheochromocytoma or arteriovenous fistula
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 |
|---|---|---|
| Investigational device Aktiia G2CStudy subjects are asked to stay seated and relaxed while successive measurements are taken with Aktiia G2C. | Device | Aktiia G2C and references/ comparators for Blood Pressure and Pulse Rate monitoring |
| Marketed device used as reference for blood pressure monitoring: double auscultation cuffStudy subjects are asked to stay seated and relaxed while successive measurements are taken with cuff for double auscultation. | Device | Aktiia G2C and references/ comparators for Blood Pressure and Pulse Rate monitoring |
| Marketed device used as comparative device for blood pressure and pulse rate monitoring: Aktiia Bracelet G2Study subjects are asked to stay seated and relaxed while successive measurements are taken with Aktiia Bracelet G2. | Device | Aktiia G2C and references/ comparators for Blood Pressure and Pulse Rate monitoring |
| Marketed device used as comparative device for blood pressure and pulse rate monitoring: oscillometric upper-arm cuffStudy subjects are asked to stay seated and relaxed while taking successive measurements with an oscillometric upper-arm cuff. | Device | Aktiia G2C and references/ comparators for Blood Pressure and Pulse Rate monitoring |
| Marketed device used as comparative device for blood pressure and pulse rate monitoring: oscillometric wrist cuffStudy subjects are asked to stay seated and relaxed while taking successive measurements with an oscillometric wrist cuff. | Device | Aktiia G2C and references/ comparators for Blood Pressure and Pulse Rate monitoring |
| Marketed device used as reference for pulse rate monitoring: pulse finger oximeterStudy subjects are asked to stay seated and relaxed while successive measurements are taken with pulse finger oximeter. | Device | Aktiia G2C and references/ comparators for Blood Pressure and Pulse Rate monitoring |
Primary outcome
Number of study subjects that contribute with analyzable raw data collected
Time frame: 1 hour
Min 85 study subjects contribute with analyzable raw data collected
3 secondary outcomes
Blood pressure mean value of differences
Time frame: 1 hour
Blood pressure standard deviation of differences
Time frame: 1 hour
Pulse rate root-mean-square error
Time frame: 1 hour
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 17 Dec 2024.
- Derived from this study: PubMed 41514019Zahnd J, Thompson B, Rigon PA, Taffe P, Wuerzner G. Comparison of two validated oscillometric devices in a home-like setup reveals pronounced blood pressure differences and reduced precision. Hypertens Res. 2026 Mar;49(3):969-973. doi: 10.1038/s41440-025-02514-3. Epub 2026 Jan 9.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Investigational device Aktiia G2C, Marketed device used as reference for blood pressure monitoring: double auscultation cuff and Marketed device used as comparative device for blood pressure and pulse rate monitoring: Aktiia Bracelet G2 in people with Hypertension, run by Aktiia SA at 1 site 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 4 inclusion and 7 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 17 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 Grégoire Wuerzner, Medical Doctor Prof. (+41213140223, gregoire.wuerzner@chuv.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of study subjects that contribute with analyzable raw data collected (time frame: 1 hour). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06368206, which also lists 1 linked publication.
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 17 Dec 2024.