Blood PressureOBPM_ABPM2020NCT04548986
Single-center Prospective Study to Validate the Performance of the Aktiia Optical Blood Pressure Monitoring (OBPM) Device at the Wrist Against Ambulatory Blood Pressure Monitoring (ABPM)
A study testing Aktiia.product in people with Blood Pressure and Hypertension, run by Cyril Pellaton at 1 site in Switzerland.
Trial summary
This study aims to assess the performances of optical blood pressure monitoring device, Aktiia.product in the context of cardiac rehabilitation program. Read more about this study
- Who is it for?
- Ages 21 to 65 years
- Conditions the study is for
- Blood Pressure, Hypertension
- What is being tested?
- Aktiia.product
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 63 participants
- Where
- 1 siteSwitzerland
- Study dates
- 6 Aug 2020to 23 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult subjects (aged between 21 and 65)
- Subjects fluent in written and spoken French
- Subjects enrolled in a 12-weeks cardiac rehabilitation program
- Subjects agreeing to participate
- Subjects that have signed the informed consent form
Who cannot join
- Subjects with tachycardia (heart rate at rest > 120bpm)
- Subjects with atrial fibrillation
- Subjects with severe heart failure (LVEF<35%)
- Subjects with severe renal dysfunctions (eGFR < 30mL/min/1.73 m2)
- Subjects with pheochromocytoma
- Subjects with Raynaud's disease
Show all 17Show fewer
- Subjects with trembling and shivering
- Subjects with interarm systolic difference > 15 mmHg
- Subjects with interarm diastolic difference > 10 mmHg
- Subjects with arm paralysis
- Women in known pregnancy
- Subjects with an arteriovenous fistula
- Subjects with arm amputations
- Subjects with the upper arm circumference > 64 cm
- Subjects with the wrist circumference > 22 cm
- Subjects with the exfoliative skin diseases
- Subjects with lymphoedema
Trial locations and contacts
1 site in 1 country.
About this study
This study aims to assess the performances of optical blood pressure monitoring device, Aktiia.product in the context of cardiac rehabilitation program.
- Conditions
- Blood Pressure, Hypertension
- Being tested
- Aktiia.product
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aktiia.productDevice
The participants wear Aktiia.bracelet for the duration of the cardiac rehabilitation program. The device is initialized once per week.
| Study group | Role | What they receive |
|---|---|---|
| single arm | Other | single arm study Receives: Device: Aktiia.product |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean absolute error for blood pressure
The mean absolute error between the Reference (standard ambulatory blood pressure monitor) and Aktiia.product for systolic (SYS) and diastolic (DIA) blood pressure in mmHg
Measured: up to 24 hours
Mean error for blood pressure
The mean error between the Reference and Aktiia.product for SYS and DIA in mmHg
Measured: up to 24 hours
Standard deviation of the error for blood pressure
The standard deviation of the error between Reference and Aktiia.product for SYS and DIA in mmHg
Measured: up to 24 hours
Mean absolute error for heart rate
The mean absolute error between the Reference (standard ambulatory blood pressure monitor) and Aktiia.product for heart rate in bpm
Measured: up to 24 hours
Mean error for heart rate
The mean error between the Reference and Aktiia.product for heart rate in bpm
Measured: up to 24 hours
Standard deviation of the error for heart rate
The standard deviation of the error between Reference and Aktiia.product for heart rate in bpm
Measured: up to 24 hours
Secondary outcomes (4)
Evaluation of the impact of ABPM induced stress on BP readings using inferential statistics.
Aktiia values acquired during the first day (with ABPM) will be compared to values acquired during other days of the week and a t-test will be performed. The analysis will be repeated for night values.
Measured: 1 week
Evaluation of patient's satisfaction for the two devices through a survey with multiple questions
10-points likert scale survey, an agree-disagree scale with minimum 0 and maximum 10. Minimum value means strong disagreement, maximum value means strong agreement.
Measured: up to 24 hours
Assessment of the calibration stability of Aktiia OBPM algorithms
Use different calibration points going from 1 to 12 weeks
Measured: 12 weeks
Assessment of systolic and diastolic blood pressure control during a 12 weeks cardiac rehabilitation program
comparison of blood pressure determinations taken at the beginning and at the end of the program in ambulatory settings
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2020
- Study start6 Aug 2020
- Primary completion23 Dec 2022
- Study completion23 Dec 2022
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 Blood PressureStudies 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
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 63 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cyril Pellaton
- Sponsor type
- University, hospital or other
- Collaborators
- Aktiia SA
- Responsible party
- Sponsor-investigator, Cyril Pellaton, Hopital Neuchatelois
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04548986
- Sponsor's protocol ID
- OBPM_ABPM2020
- Acronym
- OBPM_ABPM2020
- Status last verified
- Jan 2023
- First submitted
- 26 Aug 2020
- Last updated
- 25 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Almeida TP, Perruchoud D, Alexandre J, Vermare P, Sola J, Shah J, Marques L, Pellaton C. Evaluation of Aktiia cuffless blood pressure monitor across 24-h, daytime, and night-time measurements versus ambulatory monitoring: a prospective, single-centre observational study. J Hypertens. 2025 Apr 1;43(4):690-697. doi: 10.1097/HJH.0000000000003960. Epub 2025 Feb 7.
PubMed 39927495
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Single-center Prospective Study to Validate the Performance of the Aktiia Optical Blood Pressure Monitoring (OBPM) Device at the Wrist Against Ambulatory Blood Pressure Monitoring (ABPM)
- ClinicalTrials.gov ID
- NCT04548986
- Acronym / sponsor ID
- OBPM_ABPM2020 / OBPM_ABPM2020
- Conditions
- Blood Pressure, Hypertension
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 63 participants (actual)
- Lead sponsor
- Cyril PellatonUniversity, hospital or other
- Collaborators
- Aktiia SA
- Study start
- 6 Aug 2020 (actual)
- Primary completion
- 23 Dec 2022 (actual)
- Study completion
- 23 Dec 2022 (actual)
- First posted
- 16 Sep 2020 (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.
This study aims to assess the performances of optical blood pressure monitoring device, Aktiia.product in the context of cardiac rehabilitation program.
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| single arm | Other | Device: Aktiia.productsingle arm study |
Who may qualify
- Ages
- 21 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Adult subjects (aged between 21 and 65)
- Subjects fluent in written and spoken French
- Subjects enrolled in a 12-weeks cardiac rehabilitation program
- Subjects agreeing to participate
- Subjects that have signed the informed consent form
Key exclusion criteria (17 listed)
- Subjects with tachycardia (heart rate at rest > 120bpm)
- Subjects with atrial fibrillation
- Subjects with severe heart failure (LVEF<35%)
- Subjects with severe renal dysfunctions (eGFR < 30mL/min/1.73 m2)
- Subjects with pheochromocytoma
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.productThe participants wear Aktiia.bracelet for the duration of the cardiac rehabilitation program. The device is initialized once per week. | Device | single arm |
Primary outcome
Mean absolute error for blood pressure
Time frame: up to 24 hours
The mean absolute error between the Reference (standard ambulatory blood pressure monitor) and Aktiia.product for systolic (SYS) and diastolic (DIA) blood pressure in mmHg
Mean error for blood pressure
Time frame: up to 24 hours
The mean error between the Reference and Aktiia.product for SYS and DIA in mmHg
Standard deviation of the error for blood pressure
Time frame: up to 24 hours
The standard deviation of the error between Reference and Aktiia.product for SYS and DIA in mmHg
Mean absolute error for heart rate
Time frame: up to 24 hours
The mean absolute error between the Reference (standard ambulatory blood pressure monitor) and Aktiia.product for heart rate in bpm
Mean error for heart rate
Time frame: up to 24 hours
The mean error between the Reference and Aktiia.product for heart rate in bpm
Standard deviation of the error for heart rate
Time frame: up to 24 hours
The standard deviation of the error between Reference and Aktiia.product for heart rate in bpm
4 secondary outcomes
Evaluation of the impact of ABPM induced stress on BP readings using inferential statistics.
Time frame: 1 week
Evaluation of patient's satisfaction for the two devices through a survey with multiple questions
Time frame: up to 24 hours
Assessment of the calibration stability of Aktiia OBPM algorithms
Time frame: 12 weeks
Assessment of systolic and diastolic blood pressure control during a 12 weeks cardiac rehabilitation program
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jan 2023.
- Derived from this study: PubMed 39927495Almeida TP, Perruchoud D, Alexandre J, Vermare P, Sola J, Shah J, Marques L, Pellaton C. Evaluation of Aktiia cuffless blood pressure monitor across 24-h, daytime, and night-time measurements versus ambulatory monitoring: a prospective, single-centre observational study. J Hypertens. 2025 Apr 1;43(4):690-697. doi: 10.1097/HJH.0000000000003960. Epub 2025 Feb 7.
- 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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Aktiia.product in people with Blood Pressure and Hypertension, run by Cyril Pellaton 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 5 inclusion and 17 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: finished, as of the sponsor's last update on 25 Jan 2023. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean absolute error for blood pressure (time frame: up to 24 hours). The study lists 6 primary outcomes in all. 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 NCT04548986, 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 25 Jan 2023.