HypertensionNCT05236348
Performance of the Aktiia Optical Blood Pressure Monitoring Device Against Double Auscultation
A study testing Aktiia.product-us in people with Hypertension and Blood Pressure, run by Aktiia SA at 1 site in Switzerland.
Trial summary
This study with N = 225 participants (1 cohort of a minimum of 85 and maximum of 140 participants, and an additional cohort with 85 participants) over 9 visits has been designed to assess the accuracy of Aktiia.product-us systolic and diastolic blood pressure measurements against double-auscultation reference… Read more about this study
- Who is it for?
- Ages 21 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Hypertension, Blood Pressure, Heart Rate
- What is being tested?
- Aktiia.product-us
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 225 participants
- Where
- 1 siteSwitzerland
- Study dates
- 11 Jan 2022to 31 Mar 2025
- 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 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adult subjects (aged between 21 and 85 years old)
- Subjects can read and speak French
- Subjects can perform simple physical exercises
- Subjects agreeing to attend the totality of 9 visits
- Subjects that have signed the informed consent form
Who cannot join
- Clinical staff collaborating with study PI
- Subjects with tachycardia (heart rate at rest > 120bpm)
- Subjects with atrial fibrillation
- Subjects with diabetes
- Subjects with renal dysfunctions
- Subjects with hyper-/hypothyroidism
Show all 19Show fewer
- Subjects with pheochromocytoma
- Subjects with Raynaud's disease
- 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 (for ARM 1 only)
- Subjects with an arteriovenous fistula
- Subjects with arm amputations
- Subjects with the upper arm circumference < 22cm or > 42 cm
- Subjects with the wrist circumference > 21 cm
- Subjects with the exfoliative skin diseases
- Subjects with lymphoedema
Trial locations and contacts
1 site in 1 country.
Switzerland1 site, 1 recruiting
- Recruiting
University of Lausanne Hospitals
Lausanne, 1011
Grégoire Wuerzner, MD, +41213141131, gregoire.wuerzner@chuv.ch
About this study
Official title: Single-center Prospective Clinical Trial to Validate the Performance of the Aktiia Optical Blood Pressure Monitoring (OBPM) Device at the Wrist Against Double Auscultation
This study with N = 225 participants (1 cohort of a minimum of 85 and maximum of 140 participants, and an additional cohort with 85 participants) over 9 visits has been designed to assess the accuracy of Aktiia.product-us systolic and diastolic blood pressure measurements against double-auscultation reference measurements. In order to induce blood pressure changes and to simulate ambulatory scenarios, the study participants will be asked to perform a set of activities, involving body position changes and physical exercises. Additionally, this study will compare the heart rate measured by Aktiia.product-us against the reference readings provided by a finger pulse oximeter (as per ISO80601-2-61). The reliability of the auscultation readings will be controlled with simultaneous volume-clamp measurements.
Read the detailed description
According to the World Health Organization, by 2025 hypertension will affect 1.5 billion adults worldwide. Half of the adult population suffering from hypertension is currently not diagnosed and half of the treated population is not at the defined target of BP.
Widespread use of out-of-office Blood Pressure measurement is one of the proposed strategies to fight against hypertension worldwide.
Aktiia S.A. has developed an intermittent automated non-invasive cuffless blood pressure monitor, determining the values of the systolic blood pressure, the diastolic blood pressure and the heart rate. This miniature device is comfortably positioned with a bracelet on a user's wrist.
The goal of this study is to establish a reasonable assurance of safety and effectiveness with Aktiia OBPM system for monitoring blood pressure in home use.
In particular, the study will collect data from subjects by means of the device under test and collect data from subjects by means of double-auscultation, pulse oximetry and volume-clamp BP reading while subjects wear the devices at different body positions and induce Blood Pressure changes, during eight visits that will be held over the span of seven days, and generate performance reports.
- Conditions
- Hypertension, Blood Pressure, Heart Rate
- Being tested
- Aktiia.product-us
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aktiia.product-usDevice
Also called Aktiia bracelet, Aktiia product, Aktiia.product
The study will collect data from subjects by means of the device under test and collect data from subjects by means of double-auscultation, pulse oximetry and volume-clamp BP reading while subjects wear the devices at different body positions and induce BP changes, during eight visits that will be held over the span of seven days, and generate performance reports.
| Study group | Role | What they receive |
|---|---|---|
| Patients 21-60yo with Aktiia.product-us | Experimental | All study participants will wear the Aktiia.product-us during 9 visits that will be held over the span of seven days. Receives: Device: Aktiia.product-us |
| Patients 60-85yo with Aktiia.product-us | Experimental | All study participants will wear the Aktiia.product-us during 9 visits that will be held over the span of seven days. Receives: Device: Aktiia.product-us |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood pressure mean value of differences
The mean value of the differences between Aktiia.product-us and double auscultation blood pressure measurements.
Measured: 1 week
Blood pressure standard deviation of differences
The standard deviation of the differences between Aktiia.product-us and double auscultation blood pressure measurements.
Measured: 1 week
Secondary outcomes (1)
Heart rate root-mean-square error
The root-mean-square difference between the Aktiia.product-us heart rate determinations and the reference method.
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2022
- Study start11 Jan 2022
- Primary completion31 Mar 2025 (estimated)
- Study completion31 Mar 2025 (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
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Model description
- All study participants will wear the Aktiia.bracelet-us during 9 visits that will be held over the span of seven days. In order to induce blood pressure changes and to simulate ambulatory scenarios, the study participants will be asked to perform a set of activities, involving body position changes and physical exercises during these visits.
- Masking
- None (open label)
- Enrolment
- 225 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aktiia SA
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Gregoire Wuerzner, MD, Principal investigator, Service of Nephrology and Hypertension CHUV
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05236348
- Sponsor's protocol ID
- OBPM_Auscultatory2022
- Status last verified
- Aug 2024
- First submitted
- 28 Dec 2021
- Last updated
- 19 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Single-center Prospective Clinical Trial to Validate the Performance of the Aktiia Optical Blood Pressure Monitoring (OBPM) Device at the Wrist Against Double Auscultation
- ClinicalTrials.gov ID
- NCT05236348
- Acronym / sponsor ID
- OBPM_Auscultatory2022
- Conditions
- Hypertension, Blood Pressure, Heart Rate
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 225 participants (estimated)
- Lead sponsor
- Aktiia SAIndustry (pharma, biotech, devices)
- Study start
- 11 Jan 2022 (actual)
- Primary completion
- 31 Mar 2025 (estimated)
- Study completion
- 31 Mar 2025 (estimated)
- First posted
- 11 Feb 2022 (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 with N = 225 participants (1 cohort of a minimum of 85 and maximum of 140 participants, and an additional cohort with 85 participants) over 9 visits has been designed to assess the accuracy of Aktiia.product-us systolic and diastolic blood pressure measurements against double-auscultation reference measurements. In order to induce blood pressure changes and to simulate ambulatory scenarios, the study participants will be asked to perform a set of activities, involving body position changes and physical exercises. Additionally, this study will compare the heart rate measured by Aktiia.product-us against the reference readings provided by a finger pulse oximeter (as per ISO80601-2-61). The reliability of the auscultation readings will be controlled with simultaneous volume-clamp measurements.
Detailed description
According to the World Health Organization, by 2025 hypertension will affect 1.5 billion adults worldwide. Half of the adult population suffering from hypertension is currently not diagnosed and half of the treated population is not at the defined target of BP.
Widespread use of out-of-office Blood Pressure measurement is one of the proposed strategies to fight against hypertension worldwide.
Aktiia S.A. has developed an intermittent automated non-invasive cuffless blood pressure monitor, determining the values of the systolic blood pressure, the diastolic blood pressure and the heart rate. This miniature device is comfortably positioned with a bracelet on a user's wrist.
The goal of this study is to establish a reasonable assurance of safety and effectiveness with Aktiia OBPM system for monitoring blood pressure in home use.
In particular, the study will collect data from subjects by means of the device under test and collect data from subjects by means of double-auscultation, pulse oximetry and volume-clamp BP reading while subjects wear the devices at different body positions and induce Blood Pressure changes, during eight visits that will be held over the span of seven days, and generate performance reports.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- All study participants will wear the Aktiia.bracelet-us during 9 visits that will be held over the span of seven days. In order to induce blood pressure changes and to simulate ambulatory scenarios, the study participants will be asked to perform a set of activities, involving body position changes and physical exercises during these visits.
| Arm | Type | Receives |
|---|---|---|
| Patients 21-60yo with Aktiia.product-us | Experimental | Device: Aktiia.product-usAll study participants will wear the Aktiia.product-us during 9 visits that will be held over the span of seven days. |
| Patients 60-85yo with Aktiia.product-us | Experimental | Device: Aktiia.product-usAll study participants will wear the Aktiia.product-us during 9 visits that will be held over the span of seven days. |
Who may qualify
- Ages
- 21 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Adult subjects (aged between 21 and 85 years old)
- Subjects can read and speak French
- Subjects can perform simple physical exercises
- Subjects agreeing to attend the totality of 9 visits
- Subjects that have signed the informed consent form
Key exclusion criteria (19 listed)
- Clinical staff collaborating with study PI
- Subjects with tachycardia (heart rate at rest > 120bpm)
- Subjects with atrial fibrillation
- Subjects with diabetes
- Subjects with renal dysfunctions
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.product-usAlso: Aktiia bracelet, Aktiia product, Aktiia.productThe study will collect data from subjects by means of the device under test and collect data from subjects by means of double-auscultation, pulse oximetry and volume-clamp BP reading while subjects wear the devices at different body positions and induce BP changes, during eight visits that will be held over the span of seven days, and generate performance reports. | Device | Patients 21-60yo with Aktiia.product-us, Patients 60-85yo with Aktiia.product-us |
Primary outcome
Blood pressure mean value of differences
Time frame: 1 week
The mean value of the differences between Aktiia.product-us and double auscultation blood pressure measurements.
Blood pressure standard deviation of differences
Time frame: 1 week
The standard deviation of the differences between Aktiia.product-us and double auscultation blood pressure measurements.
1 secondary outcome
Heart rate root-mean-square error
Time frame: 1 week
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2024.
- 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.
Gregoire Wuerzner, MD principal investigator
Service of Nephrology and Hypertension CHUV
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-us in people with Hypertension and Blood Pressure, 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 5 inclusion and 19 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: status not confirmed, as of the sponsor's last update on 19 Aug 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Josep Sola, PhD (+41797689800, josep@aktiia.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Blood pressure mean value of differences (time frame: 1 week). The study lists 2 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 19 Aug 2024.