HypertensionNCT06565780
Evaluation of the Performance and Safety of the Aktiia Spot-check Optical Blood Pressure Monitoring Device At Wrist Against Double Auscultation
A study testing Device under test evaluation against references in people with Hypertension, run by Aktiia SA at 1 site in United States.
Trial summary
This study, with N = 85 participants minimum over 3 visits spread over 23 hours, has been designed to assess the accuracy and precision of the Blood Pressure and pulse rate values as generated by Aktiia.product-G0 for up to 23 hours after initialization in a cohort of subjects representative of the US population. Read more about this study
- Who is it for?
- Ages 22 to 59 yearsHealthy volunteers can take part
- Conditions the study is for
- Hypertension
- What is being tested?
- Device under test evaluation against references
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Sep 2024to 10 Jan 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 22 to 59 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Participants must be able to provide an informed consent to participate.
- Participant must be willing and able to comply with all of the study procedures and return for a day 2 visit.
- Participants must be 22 to 59 years of age.
- Participant or witness must be able to read or write in English.
Who cannot join
- Participants with compromised circulation, injury, or physical malformation of the equipment test sites or other sensor sites which would limit the ability to test sites needed for the study. (Note: Certain malformations may still allow participants to participate if the condition is noted and would not affect the sites utilized.)
- Female participants who are known to be pregnant or who are trying to get pregnant confirmed by a day 1 positive urine pregnancy test unless the study participant is known to be not of child-bearing potential.
- Participants with known clotting disorders or currently taking a prescription blood thinner.
- Other known health conditions that will prevent safe participation in the study upon disclosure in Health Assessment Short Form or verbally.
- Participants suffering from sustained cardiac arrhythmias that can lead to weak or unstable pressure pulses including tachycardia (heart rate at rest > 120bpm) and atrial fibrillation.
- Participants suffering from pathologies that systematically reduce peripheral perfusion including Raynaud's disease, diabetes, renal dysfunctions (eGFR < 60mL / min / 1.73 m2), hyper- / hypothyroidism, pheochromocytoma or arteriovenous fistula.
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- A wrist circumference below 14 cm or above 23 cm.
- An upper arm circumference < 22cm or > 42cm.
- Any subject that, in the opinion of the investigator, does not exhibit any phenotype relevant to the objectives of this study.
- Any condition or circumstance that, in the opinion of the investigator, may preclude study completion, interfere with accurate data collection, bias the results, by instance a subject presenting a lateral Blood Pressure difference at screening of more than 15 mmHg for the systolic and/or more than 10 mmHg for the diastolic.
Trial locations and contacts
1 site in 1 country.
United States1 site
Parameters Research Laboratory
Broomfield, Colorado, 80021
About this study
Official title: Evaluation of the Performance and Safety of the Aktiia Spot-check Optical Blood Pressure Monitoring (OBPM) Device At Wrist Against Double Auscultation: a Multicentric Prospective Clinical Study
This study, with N = 85 participants minimum over 3 visits spread over 23 hours, has been designed to assess the accuracy and precision of the Blood Pressure and pulse rate values as generated by Aktiia.product-G0 for up to 23 hours after initialization in a cohort of subjects representative of the US population.
For the study, subjects will be asked to stay seated while measurements are taken at different timepoints.
- Conditions
- Hypertension
- Being tested
- Device under test evaluation against references
- 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.
Device under test evaluation against referencesDevice
Subjects will be asked to stay seated while blood pressure and pulse rate measurements are taken at different timepoints with the device under test and references.
Device under Test: Aktiia.product-G0 References: Cuff for double auscultation for blood pressure and Electrocardiogram for pulse rate.
| Study group | Role | What they receive |
|---|---|---|
| Aktiia.product-G0 device under test | Other | Subjects will be asked to stay seated while blood pressure and pulse rate measurements are taken at different timepoints with the device under test and references. Receives: Device: Device under test evaluation against references |
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-G0 and double auscultation blood pressure measurements.
Measured: 23 hours
Blood pressure standard deviation of differences
The standard deviation of the differences between Aktiia.product-G0 and double auscultation blood pressure measurements.
Measured: 23 hours
Secondary outcomes (1)
Heart rate root-mean-square error
The root-mean-square difference between the Aktiia.product-G0 heart rate determinations and the reference method.
Measured: 23 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2024
- Study start23 Sep 2024
- Primary completion10 Jan 2025
- Study completion10 Jan 2025
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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 140 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aktiia SA
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06565780
- Sponsor's protocol ID
- OBPM_FOX2024
- Status last verified
- Feb 2025
- First submitted
- 19 Aug 2024
- Last updated
- 18 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Performance and Safety of the Aktiia Spot-check Optical Blood Pressure Monitoring (OBPM) Device At Wrist Against Double Auscultation: a Multicentric Prospective Clinical Study
- ClinicalTrials.gov ID
- NCT06565780
- Acronym / sponsor ID
- OBPM_FOX2024
- Conditions
- Hypertension
- Keywords
- hypertension, blood pressure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 140 participants (actual)
- Lead sponsor
- Aktiia SAIndustry (pharma, biotech, devices)
- Study start
- 23 Sep 2024 (actual)
- Primary completion
- 10 Jan 2025 (actual)
- Study completion
- 10 Jan 2025 (actual)
- First posted
- 22 Aug 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.
This study, with N = 85 participants minimum over 3 visits spread over 23 hours, has been designed to assess the accuracy and precision of the Blood Pressure and pulse rate values as generated by Aktiia.product-G0 for up to 23 hours after initialization in a cohort of subjects representative of the US population.
For the study, subjects will be asked to stay seated while measurements are taken at different timepoints.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Aktiia.product-G0 device under test | Other | Device: Device under test evaluation against referencesSubjects will be asked to stay seated while blood pressure and pulse rate measurements are taken at different timepoints with the device under test and references. |
Who may qualify
- Ages
- 22 to 59 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Participants must be able to provide an informed consent to participate.
- Participant must be willing and able to comply with all of the study procedures and return for a day 2 visit.
- Participants must be 22 to 59 years of age.
- Participant or witness must be able to read or write in English.
Key exclusion criteria (10 listed)
- Participants with compromised circulation, injury, or physical malformation of the equipment test sites or other sensor sites which would limit the ability to test sites needed for the study. (Note: Certain malformations may still allow participants to participate if the condition is noted and would not affect the sites utilized.)
- Female participants who are known to be pregnant or who are trying to get pregnant confirmed by a day 1 positive urine pregnancy test unless the study participant is known to be not of child-bearing potential.
- Participants with known clotting disorders or currently taking a prescription blood thinner.
- Other known health conditions that will prevent safe participation in the study upon disclosure in Health Assessment Short Form or verbally.
- Participants suffering from sustained cardiac arrhythmias that can lead to weak or unstable pressure pulses including tachycardia (heart rate at rest > 120bpm) and atrial fibrillation.
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 |
|---|---|---|
| Device under test evaluation against referencesSubjects will be asked to stay seated while blood pressure and pulse rate measurements are taken at different timepoints with the device under test and references. Device under Test: Aktiia.product-G0 References: Cuff for double auscultation for blood pressure and Electrocardiogram for pulse rate. | Device | Aktiia.product-G0 device under test |
Primary outcome
Blood pressure mean value of differences
Time frame: 23 hours
The mean value of the differences between Aktiia.product-G0 and double auscultation blood pressure measurements.
Blood pressure standard deviation of differences
Time frame: 23 hours
The standard deviation of the differences between Aktiia.product-G0 and double auscultation blood pressure measurements.
1 secondary outcome
Heart rate root-mean-square error
Time frame: 23 hours
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 18 Feb 2025.
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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 Device under test evaluation against references in people with Hypertension, run by Aktiia SA at 1 site in United States.
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 10 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 18 Feb 2025. 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 United States. 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?
Blood pressure mean value of differences (time frame: 23 hours). 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 18 Feb 2025.