Blood Pressure Monitor for High Blood Pressure

Overseen By Arthur Cabrera, MD

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: Aktiia SA

Must not be taking: Blood thinners

Disqualifiers: Pregnancy, Clotting disorders, Arrhythmias, Diabetes, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 3

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests how well a new device, the Aktiia Spot-check Optical Blood Pressure Monitor, measures blood pressure and pulse over a 23-hour period. The goal is to determine if this device can accurately track these health metrics in individuals with high blood pressure. Participants must sit still while the device takes readings at various times. It suits those who understand and follow instructions in English, are not pregnant, and do not have certain health issues like severe circulation problems or heart rhythm disorders. As an unphased trial, this study allows participants to contribute to innovative research that could enhance blood pressure monitoring technology.

Do I have to stop taking my current medications for the trial?

The trial protocol does not specify if you need to stop taking your current medications. However, if you are taking a prescription blood thinner, you cannot participate in the study.

What prior data suggests that this blood pressure monitoring device is safe?

Research shows that the Aktiia Spot-check Optical Blood Pressure Monitoring Device uses Photoplethysmography (PPG) technology to collect data from the wrist. This technology, already used in some smartwatches and fitness trackers, is generally comfortable for most people.

One study examined the accuracy and precision of the Aktiia Bracelet, a similar device, over a month. The study found that the device provided accurate blood pressure readings, supporting its reliability. However, specific information on side effects or problems with this device is not available. This trial is labeled "Not Applicable" in terms of phases, indicating it is a study of a device, not a drug. Device studies often focus on whether the device functions correctly and is safe to use.

If a similar device is already approved for other uses, it usually suggests reasonable safety. However, new studies might provide additional information. Always consult healthcare professionals if there are concerns about joining a trial. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Aktiia Spot-check Optical Blood Pressure Monitoring Device because it offers a non-invasive and convenient way to monitor blood pressure. Unlike traditional blood pressure cuffs that can be cumbersome and require manual operation, this device uses optical sensors to measure blood pressure and pulse rate seamlessly. This technology allows for more frequent and accurate monitoring, which could lead to better management of high blood pressure. By providing comfort and ease of use, the device encourages regular monitoring, potentially leading to earlier intervention and improved outcomes for patients.

What evidence suggests that the Aktiia Spot-check Optical Blood Pressure Monitoring Device is effective for monitoring high blood pressure?

Research has shown that the Aktiia Spot-check Optical Blood Pressure Monitoring Device, used by participants in this trial, provides reliable blood pressure readings. It employs Photoplethysmography (PPG) technology to measure changes in blood flow at the wrist, enabling continuous blood pressure tracking throughout the day. Studies have found its results closely match those of traditional blood pressure monitors, with only minor differences. This consistency allows the device to effectively monitor blood pressure over time. Designed for ease of use, it tracks blood pressure without interrupting daily activities. ^{2 3 6 7 8}

Are You a Good Fit for This Trial?

This trial is for at least 85 adults with high blood pressure, representative of the US population. Participants will need to be available for 8 visits over a day and stay seated during measurements.

Inclusion Criteria

Participants must be able to provide an informed consent to participate

I am willing and able to follow the study rules and come back for a visit on day 2.

Participant or witness must be able to read or write in English

Exclusion Criteria

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

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Measurement

Participants undergo blood pressure and pulse rate measurements using the Aktiia.product-G0 device and reference methods

23 hours

3 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after measurements

1 week

What Are the Treatments Tested in This Trial?

Interventions

• Aktiia Spot-check Optical Blood Pressure Monitoring Device

Trial Overview

The study tests the Aktiia Spot-check Optical Blood Pressure Monitoring Device's accuracy in measuring blood pressure and pulse rate against standard methods, over a period of up to 23 hours.

How Is the Trial Designed?

Group I: Aktiia.product-G0 device under test Experimental Treatment 1 Intervention

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.

Who Is Running the Clinical Trial?

Aktiia SA

Lead Sponsor

Trials

12

Recruited

23,600+

Published Research Related to This Trial

The Aktiia Bracelet, a noninvasive optical blood pressure monitor, demonstrated good accuracy in measuring blood pressure over a month-long study with 86 participants, meeting the ISO81060-2 validation criteria.

The device showed a mean difference of only 0.46 mmHg for systolic blood pressure and 0.39 mmHg for diastolic blood pressure compared to standard measurements, indicating its potential reliability for regular blood pressure monitoring in adults.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Blood pressure from the optical Aktiia Bracelet: a 1-month validation study using an extended ISO81060-2 protocol adapted for a cuffless wrist device. Vybornova, A., Polychronopoulou, E., Wurzner-Ghajarzadeh, A., et al.[2023]

The Oregon Scientific BPU 330 blood pressure monitor was validated for accuracy using the International Protocol, showing that it can reliably measure blood pressure in adults, with most readings falling within acceptable ranges compared to a mercury sphygmomanometer.

Out of 52 participants, the device passed validation phases, demonstrating that it is suitable for self-monitoring of blood pressure, making it a safe option for consumers looking to manage their health at home.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Validation of the Oregon Scientific BPU 330 for self-monitoring of blood pressure according to the International Protocol. Li, L., Zhang, X., Yan, C., et al.[2021]

The PG-800A36 automatic wrist blood pressure monitor was validated through rigorous testing with 118 participants, meeting the standards set by both the European Society of Hypertension and the British Hypertension Society.

It demonstrated high accuracy in measuring blood pressure, with average differences from standard measurements well within acceptable limits, making it a reliable option for self-monitoring blood pressure in the general population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Validation of the Pangao PG-800A36 automatic wrist blood pressure monitor according to the European Society of Hypertension and the British Hypertension Society protocols. Zhao, H., Qiao, W., Zhang, R., et al.[2019]

A study of 110 eyes found a significant correlation between ophthalmic artery pressure and brachial arterial pressure, indicating that measurements of these two pressures are related.

The mean systolic ophthalmic artery pressure was 114.5 mmHg, and interestingly, in some cases, the ophthalmic pressure exceeded the brachial pressure, suggesting potential ocular-vascular reflexes that could affect pressure readings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Measurement of arterial tension at the eye with the Stepanik arteriotonograph (author's transl)]. DaSilva, FA., Krieglstein, GK., von Collani, E.[2009]

In a study involving 52 patients over a 12-week cardiac rehabilitation program, the cuffless Aktiia monitor provided daytime blood pressure measurements that were comparable to those from a traditional ambulatory BP monitor, showing no significant differences in systolic blood pressure.

The Aktiia monitor demonstrated a marginally non-significant bias in diastolic blood pressure, suggesting it may be a reliable alternative for continuous blood pressure monitoring in clinical settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Aktiia cuffless blood pressure monitor yields equivalent daytime blood pressure measurements compared to a 24-h ambulatory blood pressure monitor: Preliminary results from a prospective single-center study. Almeida, TP., Cortés, M., Perruchoud, D., et al.[2023]

A clinical comparison involving 51 veterans showed that the Schiotz tonometer provides comparable intraocular pressure (IOP) measurements to the standard Perkins applanation tonometer, with strong correlation coefficients ranging from +0.68 to +0.85.

The Schiotz tonometer is a more portable and cost-effective alternative for IOP screening, making it a viable option for use in outpatient clinics, nursing homes, and hospitals.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Portable tonometers: a clinical comparison of applanation and indentation devices. Chiara, GF., Semes, LP., Potter, JW., et al.[2006]

The Aktiia initialization oscillometric upper-arm cuff device demonstrated high accuracy in measuring blood pressure, with mean differences of only 1.3 mmHg for systolic and -0.2 mmHg for diastolic pressure compared to a standard mercury sphygmomanometer.

The device meets the ANSI/AAMI/ISO 81060-2:2013 standards for blood pressure monitoring, indicating it is safe and reliable for use in home settings for the general population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Validation of the Aktiia blood pressure cuff for clinical use according to the ANSI/AAMI/ISO 81060-2:2013 protocol. Alexandre, J., Tan, K., Almeida, TP., et al.[2023]

In a study involving 5 eyes with Boston type 1 keratoprosthesis, the Schiotz tonometer provided significantly more accurate intraocular pressure (IOP) measurements compared to the Tono-pen, with lower median absolute errors at both the temporal sclera and corneoscleral limbus.

The findings suggest that clinicians should consider using the Schiotz tonometer for measuring IOP in patients with keratoprosthesis, as it demonstrated higher accuracy compared to the Tono-pen and the gold standard digital manometry.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Schiotz tonometry accurately measures intraocular pressure in Boston type 1 keratoprosthesis eyes. Estrovich, IE., Shen, C., Chu, Y., et al.[2022]

The Icare ic200 tonometer tends to overestimate intraocular pressure (IOP) compared to the Perkins tonometer, especially in patients with IOP greater than 19 mm Hg and those with corneal opacity, based on a study of 194 eyes from 105 pediatric glaucoma patients.

The differences in IOP measurements were more pronounced in eyes with scarred corneas, indicating that corneal clarity and thickness can significantly affect the accuracy of IOP readings between these two devices.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparative Evaluation of Rebound and Perkins Tonometers in Pediatric Glaucoma With Varied Corneal Characteristics. Angmo, D., Ramesh, P., Mahalingam, K., et al.[2023]

The study proposes a new experimental protocol for validating cuffless wrist blood pressure monitors, addressing challenges in real-world settings, such as different body postures and hydrostatic pressure changes.

Testing of the Aktiia Bracelet showed it can accurately estimate blood pressure in sitting and lying positions, indicating its potential for effective home monitoring without the discomfort of traditional cuffs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Are cuffless devices challenged enough? Design of a validation protocol for ambulatory blood pressure monitors at the wrist: the case of the Aktiia Bracelet. Sola, J., Vybornova, A., Fallet, S., et al.[2020]

In a study involving 30 patients with thyroid-associated ophthalmopathy, both the non-contact tonometer (NCT) and the Goldmann applanation tonometer (GAT) provided similar measurements of intraocular pressure (IOP) and mean ocular perfusion pressure (MOPP), indicating that NCT is a reliable alternative for monitoring these parameters.

The diagnostic efficacy of both tonometers was found to be equivalent, with 100% sensitivity and high specificity, suggesting that NCT could be a less invasive option for long-term monitoring in patients with TAO.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of Two Tonometers in the Evaluation of 24-Hour Intraocular Pressure and Mean Ocular Perfusion Pressure in Patients with Thyroid-Associated Ophthalmopathy. Liu, W., Zhou, Y., Hu, X., et al.[2022]

The Aktiia Bracelet, a wearable device, accurately estimates blood pressure (BP) across various common body positions, showing only minor differences compared to traditional auscultatory measurements in a study of 91 patients over 4 weeks.

This technology has the potential to enhance the phenotyping of hypertension in real-life conditions, which could lead to better public health interventions, although further studies are needed to confirm its prognostic value for cardiovascular events.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Validation of the optical Aktiia bracelet in different body positions for the persistent monitoring of blood pressure. Sola, J., Vybornova, A., Fallet, S., et al.[2022]

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Hilo Band

Our clinically validated device measures your blood pressure automatically at the right times – day and night – with no effort required from you.