200 Participants NeededMy employer runs this trial

Blood Pressure Monitoring Device for Hypertension

(OBPM_PANDA2026 Trial)

AF
Overseen ByAnne Fedor Chief Clinical Research Officer
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new device that monitors blood pressure and pulse rate to assess its accuracy over a week. The device, called the Aktiia Periodic Optical Blood Pressure Monitoring Device, aids in managing hypertension. The trial seeks participants with high blood pressure who can adhere to study procedures, such as attending follow-up visits. Participants should not have circulation problems, certain heart conditions, or be taking blood thinners. The study aims to ensure the device functions well for a diverse group of people. As an unphased trial, it offers participants the chance to contribute to innovative research that could enhance hypertension management for many.

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

The trial information does not specify whether you need to stop taking your current medications. However, if you are taking prescription blood thinners, you may not be eligible to participate.

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

Research has shown that the Aktiia Periodic Optical Blood Pressure Monitoring Device is generally safe. Studies have found that it measures blood pressure accurately and precisely, similar to traditional blood pressure cuffs, without causing harm. As a non-invasive device, it typically results in fewer side effects. No major problems have been reported with this device. It also carries a CE mark, indicating compliance with European safety standards, further confirming its safety.12345

Why are researchers excited about this trial?

Researchers are excited about the Aktiia Periodic Optical Blood Pressure Monitoring Device because it offers a unique, non-invasive way to continuously monitor blood pressure. Unlike traditional methods that require a cuff to measure blood pressure at specific intervals, this device uses optical sensors to provide ongoing data throughout the day. This continuous monitoring can lead to more accurate and comprehensive insights into a patient's blood pressure patterns, which is crucial for effectively managing hypertension.

What evidence suggests that this device is effective for monitoring blood pressure in hypertension?

Research has shown that the Aktiia Periodic Optical Blood Pressure Monitoring Device, used by participants in this trial, provides accurate blood pressure readings. Studies have found its results comparable to traditional cuff-based methods. For example, one study found it matches the readings of a 24-hour blood pressure monitor, a standard tool for continuous monitoring. Another study demonstrated its effectiveness for older adults, with results similar to those obtained by listening to heart sounds. Users report high satisfaction with the device and prefer it over traditional cuffs. Overall, the Aktiia device reliably tracks blood pressure.25678

Are You a Good Fit for This Trial?

This trial is for adults aged 22 to 59 who can read or write in English, are able to give consent, and can attend three study visits over one week. Participants must be willing to follow all study procedures.

Inclusion Criteria

1. Participants must be able to provide informed consent to participate.
I am able and willing to follow all study procedures and return for a follow-up visit in one week.
I am between 22 and 59 years old.
See 2 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1 week

Treatment

Participants use the Aktiia.product-G1-US device for blood pressure and pulse rate monitoring

7 days
3 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after device use

1 week

What Are the Treatments Tested in This Trial?

Interventions

  • Aktiia Periodic Optical Blood Pressure Monitoring Device

Trial Overview

The study is testing the accuracy and safety of the Aktiia optical blood pressure monitoring device by comparing its readings with standard reference devices over a period of up to seven days.

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: Aktiia.product-G1-US device under testExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Aktiia SA

Lead Sponsor

Trials
12
Recruited
23,600+

Citations

Blood pressure from the optical Aktiia Bracelet - PMC - NIH

Aktiia Bracelet can be safely and effectively used for noninvasive, self-triggered, intermittent SBP and DBP monitoring in adult patients when the user is ...

Evaluation of Aktiia cuffless blood pressure monitor across 24 ...

These results demonstrate that the Aktiia monitor yields BP measurements consistent with an ABPM monitor despite some systematic differences during night-time ...

3.

healthcare.aktiia.com

healthcare.aktiia.com/evidence/

Evidence - Aktiia Healthcare

Aktiia demonstrates validated accuracy. Aktiia's pivotal trial has proven Aktiia is as accurate as a cuff.

Aktiia cuffless blood pressure monitor yields equivalent ...

The results suggest that 1-week Aktiia monitor yields equivalent daytime BP values to those obtained via 24-h ABPM, which supports the use of Aktiia monitor for ...

Performance of the Aktiia optical blood pressure measurement ...

The study concluded that the Aktiia optical blood pressure (BP) monitor, performs comparably to traditional methods in an elderly population ...

Study Details | NCT07507903 | OBPM_PANDA2026: ...

This study, with N = 85 participants minimum over 3 visits spread over 7 days, has been designed to assess the accuracy and precision of the Blood Pressure and ...

Bracelet G1 EN – User Manual ENGLISH

Aktiia Bracelet G1 is a non-invasive blood pressure (BP) monitor intended to measure optical Photoplethysmography (PPG) signals on the user's wrist and to.

Aktiia Bracelet G1 User Manual

Aktiia Bracelet is the smart way to track your Blood Pressure over days and nights without any effort. Aktiia Bracelet is designed to be discreet, with.