Smartphone App Monitoring for Blood Pressure Management

Overseen By Frederic Frappereau

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Biospectal

Disqualifiers: Contact dermatitis, Hand lesion, Dysrhythmia

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: Unknown

500000 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a smartphone app designed to manage blood pressure using advanced technology. The main goal is to determine if the OptiBP Study app can accurately estimate blood pressure levels through a phone. It is ideal for U.S. residents who have an Android phone, access to a blood pressure cuff, and are comfortable with English. Those with a smartphone interested in improving blood pressure monitoring may find this a great fit. As an unphased study, this trial offers a unique opportunity to contribute to innovative research in blood pressure management technology.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that the OptiBP Study app is safe for blood pressure management?

Research has shown that the OptiBP app is generally safe for use on smartphones. This app measures blood pressure using the phone's camera and a fingertip. Although most studies have focused on its accuracy rather than safety, no reports of harm or side effects have emerged from using the app. The app's medical certification further supports its safety. While direct safety data is lacking, the absence of reported issues suggests users have tolerated it well so far. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the OptiBP Study app because it offers a new way to manage blood pressure using something as simple as a smartphone. Unlike traditional methods that rely on regular doctor visits or home blood pressure monitors, this app provides continuous monitoring and feedback right in the palm of your hand. This can empower users to take a more active role in managing their health and potentially catch issues earlier. The convenience and accessibility of using an app could lead to better adherence to blood pressure management, making this approach a game-changer for many people.

What evidence suggests that the OptiBP app is effective for blood pressure management?

Research has shown that the OptiBP smartphone app, which participants in this trial will use, accurately measures blood pressure. One study demonstrated this by comparing the app's readings with those from standard devices in 40 patients. Another study confirmed the app's accuracy by testing it against traditional blood pressure methods. The app estimates blood pressure using a light signal from a fingertip, making it a convenient tool for monitoring heart health. These findings suggest the app could effectively help manage blood pressure. ^{3 4 6 7 8}

Who Is on the Research Team?

Frederic Frappereau

Principal Investigator

Biospectal

Are You a Good Fit for This Trial?

This trial is for adults living in the USA who have an Android smartphone, access to a blood pressure cuff, and can download the OptiBP app. They must be comfortable with English and able to consent. Excluded are those with certain heart rhythm disorders or skin reactions to metals, or hand lesions.

Inclusion Criteria

I am of legal age as required by my location to participate.

Live in the United States of America

Have access to an arm-worn blood pressure monitor (cuff)

Exclusion Criteria

You have a known allergic reaction to nickel or chromium that causes skin irritation.

I have a known irregular heartbeat condition.

I cannot place a finger on my smartphone camera due to a hand issue.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Data Collection

Participants will use the OptiBP Study app to collect blood pressure data using a smartphone and a cuff-based monitor

12 months

Regular data collection sessions

Follow-up

Participants are monitored for safety and effectiveness after data collection

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• OptiBP Study app

Trial Overview

The study is testing the OptiBP mobile app that uses machine learning to estimate blood pressure. Participants will use their own smartphones and arm-worn blood pressure monitors as part of data collection for app evaluation.

How Is the Trial Designed?

Group I: Principal Arm Experimental Treatment 1 Intervention

Each participant will use the OptiBP Study app on their smartphone

Who Is Running the Clinical Trial?

Biospectal

Lead Sponsor

Trials

2

Recruited

500,000+

Published Research Related to This Trial

A randomized clinical trial involving 2101 participants found that enhanced self-measured blood pressure (SMBP) using a smartphone application did not significantly reduce blood pressure more than standard SMBP methods over 6 months.

Both enhanced and standard SMBP methods showed similar levels of patient satisfaction, with around 70% of participants likely to recommend their devices, indicating that the added technology did not improve outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of Standard vs Enhanced Self-measurement of Blood Pressure Paired With a Connected Smartphone Application: A Randomized Clinical Trial. Pletcher, MJ., Fontil, V., Modrow, MF., et al.[2023]

Automated office blood pressure (AOBP) measurement is a reliable alternative to 24-hour ambulatory blood pressure monitoring (ABPM) and home blood pressure measurements in hypertensive patients, based on a study of 123 patients.

The study found that AOBP measurements showed similar results to ABPM and home BP, suggesting that AOBP can be used effectively for routine blood pressure evaluations when ABPM is not available.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[PASTIS study: Evaluation of an automated office blood pressure measurement]. Ayach, O., Sarlon Bartoli, G., Silhol, F., et al.[2022]

The OptiBP smartphone app can accurately measure blood pressure (BP) at the fingertip, with results closely aligning with traditional auscultatory methods, meeting ISO standards for accuracy.

This technology could significantly enhance hypertension detection and management, especially in low-income countries where smartphone access is widespread but healthcare resources are limited.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Blood pressure measurements with the OptiBP smartphone app validated against reference auscultatory measurements. Schoettker, P., Degott, J., Hofmann, G., et al.[2021]

The study involved 172 participants (78 men and 94 women) using a smartphone app for telemonitoring blood pressure, but the overall proportion of those achieving controlled blood pressure levels did not significantly increase after 3 months.

However, participants with initially uncontrolled blood pressure experienced a significant reduction in their levels, dropping from an average of 138.0/91.3 mmHg to 133.4/88.6 mmHg, indicating that the telemonitoring approach effectively lowered blood pressure in this group.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A pilot study of hypertension management using a telemedicine treatment approach. Wijkman, M., Carlsson, M., Darwiche, G., et al.[2021]

The MeasureBP study group is working to establish evidence-based equivalences between automated blood pressure measurement (BPM) and standardized manual measurements, addressing a significant gap in hypertension management.

By synthesizing existing research and conducting meta-analyses, the study aims to provide clear treatment targets and thresholds for automated BPM, which could enhance the effectiveness of hypertension guidelines.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

MEthods of ASsessing blood pressUre: identifying thReshold and target valuEs (MeasureBP): a review & study protocol. Blom, KC., Farina, S., Gomez, YH., et al.[2018]

A smartphone app called OptiBP was tested on 121 patients undergoing general anesthesia, showing over 90% concordance with invasive blood pressure measurements, indicating its potential for accurate hypertension screening in dynamic conditions.

The app demonstrated high accuracy with a bias of only 0.0 mmHg for systolic blood pressure, suggesting it could be a reliable tool for blood pressure monitoring, especially in settings with limited healthcare resources.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A novel smartphone app for blood pressure measurement: a proof-of-concept study against an arterial catheter. Hofmann, G., Proença, M., Degott, J., et al.[2023]

The OptiBP mobile application, which estimates blood pressure using a smartphone camera, demonstrated high accuracy in a study of 91 participants, meeting the validation standards set by AAMI, ESH, and ISO.

With an acceptance rate of 85%, the app showed a mean difference of only 0.5 mmHg for systolic blood pressure (SBP) and 0.4 mmHg for diastolic blood pressure (DBP) compared to traditional auscultatory measurements, indicating its potential as a reliable tool for blood pressure monitoring.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Smartphone based blood pressure measurement: accuracy of the OptiBP mobile application according to the AAMI/ESH/ISO universal validation protocol. Degott, J., Ghajarzadeh-Wurzner, A., Hofmann, G., et al.[2023]

The OptiBP™ smartphone application showed good agreement with invasive blood pressure measurements in ICU patients, with mean differences within acceptable limits for mean arterial pressure and diastolic pressure, fulfilling AAMI/ISO standards.

Out of 30 patients, 22 provided adequate measurements, and the majority of readings (over 97%) were classified as low risk, indicating that the smartphone app could be a reliable tool for blood pressure monitoring.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of a novel optical smartphone blood pressure application: a method comparison study against invasive arterial blood pressure monitoring in intensive care unit patients. Desebbe, O., Anas, C., Alexander, B., et al.[2022]

In a pilot study involving 110 patients in the emergency department, the new smartphone application OptiBP™ showed moderate agreement with the standard automated oscillometric method for measuring blood pressure, with mean differences close to zero for systolic, diastolic, and mean arterial pressures.

After initial calibration, 100% of the measurement differences between OptiBP™ and the reference method were classified as low-risk for treatment decisions, indicating that OptiBP™ could be a safe alternative for blood pressure monitoring in clinical settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of a novel mobile phone application for blood pressure monitoring: a proof of concept study. Desebbe, O., Tighenifi, A., Jacobs, A., et al.[2022]

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