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

Trial Summary

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 data supports the effectiveness of the OptiBP app treatment for blood pressure management?

Research shows that the OptiBP app can accurately measure blood pressure using a smartphone camera, similar to traditional methods. This suggests it could be a useful tool for monitoring blood pressure at home, making it easier for people to keep track of their health. ^{1 2 3 4 5}

Is the OptiBP app safe for monitoring blood pressure in humans?

The OptiBP app has been tested in various studies, including in emergency department and intensive care unit patients, and has shown moderate agreement with standard blood pressure measurement methods. The studies indicate that the app's use is associated with no- or low-risk treatment decisions, suggesting it is generally safe for monitoring blood pressure in humans. ^{1 3 5 6 7}

How does the smartphone app treatment for blood pressure management differ from other treatments?

The smartphone app treatment for blood pressure management is unique because it allows users to measure their blood pressure using their smartphone's camera by placing their fingertip on it, providing a convenient and accessible way to monitor blood pressure without the need for traditional cuffs or medical equipment. This method can be particularly beneficial in areas with limited healthcare resources, offering a scalable solution for hypertension screening and management. ^{1 5 6 8 9}

What is the purpose of this trial?

The purpose of this study is to collect data to develop and evaluate the use of state-of-the-art machine learning approaches within a mobile phone application for the estimation of blood pressure.

Research Team

Frederic Frappereau

Principal Investigator

Biospectal

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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 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]

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 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]

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 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]

References

1. England 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. [2023]

2. England pubmed.ncbi.nlm.nih.gov

A pilot study of hypertension management using a telemedicine treatment approach. [2021]

3. United States 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. [2023]

4. France pubmed.ncbi.nlm.nih.gov

[PASTIS study: Evaluation of an automated office blood pressure measurement]. [2022]

5. England 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. [2022]

6. Netherlands pubmed.ncbi.nlm.nih.gov

Evaluation of a novel mobile phone application for blood pressure monitoring: a proof of concept study. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

MEthods of ASsessing blood pressUre: identifying thReshold and target valuEs (MeasureBP): a review & study protocol. [2018]

8. Netherlands pubmed.ncbi.nlm.nih.gov

A novel smartphone app for blood pressure measurement: a proof-of-concept study against an arterial catheter. [2023]

9. England pubmed.ncbi.nlm.nih.gov

Blood pressure measurements with the OptiBP smartphone app validated against reference auscultatory measurements. [2021]