General PopulationNCT06017687
Data Collection and Evaluation of OptiBP Under Investigational Use
A study testing OptiBP Study app in people with General Population, run by Biospectal at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- General Population
- What is being tested?
- OptiBP Study app
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 500,000 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Sep 2023to Sep 2026
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Be at least 18 years old (at least 19 years old in Alabama and Nebraska, at least 21 years old in Puerto Rico);
- Live in the United States of America
- Have an Android smartphone
- Have access to an arm-worn blood pressure monitor (cuff)
- Have access to the Google Play store to download the OptiBP study app on their phone
- Be comfortable communicating in written and spoken English
- Be willing and able to provide informed consent to participate in the study
Who cannot join
- Known contact dermatitis to nickel/chromium
- Lesion or deficiency on hand, preventing placing a finger on the smartphone camera
- Known dysrhythmia like bigeminy, trigeminy, isolated VPB, atrial fibrillation
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Decentralized Trial
Truckee, California, 96161
Frederic Frappereau, 650-229-8604, study@biospectal.com
About this study
Official title: Data Collection and Evaluation of a Mobile, Machine-learning-based Solution for Blood Pressure Estimation - the OptiBP Study.
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.
Read the detailed description
Participants will simultaneously acquire blood pressure measurements through a cuff-based, automatic, over-the-counter blood pressure monitor on the upper arm, while recording an optical signal through the camera of a smartphone on the tip of the index of the opposite arm.
- Conditions
- General Population
- Being tested
- OptiBP Study app
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OptiBP Study appDevice
Each participant will use OptiBP Study app to measure their blood pressure optically by applying their fingertip to their smartphone camera, and subsequently enter the blood pressure values obtained by measuring it with their own blood pressure cuff.
| Study group | Role | What they receive |
|---|---|---|
| Principal Arm | Other | Each participant will use the OptiBP Study app on their smartphone Receives: Device: OptiBP Study app |
What is being measured
The primary outcome is the main question the study is designed to answer.
Collect Blood Pressure (BP) data and assess performance of smartphone based BP estimations models
To collect data to train a machine-learning based solution for estimating blood pressure. Participants will simultaneously acquire blood pressure measurements through a cuff-based, automatic, over-the-counter blood pressure monitor at the upper arm, while recording an optical signal through the camera of a smartphone on the tip of the index of the opposite arm. The performance of the machine learning model will be assessed by calculating the mean and standard deviation of the error of blood pressure estimations versus cuff-based, automatic, over-the-counter blood pressure monitors.
Measured: 12 months
Secondary outcomes (1)
Safety by assessing inconvenience and adverse events
To identify potential use errors of an app that use the machine-learning model to estimate blood pressure. And to assess safety of the intervention.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2023
- Study start28 Sep 2023
- Primary completionSep 2024 (estimated)
- Study completionSep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for General PopulationStudies 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
- 500,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Biospectal
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Frederic Frappereau, Principal investigator, Biospectal
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06017687
- Sponsor's protocol ID
- US Data Collection Study
- Status last verified
- Sep 2023
- First submitted
- 24 Aug 2023
- Last updated
- 29 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: The data is anonymized and used for machine learning training
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Data Collection and Evaluation of a Mobile, Machine-learning-based Solution for Blood Pressure Estimation - the OptiBP Study.
- ClinicalTrials.gov ID
- NCT06017687
- Acronym / sponsor ID
- US Data Collection Study
- Conditions
- General Population
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 500,000 participants (estimated)
- Lead sponsor
- BiospectalIndustry (pharma, biotech, devices)
- Study start
- 28 Sep 2023 (actual)
- Primary completion
- Sep 2024 (estimated)
- Study completion
- Sep 2026 (estimated)
- First posted
- 30 Aug 2023 (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.
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.
Detailed description
Participants will simultaneously acquire blood pressure measurements through a cuff-based, automatic, over-the-counter blood pressure monitor on the upper arm, while recording an optical signal through the camera of a smartphone on the tip of the index of the opposite arm.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Principal Arm | Other | Device: OptiBP Study appEach participant will use the OptiBP Study app on their smartphone |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Be at least 18 years old (at least 19 years old in Alabama and Nebraska, at least 21 years old in Puerto Rico);
- Live in the United States of America
- Have an Android smartphone
- Have access to an arm-worn blood pressure monitor (cuff)
- Have access to the Google Play store to download the OptiBP study app on their phone
Key exclusion criteria (3 listed)
- Known contact dermatitis to nickel/chromium
- Lesion or deficiency on hand, preventing placing a finger on the smartphone camera
- Known dysrhythmia like bigeminy, trigeminy, isolated VPB, 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 |
|---|---|---|
| OptiBP Study appEach participant will use OptiBP Study app to measure their blood pressure optically by applying their fingertip to their smartphone camera, and subsequently enter the blood pressure values obtained by measuring it with their own blood pressure cuff. | Device | Principal Arm |
Primary outcome
Collect Blood Pressure (BP) data and assess performance of smartphone based BP estimations models
Time frame: 12 months
To collect data to train a machine-learning based solution for estimating blood pressure. Participants will simultaneously acquire blood pressure measurements through a cuff-based, automatic, over-the-counter blood pressure monitor at the upper arm, while recording an optical signal through the camera of a smartphone on the tip of the index of the opposite arm. The performance of the machine learning model will be assessed by calculating the mean and standard deviation of the error of blood pressure estimations versus cuff-based, automatic, over-the-counter blood pressure monitors.
1 secondary outcome
Safety by assessing inconvenience and adverse events
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2023.
- Individual participant dataSharing planned: No. The data is anonymized and used for machine learning training
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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.
Frederic Frappereau principal investigator
Biospectal
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing OptiBP Study app in people with General Population, run by Biospectal 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 7 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 29 Sep 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Frederic Frappereau (650-229-8604, study@biospectal.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Collect Blood Pressure (BP) data and assess performance of smartphone based BP estimations models (time frame: 12 months). 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 29 Sep 2023.