AI-driven, Self-directed Blood Pressure MonitoringNCT05386654
imPulse™ Tor System Self-Directed Cuffless Blood Pressure Monitoring
An observational study of AI-driven, Self-directed Blood Pressure Monitoring, run by Level 42 AI, Inc. at 1 site in United States.
Trial summary
Self-measured, non-invasive accurate blood pressure monitoring continues to be a major challenge for automated vital sign measurement systems. The general notion is that with reliable, self-administered BP monitoring in the clinic and at home, health care providers will be able to diagnose hypertension among… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- AI-driven, Self-directed Blood Pressure Monitoring
- What is being tested?
- imPulse™ Tor System
- Type of treatment
- Medical device
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- 16 May 2022to 30 Aug 2022
- Phase
- Observational
- 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
Study population: Healthy volunteer healthcare worker cohort
Who may be able to join
- Participants are limited to clinical staff and first-responders who work at the UC Davis C Street Clinics in the Sports and Spine suites.
Who cannot join
- History of major neck surgeries
- Unable to sit and stand upright comfortably for 2 minutes
- Unable to obtain or has contraindication to upper extremity blood pressure reading
- Unable to perform self-measurements using the imPulse™ Tor device
- Adults unable to consent
- Individuals who are not yet adults (infants, children, teenagers)
- Pregnant women
Trial locations and contacts
1 site in 1 country.
About this study
Official title: AI/ML Algorithm Training and Validation for the imPulse™ Tor System Self-Directed Systolic & Diastolic Blood Pressure Monitor.
Self-measured, non-invasive accurate blood pressure monitoring continues to be a major challenge for automated vital sign measurement systems. The general notion is that with reliable, self-administered BP monitoring in the clinic and at home, health care providers will be able to diagnose hypertension among individuals at an early stage, including high risk patients in the community, and more quickly assess if prescribed treatment plans are working. The imPulse™ Tor System detects 1) audible and inaudible low-frequency, low-amplitude sounds generated by the body, including arterial pulse waveforms, and 2) ECG-derived heart cycle identification, which can be combined with the vibroacoustic data to estimate blood pressure. The imPulse™ Tor has undergone preliminary testing. In this pilot study, we collect data from health care workers for algorithm training and validation study to achieve medical grade device AAMI/ISO and IEEE standards compliance.
Read the detailed description
Hypertension (HTN) is a major risk factor for cerebrovascular morbidity and mortality, yet its identification can be delayed due to lack of overt symptoms, relying on Blood Pressure (BP) measurements for diagnosis. Several BP monitoring techniques are used in clinics and hospitals, and there is also an outpatient method that is used for 24-hour BP monitoring, based on a sphygmomanometer. The general notion is that with frequent, reliable, self-directed BP monitoring in the clinic and at home, health care providers will be able to diagnose hypertension among individuals at an early stage, including high-risk patients in the community, and more quickly assess if prescribed treatment plans are working. However, non-invasive self-administered blood pressure monitoring continues to be a major challenge for automated vital sign measurement systems.
To circumvent the limitations of current systems of interval hemodynamic measurement and increasing demands on healthcare providers, a non-invasive automated self- directed vital sign monitor that can integrate into hospital early warning systems and warn healthcare providers of deteriorating vital sign parameters would be of significant value. This study aims to provide proof of concept for a portable device that measures vital signs (blood pressure, heart rate, and blood oxygen saturation) using biophysical pneumatics and hydraulics, vibroacoustics, and multi-lead ECG that aims to produce results that are as good as a sphygmomanometer-based device and pulse oximeter, without the need for a circumferential pressure device/sphygmomanometer on the arm.
- Being tested
- imPulse™ Tor System
- Keywords
- infrasound, vibroacoustic, capacitive ECG, electric potential sensor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
imPulse™ Tor SystemDevice
Also called Clinical reference gold standard sphygmomanometer
Self-directed blood pressure data capture
What is being measured
The primary outcome is the main question the study is designed to answer.
imPulse™ Tor System Blood Pressure Prediction
Following AI/ML algorithm training and validation the difference between predicted systolic, diastolic, and mean arterial pressure predictions of the imPulse™ Tor and gold-standard measurement of an electronic blood pressure cuff will be less than 2.5 mmHg in at least 90% of the measurements, less than 5 mmHg in at least 92.5% of the measurements and less than 10 mmHg in at least 95% of the measurements.
Measured: bid/1week
Secondary outcomes (2)
imPulse™ Tor Heart Rate Prediction
Following AI/ML algorithm training and validation, there is no significant difference (p-values >0.05) in the comparisons of electronic blood pressure cuff pulse measurement and imPulse™ Tor estimations for HR measurements (BPM).
Measured: bid/1week
imPulse™ Tor Oxygen Saturation Prediction
Following AI/ML algorithm training and validation, the imPulse™ Tor can predict oxygen saturation (a proposed fifth vital sign) with an overall classification accuracy > 85% for the SpO2 class "< 84%", "85 to 91%" and "> 92%", respectively.
Measured: bid/1week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2022
- Study start16 May 2022
- Primary completion23 Aug 2022
- Study completion30 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AI-driven, Self-directed Blood Pressure MonitoringStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Level 42 AI, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University of California, Davis
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05386654
- Sponsor's protocol ID
- L42CVP-0005
- Status last verified
- Mar 2023
- First submitted
- 18 May 2022
- Last updated
- 23 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Pilot study data for algorithm training using different AI/ML approaches.
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- AI/ML Algorithm Training and Validation for the imPulse™ Tor System Self-Directed Systolic & Diastolic Blood Pressure Monitor.
- ClinicalTrials.gov ID
- NCT05386654
- Acronym / sponsor ID
- L42CVP-0005
- Keywords
- infrasound, vibroacoustic, capacitive ECG, electric potential sensor
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Level 42 AI, Inc.Industry (pharma, biotech, devices)
- Collaborators
- University of California, Davis
- Study start
- 16 May 2022 (actual)
- Primary completion
- 23 Aug 2022 (actual)
- Study completion
- 30 Aug 2022 (actual)
- First posted
- 23 May 2022 (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.
Self-measured, non-invasive accurate blood pressure monitoring continues to be a major challenge for automated vital sign measurement systems. The general notion is that with reliable, self-administered BP monitoring in the clinic and at home, health care providers will be able to diagnose hypertension among individuals at an early stage, including high risk patients in the community, and more quickly assess if prescribed treatment plans are working. The imPulse™ Tor System detects 1) audible and inaudible low-frequency, low-amplitude sounds generated by the body, including arterial pulse waveforms, and 2) ECG-derived heart cycle identification, which can be combined with the vibroacoustic data to estimate blood pressure. The imPulse™ Tor has undergone preliminary testing. In this pilot study, we collect data from health care workers for algorithm training and validation study to achieve medical grade device AAMI/ISO and IEEE standards compliance.
Detailed description
Hypertension (HTN) is a major risk factor for cerebrovascular morbidity and mortality, yet its identification can be delayed due to lack of overt symptoms, relying on Blood Pressure (BP) measurements for diagnosis. Several BP monitoring techniques are used in clinics and hospitals, and there is also an outpatient method that is used for 24-hour BP monitoring, based on a sphygmomanometer. The general notion is that with frequent, reliable, self-directed BP monitoring in the clinic and at home, health care providers will be able to diagnose hypertension among individuals at an early stage, including high-risk patients in the community, and more quickly assess if prescribed treatment plans are working. However, non-invasive self-administered blood pressure monitoring continues to be a major challenge for automated vital sign measurement systems.
To circumvent the limitations of current systems of interval hemodynamic measurement and increasing demands on healthcare providers, a non-invasive automated self- directed vital sign monitor that can integrate into hospital early warning systems and warn healthcare providers of deteriorating vital sign parameters would be of significant value. This study aims to provide proof of concept for a portable device that measures vital signs (blood pressure, heart rate, and blood oxygen saturation) using biophysical pneumatics and hydraulics, vibroacoustics, and multi-lead ECG that aims to produce results that are as good as a sphygmomanometer-based device and pulse oximeter, without the need for a circumferential pressure device/sphygmomanometer on the arm.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Healthy volunteer healthcare worker cohort
Key inclusion criteria (1 listed)
- Participants are limited to clinical staff and first-responders who work at the UC Davis C Street Clinics in the Sports and Spine suites.
Key exclusion criteria (7 listed)
- History of major neck surgeries
- Unable to sit and stand upright comfortably for 2 minutes
- Unable to obtain or has contraindication to upper extremity blood pressure reading
- Unable to perform self-measurements using the imPulse™ Tor device
- Adults unable to consent
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 |
|---|---|---|
| imPulse™ Tor SystemAlso: Clinical reference gold standard sphygmomanometerSelf-directed blood pressure data capture | Device | – |
Primary outcome
imPulse™ Tor System Blood Pressure Prediction
Time frame: bid/1week
Following AI/ML algorithm training and validation the difference between predicted systolic, diastolic, and mean arterial pressure predictions of the imPulse™ Tor and gold-standard measurement of an electronic blood pressure cuff will be less than 2.5 mmHg in at least 90% of the measurements, less than 5 mmHg in at least 92.5% of the measurements and less than 10 mmHg in at least 95% of the measurements.
2 secondary outcomes
imPulse™ Tor Heart Rate Prediction
Time frame: bid/1week
imPulse™ Tor Oxygen Saturation Prediction
Time frame: bid/1week
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2023.
- Individual participant dataSharing planned: No. Pilot study data for algorithm training using different AI/ML approaches.
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of AI-driven, Self-directed Blood Pressure Monitoring, run by Level 42 AI, Inc. 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 1 inclusion and 7 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: finished, as of the sponsor's last update on 23 Mar 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
imPulse™ Tor System Blood Pressure Prediction (time frame: bid/1week). 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 23 Mar 2023.