Clinical trial NCT05386654: imPulse™ Tor System Self-Directed Cuffless Blood Pressure Monitoring
Official title: AI/ML Algorithm Training and Validation for the imPulse™ Tor System Self-Directed Systolic & Diastolic Blood Pressure Monitor.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: AI-driven, Self-directed Blood Pressure Monitoring
Keywords: infrasound
vibroacoustic
capacitive ECG
electric potential sensor
Lead sponsor: Level 42 AI, Inc.
Sponsor class: INDUSTRY
Collaborators: name: University of California, Davis
First posted: 2022-05-23
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Healthy volunteer healthcare worker cohort

Brief 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 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.

Eligibility criteria: Inclusion Criteria:

• Participants are limited to clinical staff and first-responders who work at the UC Davis C Street Clinics in the Sports and Spine suites.

Exclusion Criteria:

* 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

Primary outcomes:
measure: imPulse™ Tor System Blood Pressure Prediction
timeFrame: bid/1week
Secondary outcomes:
measure: imPulse™ Tor Heart Rate Prediction
timeFrame: bid/1week
measure: imPulse™ Tor Oxygen Saturation Prediction
timeFrame: bid/1week
Other outcomes:
Locations:
city: Sacramento
country: United States
facility: UCD Sports Medicine
state: California
Study officials:
References: