NCT05386654

imPulse™ Tor System Self-Directed Cuffless Blood Pressure Monitoring

AI/ML Algorithm Training and Validation for the imPulse™ Tor System Self-Directed Systolic & Diastolic Blood Pressure Monitor.

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 15 (actual)
• Sponsor: Level 42 AI, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• AI-driven, Self-directed Blood Pressure Monitoring

Interventions

Type	Name	Description
DEVICE	imPulse™ Tor System	Self-directed blood pressure data capture

Timeline

• Start date: 2022-05-16
• Primary completion: 2022-08-23
• Completion: 2022-08-30
• First posted: 2022-05-23
• Last updated: 2023-03-23

Locations

1 site across 1 country: United States