imPulse™ Tor System Self-Directed Cuffless Blood Pressure Monitoring

NCT05386654 | Completed

• 1 other identifier: L42CVP-0005
• Study Type: observational
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

AI-driven, Self-directed Blood Pressure Monitoring

Keywords

infrasound; vibroacoustic; capacitive ECG; electric potential sensor

Outcome Measures

Primary Outcomes (1)

• 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.

  bid/1week

Secondary Outcomes (2)

• imPulse™ Tor Heart Rate Prediction

  bid/1week

• imPulse™ Tor Oxygen Saturation Prediction

  bid/1week

Interventions

imPulse™ Tor System DEVICE

Self-directed blood pressure data capture

Also known as: Clinical reference gold standard sphygmomanometer

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Healthy volunteer healthcare worker cohort

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Level 42 AI, Inc.: lead
• University of California, Davis: collaborator

Study Sites (1)

UCD Sports Medicine

Sacramento, California, 95816, United States

Location

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 18, 2022
• First Posted: May 23, 2022
• Study Start: May 16, 2022
• Primary Completion: August 23, 2022
• Study Completion: August 30, 2022
• Last Updated: March 23, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)