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imPulse™ Tor System Self-Directed Cuffless Blood Pressure Monitoring

NCT05386654 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 15

Last updated 2023-03-23

No results posted yet for this study

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

Interventions

DEVICE

imPulse™ Tor System

Self-directed blood pressure data capture

Sponsors & Collaborators

  • University of California, Davis

    collaborator OTHER

  • Level 42 AI, Inc.

    lead INDUSTRY

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-05-16
Primary Completion
2022-08-23
Completion
2022-08-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05386654 on ClinicalTrials.gov