imPulse™ Tor System Self-Directed Cuffless Blood Pressure... | NCT05386654

Studies
imPulse™ Tor System Self-Directed Cuffless Blood Pressure Monitoring

NCT05386654

Sponsor

Level 42 AI, Inc.

Status

Completed

Last Update Posted

Mar 23, 2023Actual

Enrollment

15Actual

Phase

Not provided

Conditions

AI-driven, Self-directed Blood Pressure Monitoring

Interventions

imPulse™ Tor System

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2023

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 16, 2022Actual

Primary Completion Date

Aug 23, 2022Actual

Completion Date

Aug 30, 2022Actual

First Submitted Date

May 18, 2022

First Submission Date that Met QC Criteria

May 18, 2022

First Posted Date

May 23, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 22, 2023

Last Update Posted Date

Mar 23, 2023Actual

Name	Class
University of California, Davis	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

15Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
imPulse™ Tor System	Device	Self-directed blood pressure data capture		Clinical reference gold standard sphygmomanometer

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
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).	bid/1week
imPulse™ Tor Oxygen Saturation Prediction

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Healthy volunteer healthcare worker cohort

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
UCD Sports Medicine		Sacramento	California	95816	United States

IPD Sharing Statement Module

Plan to Share IPD

Description

Pilot study data for algorithm training using different AI/ML approaches.

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided