Pulse Rate and Breathing Rate Accuracy | NCT06298981

Studies
Pulse Rate and Breathing Rate Accuracy

NCT06298981

Sponsor

Nuralogix Corporation

Status

Unknown status

Last Update Posted

Mar 22, 2024Actual

Enrollment

60Estimated

Phase

Not provided

Conditions

Pulse Rate and Breathing Rate

Interventions

noninvasive and investigational NuraLogix AMC-SDK

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 2024

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 12, 2024Actual

Primary Completion Date

Jun 30, 2024Estimated

Completion Date

Jun 30, 2024Estimated

First Submitted Date

Mar 1, 2024

First Submission Date that Met QC Criteria

Mar 1, 2024

First Posted Date

Mar 7, 2024Actual

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 21, 2024

Last Update Posted Date

Mar 22, 2024Actual

Description Module

Brief Summary

The purpose of this study is to conduct a Breathing Rate and Pulse Rate accuracy validation comparing the NuraLogix AMC-SDK to the Reference devices, an FDA cleared End Tidal Carbon Dioxide monitor (GE Datex-Ohmeda) and a standard ECG (GE Datex-Ohmeda) derived heart rate reference. This will be done by manually scoring the collected waveform for data analysis.

Detailed Description

Not provided

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

60Estimated

Name	Type	Description	Arm Group Labels	Other Names
noninvasive and investigational NuraLogix AMC-SDK	Device	The NuraLogix AMC-SDK is a noninvasive device that allows for real-time, remote measuring using facial recordings.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Breathing rate accuracy validation	The purpose of this study is to conduct a Breathing Rate accuracy validation comparing the NuraLogix AMC-SDK to the Reference, an FDA cleared End Tidal Carbon Dioxide monitor (GE Datex-Ohmeda) by manually scoring the collected waveform for data analysis	1-2 hours
Pulse rate accuracy validation	This study will also assess the pulse rate measurements of the NuraLogix AMC-SDK for comparison to a standard ECG (GE Datex-Ohmeda) derived heart rate reference.	1-2 hours

Secondary Outcomes

Measure	Description	Time Frame
Pulse rate simulation	To assess a broader pulse rate range by manipulating the speed of recorded videos.	1-2 hours

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Participants must have the ability to understand and provide written informed consent or have legally authorized representative consent to participate
Participant must be 18 to 81 years of age (≥ 18 age to < 82)
Participant must be willing and able to comply with study procedures and duration
Participants or legally authorized representative must be able to read or write in English

Exclusion Criteria:

Participants who refuse or are unable to provide to sign an informed written consent for study
Participants evaluated by the Investigator and Clinical Staff and found to be medically - unsuitable or have self-reported health conditions that are currently unstable as identified in the Health Assessment Form and Health Screening
Compromised circulation, injury, or physical malformation of fingers, toes, hands, ears or forehead/skull or other sensor Region of Interest (ROI) which would limit the ability to test ROI needed for the study. Tattoo in the optical path which would limit the ability to test ROI needed for the study. (Note: Certain malformations may still allow participants to participate if the condition is noted and would not affect the particular areas utilized.)
Participants with severe contact allergies to standard adhesives, latex or other materials found in pulse oximetry sensors, ECG electrodes, or other medical sensors (self- reported)
Other known health condition, should be considered upon disclosure in health assessment form

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

81 Years

Standard Ages

AdultOlder Adult

Study Population

The study population will be comprised of diversity in race, age, gender, BMI, skin tone, and health conditions. The health conditions will constitute inclusion of healthy controls (to allow testing over the full range of breaths per minute) and disease comorbidities (to represent comorbidities such as COPD, CHF, Asthma, Diabetes, Hypertension, and Obesity). An attempt will be made to enroll a variety of skin tones.

Sampling Method

Non-Probability Sample