Pulse Rate and Breathing Rate Accuracy

Pulse Rate and Breathing Rate Accuracy Study - NuraLogix AMC-SDK

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.

Study Overview

• Status: Recruiting
• Conditions: Pulse Rate and Breathing Rate
• Intervention / Treatment: Device: noninvasive and investigational NuraLogix AMC-SDK

• Study Type: Observational
• Enrollment (Estimated): 60

Contacts and Locations

• Study Contact: Name: Roberto Liddi; Phone Number: (647) 578-7925; Email: robertoliddi@nuralogix.ai

Study Locations

• United States
  • Colorado
    • Louisville, Colorado, United States, 80027
      • Recruiting
      • Element Materials Technology
      • Contact: Monica Rabanal

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

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.

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: Nuralogix Corporation

Study record dates

Study Major Dates

• Study Start (Actual): February 12, 2024
• Primary Completion (Estimated): June 30, 2024
• Study Completion (Estimated): June 30, 2024

Study Registration Dates

• First Submitted: March 1, 2024
• First Submitted That Met QC Criteria: March 1, 2024
• First Posted (Actual): March 7, 2024

Study Record Updates

• Last Update Posted (Actual): March 22, 2024
• Last Update Submitted That Met QC Criteria: March 21, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Respiration Disorders; Respiratory Aspiration
• Other Study ID Numbers: 2301

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: No plan to share IPD

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No