Pulse Rate and Breathing Rate Accuracy

NCT ID: NCT06298981

Last Updated: 2024-03-22

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 60 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-02-12
• Study Completion Date: 2024-06-30

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.

Conditions

Pulse Rate and Breathing Rate

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: CROSS_SECTIONAL

Interventions

noninvasive and investigational NuraLogix AMC-SDK

The NuraLogix AMC-SDK is a noninvasive device that allows for real-time, remote measuring using facial recordings.

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 81 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Nuralogix Corporation

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Element Materials Technology

Louisville, Colorado, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Roberto Liddi

Role: CONTACT

robertoliddi@nuralogix.ai

(647) 578-7925

Facility Contacts

Monica Rabanal

Role: primary

Other Identifiers

2301

Identifier Type: -

Identifier Source: org_study_id