Recruiting

Observational Study

Sponsor:

Nuralogix Corporation

Code:

NCT06298981

Conditions

Pulse Rate and Breathing Rate

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

Interventions

noninvasive and investigational NuraLogix AMC-SDK

Study Details

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 ID

NCT06298981

Start date

Feb 12, 2024

Status verified date

Mar, 2024

Completion date

Jun 30, 2024

Anticipated

Primary completion date

Jun 30, 2024

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

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 Design

Enrollment

60 participants

Anticipated

Interventions and Outcome Measures

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.

Primary outcome measure

  • Breathing rate accuracy validation [ Time Frame: 1-2 hours ]
  • Pulse rate accuracy validation [ Time Frame: 1-2 hours ]

Central Contacts and Locations

Central contacts

Roberto Liddi

(647) 578-7925robertoliddi@nuralogix.ai

Locations

Element Materials Technology

Recruiting

Louisville, Colorado, United States, 80027

More Information

Sponsor

Nuralogix Corporation

Last update posted

Mar 22, 2024

Last verified

Mar, 2024

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Nuralogix Corporation on 2024-03-22.