Pulse Rate and Breathing Rate
Conditions
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.
Interventions
DEVICEnoninvasive and investigational NuraLogix AMC-SDK
The NuraLogix AMC-SDK is a noninvasive device that allows for real-time, remote measuring using facial recordings.
Sponsors
Nuralogix Corporation
Study design
Observational model
COHORT
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
ALL
Age
18 Years to 81 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Breathing rate accuracy validation | 1-2 hours | 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 |
| Pulse rate accuracy validation | 1-2 hours | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pulse rate simulation | 1-2 hours | To assess a broader pulse rate range by manipulating the speed of recorded videos. |
Countries
United States
Contacts
Primary ContactRoberto Liddi
Outcome results
None listed