Validation of pulse and breathing rate measurement accuracy
Pulse Rate and Breathing Rate Accuracy Study - NuraLogix AMC-SDK
This study is testing if the NuraLogix device can accurately measure pulse and breathing rates compared to trusted medical devices in adults aged 18 to 81.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 60 (estimated) |
| Ages | 18 Years to 81 Years |
| Sex | All |
| Sponsor | Nuralogix Corporation Industry-sponsored |
| Locations | 1 site (Louisville, Colorado) |
| Trial ID | NCT06298981 on ClinicalTrials.gov |
What this trial studies
This study aims to validate the accuracy of pulse and breathing rate measurements using the NuraLogix AMC-SDK by comparing it to established reference devices, including an FDA-cleared End Tidal Carbon Dioxide monitor and a standard ECG-derived heart rate reference. Participants aged 18 to 81 will be involved, and their data will be collected through noninvasive methods. The study will analyze the collected waveform data to assess the performance of the NuraLogix device against the reference standards.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 to 81 who can provide informed consent and comply with study procedures.
Not a fit: Patients with unstable health conditions or those unable to provide informed consent may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance the accuracy of noninvasive monitoring of pulse and breathing rates, leading to better patient care.
How similar studies have performed: While similar studies have explored noninvasive monitoring techniques, the specific approach of this study is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Louisville, Colorado
- Element Materials Technology — Louisville, Colorado, United States (Recruiting)
Study contacts
- Study coordinator: Roberto Liddi
- Email: robertoliddi@nuralogix.ai
- Phone: (647) 578-7925
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.