Clinical trial NCT06298981: Pulse Rate and Breathing Rate Accuracy
Official title: Pulse Rate and Breathing Rate Accuracy Study - NuraLogix AMC-SDK
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Pulse Rate and Breathing Rate
Lead sponsor: Nuralogix Corporation
Sponsor class: INDUSTRY
First posted: 2024-03-07
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 81
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
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.

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.


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

Primary outcomes:
measure: Breathing rate accuracy validation
timeFrame: 1-2 hours
measure: Pulse rate accuracy validation
timeFrame: 1-2 hours
Secondary outcomes:
measure: Pulse rate simulation
timeFrame: 1-2 hours
Other outcomes:
Locations:
city: Louisville
country: United States
facility: Element Materials Technology
state: Colorado
Study officials:
References: