RECRUITING

Pulse Rate and Breathing Rate Accuracy

Conditions

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Pulse Rate and Breathing Rate Accuracy Study - NuraLogix AMC-SDK

Quick Facts

Study Start:2024-02-12

Study Completion:2024-06-30

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06298981

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 81 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:Yes

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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	* 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

Inclusion Criteria

Exclusion 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

* 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

Contacts and Locations

Study Contact

Roberto Liddi

CONTACT

(647) 578-7925

robertoliddi@nuralogix.ai

Study Locations (Sites)

Element Materials Technology

Louisville, Colorado, 80027

United States

Collaborators and Investigators

Sponsor: Nuralogix Corporation

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-02-12

Study Completion Date2024-06-30

Study Record Updates

Study Start Date2024-02-12

Study Completion Date2024-06-30

Terms related to this study

Additional Relevant MeSH Terms

Pulse Rate and Breathing Rate