Skip to main content
OpenTrials
Completed

NCT Number: NCT05462886

Clinical Performance of Masimo INVSENSOR00057 for Heart Rate Measurements

This study is designed to compare the accuracy of a noninvasive measurement of heart rate compared to reference values obtained by a standard of care ECG monitor.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Healthy

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Masimo Corporation

Irvine, California, 92618, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Subject is 18 to 80 years of age.
  • Subject is able to read and communicate in English.

Exclusion criteria

  • Subject has open wounds, inflamed tattoos or piercings on the area of device placement, and/or has any visible healing wounds that the investigator and/or medical professional determines may place them at an increased risk for participation.
  • Subject has any medical condition which in the judgment of the investigator and/or study staff, renders them ineligible for participation in this study or subject is deemed ineligible by the discretion of the investigator/study staff.

Treatment and study plan

Masimo INVSENSOR00057

Device

Noninvasive wearable health monitoring device

Primary outcomes

  1. Heart Rate Accuracy of Masimo INVSENSOR00057

    Time frame: 1-3 hours

    Heart rate accuracy was determined by calculating the accuracy root mean-squared (Arms) difference between the measured values from Masimo INVSENSOR00057 (TestHR_i) to the reference ECG monitor values (RefHR_i).

    Arms= √(∑(i=1 to n) ((TestHR_i-RefHR_i )^2 ))/n

Sponsors and collaborators

Lead sponsor

Masimo Corporation

Industry

Registry information

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Jul 18, 2022
Registry last updated
Sep 24, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.