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OpenTrials
Active, Not Recruiting

NCT Number: NCT06696339

Assessment of Heart Rate Measurement Accuracy for the PreemptiveAI SDK in Adults

The goal of this clinical trial is to assess the accuracy of the PreemptiveAI SDK to measure heart rate for adults as compared to an FDA-approved ground truth device.

Participants will:

* Complete a demographics and health history survey * Apply and wear ground truth equipment such as a pulse oximeter and ECG * Measure their heart rate 8 times with 4 different smartphones using the PreemptiveAI SDK

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Heart Rate in the General Public

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Paul Allen Institute for Artificial Intelligence

Seattle, Washington, 98103, United States

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Adults with both normal and abnormal heart rates

Exclusion criteria

  • Under 18 years of age
  • Unable to speak and read English
  • Deemed not suitable to participate by Investigator due to cognitive impairment, acute illness, or serious physical or mental health condition
  • Essential tremor in left or right hand
  • Raynaud's disease
  • Severe calluses on left or right index finger
  • Unable to produce a heart rate measurement due to low signal quality during the training phase (i.e. low perfusion, unable to hold hand steady, etc)

Treatment and study plan

PreemptiveAI SDK

Device

Use the PreemptiveIAI SDK to measure heart rate.

Primary outcomes

  1. Heart Rate Error

    Time frame: At single site visit, measured across 8 repetitions within a 1-hour period

    Root mean square error of heart rate compared to ground truth device

Sponsors and collaborators

Lead sponsor

PreemptiveAI, Inc

Industry

Registry information

Official study title

Collection of Fingertip Video for Determination of Heart Rate

Important dates

Study start
2024
Primary completion
2024
Study completion
2025
First posted
Nov 20, 2024
Registry last updated
Nov 20, 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.