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

November 18, 2024 updated by: PreemptiveAI, Inc

Collection of Fingertip Video for Determination of Heart Rate

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

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Washington
      • Seattle, Washington, United States, 98103
        • Paul Allen Institute for Artificial Intelligence

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.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

At least 60 participants, up to 125 participants. Participants will be recruited to meet the following demographics goals:

  • Sex assigned at birth - a minimum of 25 male and 25 female participants
  • Age - a minimum of 10 participants in each age bin: 18-30, 30-65, 65+
  • BMI - a minimum of 5 participants in each bin: 0-25, 25-30.0, 30.0+
  • Skin tone (Fitzpatrick scale) - a minimum of 10 participants in each bin: Type 1/2, Type 3/4, Type 5/6
  • Heart Rate - a minimum of 5 participants with average heart rate < 60 bpm and >100 bpm

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
At single site visit, measured across 8 repetitions within a 1-hour period

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

PreemptiveAI, Inc

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 Major Dates

Study Start (Actual)

October 3, 2024

Primary Completion (Estimated)

November 15, 2024

Study Completion (Estimated)

March 1, 2025

Study Registration Dates

First Submitted

October 23, 2024

First Submitted That Met QC Criteria

November 18, 2024

First Posted (Estimated)

November 20, 2024

Study Record Updates

Last Update Posted (Estimated)

November 20, 2024

Last Update Submitted That Met QC Criteria

November 18, 2024

Last Verified

November 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

  • HR-001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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