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

Active, not recruiting
Conditions
Heart Rate in the General Public
Registration Number
NCT06696339
Lead Sponsor
PreemptiveAI, Inc
Brief Summary

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

Detailed Description

Not available

Recruitment & Eligibility

Status
ACTIVE_NOT_RECRUITING
Sex
All
Target Recruitment
100
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 & Design

Study Type
OBSERVATIONAL
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Heart Rate ErrorAt single site visit, measured across 8 repetitions within a 1-hour period

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

Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (1)

Paul Allen Institute for Artificial Intelligence

🇺🇸

Seattle, Washington, United States

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