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

Collection of Fingertip Video for Determination of Heart Rate

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06696339
Enrollment
100
Registered
2024-11-20
Start date
2024-10-03
Completion date
2025-03-01
Last updated
2024-11-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Heart Rate in the General Public

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

Interventions

DEVICEPreemptiveAI SDK

Use the PreemptiveIAI SDK to measure heart rate.

Sponsors

PreemptiveAI, Inc
Lead SponsorINDUSTRY

Study design

Observational model
CASE_ONLY
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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)

Design outcomes

Primary

MeasureTime frameDescription
Heart Rate ErrorAt single site visit, measured across 8 repetitions within a 1-hour periodRoot mean square error of heart rate compared to ground truth device

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026