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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-10-03

Study Completion Date

2025-03-01

Brief Summary

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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

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Detailed Description

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Conditions

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Heart Rate in the General Public

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

CROSS_SECTIONAL

Interventions

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PreemptiveAI SDK

Use the PreemptiveIAI SDK to measure heart rate.

Intervention Type DEVICE

Eligibility Criteria

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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)

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes