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

PreemptiveAI, Inc

Status: Active, not recruiting

Conditions: Heart Rate in the General Public

Treatments: Device: PreemptiveAI SDK

Study type: Observational

Funder types: Industry

Identifiers

NCT06696339

HR-001

Details and patient eligibility

About

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

Enrollment: 100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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)