Assessment of Heart Rate Measurement Accuracy for the Pre... | NCT06696339

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

NCT06696339

Sponsor

PreemptiveAI, Inc

Status

Active, not recruiting

Last Update Posted

Nov 20, 2024Actual

Enrollment

100Estimated

Phase

Not provided

Conditions

Heart Rate in the General Public

Interventions

PreemptiveAI SDK

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2024

Overall Recruitment Status or Expanded Access Status

Active, not recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 3, 2024Actual

Primary Completion Date

Nov 15, 2024Estimated

Completion Date

Mar 1, 2025Estimated

First Submitted Date

Oct 23, 2024

First Submission Date that Met QC Criteria

Nov 18, 2024

First Posted Date

Nov 20, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 18, 2024

Last Update Posted Date

Nov 20, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Yes

Is Unapproved Device

Yes

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

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 provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

100Estimated

Name	Type	Description	Arm Group Labels	Other Names
PreemptiveAI SDK	Device	Use the PreemptiveIAI SDK to measure heart rate.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Heart Rate Error	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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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)

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Paul Allen Institute for Artificial Intelligence		Seattle	Washington	98103	United States

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided