Heart Rate in the General PublicNCT06696339
Assessment of Heart Rate Measurement Accuracy for the PreemptiveAI SDK in Adults
An observational study of Heart Rate in the General Public, run by PreemptiveAI, Inc at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Heart Rate in the General Public
- What is being tested?
- PreemptiveAI SDK
- Type of treatment
- Medical device
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Oct 2024to 1 Mar 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older 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
Who may be able to join
- Adults with both normal and abnormal heart rates
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
United States1 site
Paul Allen Institute for Artificial Intelligence
Seattle, Washington, 98103
About this study
Official title: Collection of Fingertip Video for Determination of Heart Rate
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
- Conditions
- Heart Rate in the General Public
- Being tested
- PreemptiveAI SDK
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PreemptiveAI SDKDevice
Use the PreemptiveIAI SDK to measure heart rate.
What is being measured
The primary outcome is the main question the study is designed to answer.
Heart Rate Error
Root mean square error of heart rate compared to ground truth device
Measured: At single site visit, measured across 8 repetitions within a 1-hour period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2024
- Study start3 Oct 2024
- Primary completion15 Nov 2024 (estimated)
- Study completion1 Mar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart Rate in the General PublicStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- PreemptiveAI, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06696339
- Sponsor's protocol ID
- HR-001
- Status last verified
- Nov 2024
- First submitted
- 23 Oct 2024
- Last updated
- 20 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Collection of Fingertip Video for Determination of Heart Rate
- ClinicalTrials.gov ID
- NCT06696339
- Acronym / sponsor ID
- HR-001
- Conditions
- Heart Rate in the General Public
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- PreemptiveAI, IncIndustry (pharma, biotech, devices)
- Study start
- 3 Oct 2024 (actual)
- Primary completion
- 15 Nov 2024 (estimated)
- Study completion
- 1 Mar 2025 (estimated)
- First posted
- 20 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older 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
Key inclusion criteria (1 listed)
- Adults with both normal and abnormal heart rates
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PreemptiveAI SDKUse the PreemptiveIAI SDK to measure heart rate. | Device | – |
Primary outcome
Heart Rate Error
Time frame: At single site visit, measured across 8 repetitions within a 1-hour period
Root mean square error of heart rate compared to ground truth device
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2024.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Heart Rate in the General Public, run by PreemptiveAI, Inc at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 20 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Heart Rate Error (time frame: At single site visit, measured across 8 repetitions within a 1-hour period). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Nov 2024.