Pulse Rate and Breathing RateNCT06298981
Pulse Rate and Breathing Rate Accuracy
An observational study of Pulse Rate and Breathing Rate, run by Nuralogix Corporation at 1 site in United States.
Trial summary
The purpose of this study is to conduct a Breathing Rate and Pulse Rate accuracy validation comparing the NuraLogix AMC-SDK to the Reference devices, an FDA cleared End Tidal Carbon Dioxide monitor (GE Datex-Ohmeda) and a standard ECG (GE Datex-Ohmeda) derived heart rate reference. Read more about this study
- Who is it for?
- Ages 18 to 81 yearsHealthy volunteers can take part
- Conditions the study is for
- Pulse Rate and Breathing Rate
- What is being tested?
- noninvasive and investigational NuraLogix AMC-SDK
- Type of treatment
- Medical device
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Feb 2024to 30 Jun 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
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 to 81 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: The study population will be comprised of diversity in race, age, gender, BMI, skin tone, and health conditions. The health conditions will constitute inclusion of healthy controls (to allow testing over the full range of breaths per minute) and disease comorbidities (to represent comorbidities such as COPD, CHF, Asthma, Diabetes, Hypertension, and Obesity). An attempt will be made to enroll a variety of skin tones.
Who may be able to join
- Participants must have the ability to understand and provide written informed consent or have legally authorized representative consent to participate
- Participant must be 18 to 81 years of age (≥ 18 age to < 82)
- Participant must be willing and able to comply with study procedures and duration
- Participants or legally authorized representative must be able to read or write in English
Who cannot join
- Participants who refuse or are unable to provide to sign an informed written consent for study
- Participants evaluated by the Investigator and Clinical Staff and found to be medically - unsuitable or have self-reported health conditions that are currently unstable as identified in the Health Assessment Form and Health Screening
- Compromised circulation, injury, or physical malformation of fingers, toes, hands, ears or forehead/skull or other sensor Region of Interest (ROI) which would limit the ability to test ROI needed for the study. Tattoo in the optical path which would limit the ability to test ROI needed for the study. (Note: Certain malformations may still allow participants to participate if the condition is noted and would not affect the particular areas utilized.)
- Participants with severe contact allergies to standard adhesives, latex or other materials found in pulse oximetry sensors, ECG electrodes, or other medical sensors (self- reported)
- Other known health condition, should be considered upon disclosure in health assessment form
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Element Materials Technology
Louisville, Colorado, 80027
Monica Rabanal
About this study
Official title: Pulse Rate and Breathing Rate Accuracy Study - NuraLogix AMC-SDK
The purpose of this study is to conduct a Breathing Rate and Pulse Rate accuracy validation comparing the NuraLogix AMC-SDK to the Reference devices, an FDA cleared End Tidal Carbon Dioxide monitor (GE Datex-Ohmeda) and a standard ECG (GE Datex-Ohmeda) derived heart rate reference. This will be done by manually scoring the collected waveform for data analysis.
- Conditions
- Pulse Rate and Breathing Rate
- Being tested
- noninvasive and investigational NuraLogix AMC-SDK
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
noninvasive and investigational NuraLogix AMC-SDKDevice
The NuraLogix AMC-SDK is a noninvasive device that allows for real-time, remote measuring using facial recordings.
What is being measured
The primary outcome is the main question the study is designed to answer.
Breathing rate accuracy validation
The purpose of this study is to conduct a Breathing Rate accuracy validation comparing the NuraLogix AMC-SDK to the Reference, an FDA cleared End Tidal Carbon Dioxide monitor (GE Datex-Ohmeda) by manually scoring the collected waveform for data analysis
Measured: 1-2 hours
Pulse rate accuracy validation
This study will also assess the pulse rate measurements of the NuraLogix AMC-SDK for comparison to a standard ECG (GE Datex-Ohmeda) derived heart rate reference.
Measured: 1-2 hours
Secondary outcomes (1)
Pulse rate simulation
To assess a broader pulse rate range by manipulating the speed of recorded videos.
Measured: 1-2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2024
- Study start12 Feb 2024
- Primary completion30 Jun 2024 (estimated)
- Study completion30 Jun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulse Rate and Breathing RateStudies 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
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nuralogix Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06298981
- Sponsor's protocol ID
- 2301
- Status last verified
- Mar 2024
- First submitted
- 1 Mar 2024
- Last updated
- 22 Mar 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No plan to share IPD
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pulse Rate and Breathing Rate Accuracy Study - NuraLogix AMC-SDK
- ClinicalTrials.gov ID
- NCT06298981
- Acronym / sponsor ID
- 2301
- Conditions
- Pulse Rate and Breathing Rate
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Nuralogix CorporationIndustry (pharma, biotech, devices)
- Study start
- 12 Feb 2024 (actual)
- Primary completion
- 30 Jun 2024 (estimated)
- Study completion
- 30 Jun 2024 (estimated)
- First posted
- 7 Mar 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 purpose of this study is to conduct a Breathing Rate and Pulse Rate accuracy validation comparing the NuraLogix AMC-SDK to the Reference devices, an FDA cleared End Tidal Carbon Dioxide monitor (GE Datex-Ohmeda) and a standard ECG (GE Datex-Ohmeda) derived heart rate reference. This will be done by manually scoring the collected waveform for data analysis.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 to 81 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The study population will be comprised of diversity in race, age, gender, BMI, skin tone, and health conditions. The health conditions will constitute inclusion of healthy controls (to allow testing over the full range of breaths per minute) and disease comorbidities (to represent comorbidities such as COPD, CHF, Asthma, Diabetes, Hypertension, and Obesity). An attempt will be made to enroll a variety of skin tones.
Key inclusion criteria (4 listed)
- Participants must have the ability to understand and provide written informed consent or have legally authorized representative consent to participate
- Participant must be 18 to 81 years of age (≥ 18 age to < 82)
- Participant must be willing and able to comply with study procedures and duration
- Participants or legally authorized representative must be able to read or write in English
Key exclusion criteria (5 listed)
- Participants who refuse or are unable to provide to sign an informed written consent for study
- Participants evaluated by the Investigator and Clinical Staff and found to be medically - unsuitable or have self-reported health conditions that are currently unstable as identified in the Health Assessment Form and Health Screening
- Compromised circulation, injury, or physical malformation of fingers, toes, hands, ears or forehead/skull or other sensor Region of Interest (ROI) which would limit the ability to test ROI needed for the study. Tattoo in the optical path which would limit the ability to test ROI needed for the study. (Note: Certain malformations may still allow participants to participate if the condition is noted and would not affect the particular areas utilized.)
- Participants with severe contact allergies to standard adhesives, latex or other materials found in pulse oximetry sensors, ECG electrodes, or other medical sensors (self- reported)
- Other known health condition, should be considered upon disclosure in health assessment form
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 |
|---|---|---|
| noninvasive and investigational NuraLogix AMC-SDKThe NuraLogix AMC-SDK is a noninvasive device that allows for real-time, remote measuring using facial recordings. | Device | – |
Primary outcome
Breathing rate accuracy validation
Time frame: 1-2 hours
The purpose of this study is to conduct a Breathing Rate accuracy validation comparing the NuraLogix AMC-SDK to the Reference, an FDA cleared End Tidal Carbon Dioxide monitor (GE Datex-Ohmeda) by manually scoring the collected waveform for data analysis
Pulse rate accuracy validation
Time frame: 1-2 hours
This study will also assess the pulse rate measurements of the NuraLogix AMC-SDK for comparison to a standard ECG (GE Datex-Ohmeda) derived heart rate reference.
1 secondary outcome
Pulse rate simulation
Time frame: 1-2 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Mar 2024.
- Individual participant dataSharing planned: No. No plan to share IPD
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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.
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 Pulse Rate and Breathing Rate, run by Nuralogix Corporation 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 4 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 22 Mar 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Roberto Liddi ((647) 578-7925, robertoliddi@nuralogix.ai), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Breathing rate accuracy validation (time frame: 1-2 hours). The study lists 2 primary outcomes in all. 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 22 Mar 2024.