HealthyNCT02444650
Measurement of Pulse Wave Velocity
An observational study of Healthy, run by Nonin Medical, Inc at 1 site in United States.
Trial summary
Optically-based data will be compared to tonometry to determine correlation of pulse wave velocity measurement. Read more about this study
- Who is it for?
- Ages 18 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Pulse wave velocity measurement Photoplethysmogram and tonometer
- Type of treatment
- Medical device
- How many people
- 32 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2015to Jul 2015
- 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 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Healthy normotensive and hypertensive subjects.
Who may be able to join
- Between the ages of18-25 and 65-90 will be studied.
- Normotensive and hypertensive subjects
- Willing to provide informed consent
Who cannot join
- has finger deformities or amputations that will prohibit proper sensor placement
- pregnant or actively trying to get pregnant
- Cardiogreen or other intravascular/tissue dyes less than 5 hours prior to the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Photoplethysmogram Measurement of Pulse Wave Velocity
Optically-based data will be compared to tonometry to determine correlation of pulse wave velocity measurement.
- Conditions
- Healthy
- Being tested
- Pulse wave velocity measurement Photoplethysmogram, tonometer
- Keywords
- Correlation, pulse wave velocity measurement, tonometry
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pulse wave velocity measurement PhotoplethysmogramDevice
Correlation of pulse wave velocity measurement.
tonometerDevice
What is being measured
The primary outcome is the main question the study is designed to answer.
Optically based pulse wave velocity measurement correlation to the tonometry measure.
Measured: 2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2015 (estimated)
- Study startApr 2015
- Primary completionJul 2015
- Study completionJul 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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
- Prospective
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nonin Medical, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Mayo Clinic
- Responsible party
- Sponsor
- Investigators
- Timothy Curry, MD, PhD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02444650
- Sponsor's protocol ID
- QATP2804
- Status last verified
- Jul 2015
- First submitted
- 29 Apr 2015
- Last updated
- 10 Jul 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Photoplethysmogram Measurement of Pulse Wave Velocity
- ClinicalTrials.gov ID
- NCT02444650
- Acronym / sponsor ID
- QATP2804
- Conditions
- Healthy
- Keywords
- Correlation, pulse wave velocity measurement, tonometry
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Nonin Medical, IncIndustry (pharma, biotech, devices)
- Collaborators
- Mayo Clinic
- Study start
- Apr 2015
- Primary completion
- Jul 2015 (actual)
- Study completion
- Jul 2015 (actual)
- First posted
- 14 May 2015 (estimated)
- 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.
Optically-based data will be compared to tonometry to determine correlation of pulse wave velocity measurement.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Healthy normotensive and hypertensive subjects.
Key inclusion criteria (3 listed)
- Between the ages of18-25 and 65-90 will be studied.
- Normotensive and hypertensive subjects
- Willing to provide informed consent
Key exclusion criteria (3 listed)
- has finger deformities or amputations that will prohibit proper sensor placement
- pregnant or actively trying to get pregnant
- Cardiogreen or other intravascular/tissue dyes less than 5 hours prior to the study.
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 |
|---|---|---|
| Pulse wave velocity measurement PhotoplethysmogramCorrelation of pulse wave velocity measurement. | Device | – |
| tonometer | Device | – |
Primary outcome
Optically based pulse wave velocity measurement correlation to the tonometry measure.
Time frame: 2 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2015.
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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.
Timothy Curry, MD, PhD principal investigator
Mayo Clinic
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 Healthy, run by Nonin Medical, 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 3 inclusion and 3 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: finished, as of the sponsor's last update on 10 Jul 2015. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Optically based pulse wave velocity measurement correlation to the tonometry measure. (time frame: 2 hours). 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 10 Jul 2015.