Blood PressureNCT04218032
Wearable Blood Pressure Monitoring
An observational study of Blood Pressure, run by University of Turku at 1 site in Finland.
Trial summary
The goal of this study is to develop and validate a new non-invasive medical instrumentation technology for blood pressure measurement. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Blood Pressure
- What is being tested?
- sphygmomanometer, SpyghmoCor, CNAP500
- Type of treatment
- Medical device
- How many people
- 65 participants
- Where
- 1 siteFinland
- Study dates
- 1 Mar 2020to 30 Apr 2022
- 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 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: 33 volunteers (weight: mean 77 kg [range:48 to 117 kg]; height: mean 176 cm [range: 161 to 194 cm]; age: mean 32 [range: 23 to 75 years], 8 females) The subjects had a blood pressure range (DBP: 56 to 84 mmHg, SBP: 93 to 146 mmHg) and four of them were on blood pressure medication. Three measurements were performed on both the reference and the experimental device from which an average was calculated 32 volunteers (age: mean 47 years [range: 24 to 83 years], 5 women). The validation study was carried out at Turku University Hospital. For reference manual auscultation was performed by two trained observers, and the maximum acceptable difference between the readings from the observers was 4 mmHg for both SBP and DBP. After an initial test measurement, three measurements were taken in a cyclical manner one device after another, both with the finger device and by auscultation.
Who may be able to join
- written concent from the participant
Who cannot join
- pace maker, pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Verenpaineen Seuranta Paineanturi-matriisilla
The goal of this study is to develop and validate a new non-invasive medical instrumentation technology for blood pressure measurement.
Read the detailed description
The goal of this study is to develop and validate a new non-invasive medical instrumentation technology for assessing haemodynamic status measured from the fingertip using oscillometry. . As the finger pressing pressure is ramped up and then slowly down, an oscillometric response is recorded. From this signal the mean arterial pressure is found from which systolic and diastolic pressure is computed along with the full pressure waveform.
- Conditions
- Blood Pressure
- Being tested
- sphygmomanometer, SpyghmoCor, CNAP500
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sphygmomanometer, SpyghmoCor, CNAP500Device
blood pressure is measured with developed new non-invasive technology, oscillometry from the fingertip, and compared to non-invasive standard blood pressure measurement using a standard sphygmomanometer/SpyghmoCor device/CNAP500 device.
| Study group | Role | What they receive |
|---|---|---|
| blood pressure | blood pressure is measured from the participants, by using two methods. A new developed device and a reference device. The new device measures, using oscillometry, the blood pressure from the finger tip. The reference device is a standard sphygmomanometer. Receives: Device: sphygmomanometer, SpyghmoCor, CNAP500 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Accuracy of new blood pressure measurement technology.
the accuracy of new developed blood pressure measurement technology is validated against existing gold standard method by comparing systolic and diastolic blood pressure values between the two.
Measured: up to 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2020
- Study start1 Mar 2020
- Primary completion30 Apr 2022
- Study completion30 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Blood PressureStudies 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
- Other
- Time perspective
- Other
- Enrolment
- 65 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Turku
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Matti Kaisti, University of Turku
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04218032
- Sponsor's protocol ID
- 1574/31/2018
- Status last verified
- Aug 2022
- First submitted
- 19 Dec 2019
- Last updated
- 1 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Verenpaineen Seuranta Paineanturi-matriisilla
- ClinicalTrials.gov ID
- NCT04218032
- Acronym / sponsor ID
- 1574/31/2018
- Conditions
- Blood Pressure
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 65 participants (actual)
- Lead sponsor
- University of TurkuUniversity, hospital or other
- Study start
- 1 Mar 2020 (actual)
- Primary completion
- 30 Apr 2022 (actual)
- Study completion
- 30 Apr 2022 (actual)
- First posted
- 6 Jan 2020 (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 study is to develop and validate a new non-invasive medical instrumentation technology for blood pressure measurement.
Detailed description
The goal of this study is to develop and validate a new non-invasive medical instrumentation technology for assessing haemodynamic status measured from the fingertip using oscillometry. . As the finger pressing pressure is ramped up and then slowly down, an oscillometric response is recorded. From this signal the mean arterial pressure is found from which systolic and diastolic pressure is computed along with the full pressure waveform.
Study design
- Observational model
- Other
- Time perspective
- Other
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| blood pressure | – | Device: sphygmomanometer, SpyghmoCor, CNAP500blood pressure is measured from the participants, by using two methods. A new developed device and a reference device. The new device measures, using oscillometry, the blood pressure from the finger tip. The reference device is a standard sphygmomanometer. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- 33 volunteers (weight: mean 77 kg [range:48 to 117 kg]; height: mean 176 cm [range: 161 to 194 cm]; age: mean 32 [range: 23 to 75 years], 8 females) The subjects had a blood pressure range (DBP: 56 to 84 mmHg, SBP: 93 to 146 mmHg) and four of them were on blood pressure medication. Three measurements were performed on both the reference and the experimental device from which an average was calculated 32 volunteers (age: mean 47 years [range: 24 to 83 years], 5 women). The validation study was carried out at Turku University Hospital. For reference manual auscultation was performed by two trained observers, and the maximum acceptable difference between the readings from the observers was 4 mmHg for both SBP and DBP. After an initial test measurement, three measurements were taken in a cyclical manner one device after another, both with the finger device and by auscultation.
Key inclusion criteria (1 listed)
- written concent from the participant
Key exclusion criteria (1 listed)
- pace maker, pregnancy
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 |
|---|---|---|
| sphygmomanometer, SpyghmoCor, CNAP500blood pressure is measured with developed new non-invasive technology, oscillometry from the fingertip, and compared to non-invasive standard blood pressure measurement using a standard sphygmomanometer/SpyghmoCor device/CNAP500 device. | Device | blood pressure |
Primary outcome
Accuracy of new blood pressure measurement technology.
Time frame: up to 12 weeks
the accuracy of new developed blood pressure measurement technology is validated against existing gold standard method by comparing systolic and diastolic blood pressure values between the two.
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 1 Sep 2022.
- Individual participant dataSharing planned: No
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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.
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 Blood Pressure, run by University of Turku at 1 site in Finland.
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 1 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 1 Sep 2022. 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 Finland. 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?
Accuracy of new blood pressure measurement technology. (time frame: up to 12 weeks). 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 1 Sep 2022.