Wearable Blood Pressure Monitoring

August 26, 2022 updated by: Matti Kaisti, University of Turku

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

65

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Finland
      • Turku, Finland
        • Turku University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

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.

Description

Inclusion Criteria:

  • written concent from the participant

Exclusion Criteria:

  • pace maker, pregnancy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Other
  • Time Perspectives: Other

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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.
Device: sphygmomanometer, SpyghmoCor, CNAP500
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
up to 12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Turku

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2020

Primary Completion (Actual)

April 30, 2022

Study Completion (Actual)

April 30, 2022

Study Registration Dates

First Submitted

December 19, 2019

First Submitted That Met QC Criteria

January 3, 2020

First Posted (Actual)

January 6, 2020

Study Record Updates

Last Update Posted (Actual)

September 1, 2022

Last Update Submitted That Met QC Criteria

August 26, 2022

Last Verified

August 1, 2022

More Information

Terms related to this study

Other Study ID Numbers

  • 1574/31/2018

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Blood Pressure

Clinical Trials on sphygmomanometer, SpyghmoCor, CNAP500

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Türkiye

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe