Wearable Blood Pressure Monitoring

NCT04218032 | Completed

• 1 other identifier: 1574/31/2018
• Study Type: observational
• Target: 65
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this study is to develop and validate a new non-invasive medical instrumentation technology for blood pressure measurement.

Conditions

Blood Pressure

Outcome Measures

Primary Outcomes (1)

• 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.

  up to 12 weeks

Study Arms (1)

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

Interventions

sphygmomanometer, SpyghmoCor, CNAP500 DEVICE

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.

blood pressure

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• written concent from the participant

You may not qualify if:

• pace maker, pregnancy

Sponsors & Collaborators

• University of Turku: lead

Study Sites (1)

Turku University Hospital

Turku, Finland

Location

MeSH Terms

Interventions

Sphygmomanometers

Intervention Hierarchy (Ancestors)

Diagnostic Equipment; Equipment and Supplies

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Research Fellow

Study Record Dates

• First Submitted: December 19, 2019
• First Posted: January 6, 2020
• Study Start: March 1, 2020
• Primary Completion: April 30, 2022
• Study Completion: April 30, 2022
• Last Updated: September 1, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

FI (1)