Comparing PPG-based Blood Pressure Measurement to the Gold Standard Manometer

NCT03810586 | Completed

• 1 other identifier: Biobeat002
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

Brief Summary

Continuous blood pressure (BP) measurement is in use today with an ambulatory, sphygmomanometer-based, device. This device, also called BP Holter, gives essential data for the clinician, allowing better hypertension (HTN) diagnosis and treatment. Alongside, the device has some substantial limitations preventing its use as a longer term BP monitoring allowing better HTN control. A new method of continuous BP monitoring, based on photo plethysmography (PPG), has been invented to ease patients' use and increase their responsiveness. This study aims to check whether the new, PPG-based method, of BP measurement can be as good as the current, gold standard, sphygmomanometer-based device.

Conditions

Hypertension; Blood Pressure Disorders

Keywords

Hypertension; Continuous Monitoring; Non-invasive Blood Pressure; Non-invasive Monitoring

Outcome Measures

Primary Outcomes (1)

• Accurate and comparable blood pressure measurement by BB-613

  Blood pressure measurements using the PPG-based BB-613 device will be taken and compared to blood pressure measurements taken at the same time using the holter device HUGECARE NIBP Monitor, with the aim of showing they are comparable

  24 hours per participant

Study Arms (1)

Comparing blood pressure measurement

EXPERIMENTAL

In each volunteer, non-invasive measurements of blood pressure will be taken at the same time using a holter manometry device (HUGECARE NIBP Monitor) and the Biobeat BB-613 device, and compared, to show the accuracy and the comparability of the BB-613. As mentioned in the protocol, there would be no medical interventions within the scope of this study. In case hypertension will be observed in a volunteer, the volunteer will be advised by the investigators to see his physician for further evaluation.

Device: Non-invasive measurement of blood pressure

Interventions

Non-invasive measurement of blood pressure DEVICE

Comparing non-invasive measurement of blood pressure using the PPG-based BB-613 device to a blood pressure manomtry holter device (HUGECARE NIBP Monitor)

Comparing blood pressure measurement

Eligibility Criteria

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

You may qualify if:

• Either healthy or chronically ill who are treated accordingly and with no need of any medical intervention during the study.

You may not qualify if:

• A volunteer's refusal to enter the study.
• Patients who are currently in hospitalization or in medical assessment.
• Pregnant women and children under 18.
• Volunteers with powerless jurisdiction.
• Workers of the Hadassah Medical Center

Sponsors & Collaborators

• Biobeat Technologies Ltd.: lead

Study Sites (1)

The Hadassah Ein Kerem Medical Center

Jerusalem, Israel

Location

Related Publications (1)

• Nachman D, Gilan A, Goldstein N, Constantini K, Littman R, Eisenkraft A, Grossman E, Gepner Y. Twenty-Four-Hour Ambulatory Blood Pressure Measurement Using a Novel Noninvasive, Cuffless, Wireless Device. Am J Hypertens. 2021 Nov 20;34(11):1171-1180. doi: 10.1093/ajh/hpab095.

  PMID: 34143867 DERIVED

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Study Officials

• Dean Nachman, MD

  The Hadassah Ein Kerem Medical Center, Jerusalem

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Recruitment will be via printed advertisements distributed throughout the medical center. Volunteers will arrive on the morning of the test and fill a questionnaire about their demographics and every day activities. After completing the questionnaire, the participants will be connected to both devices, one on each arm and undergo a briefing about both devices. A first calibration measurement will take place followed by BP measurement every 20 minutes, and up to a 24 hour period. After 24 hours of measurements, the participants will return to Hadassah Medical Center and fill in another questionnaire, which will include feedback on the use of both devices.

Study Record Dates

• First Submitted: January 17, 2019
• First Posted: January 18, 2019
• Study Start: April 15, 2019
• Primary Completion: April 25, 2020
• Study Completion: June 25, 2020
• Last Updated: July 9, 2020

Record last verified: 2019-07

Locations

IL (1)