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

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ClinicalTrials.gov Identifier: NCT03810586
Recruitment Status : Not yet recruiting
First Posted : January 18, 2019
Last Update Posted : January 21, 2019
Sponsor:
Information provided by (Responsible Party):
Biobeat Technologies Ltd.

Tracking Information
First Submitted Date  ICMJE January 17, 2019
First Posted Date  ICMJE January 18, 2019
Last Update Posted Date January 21, 2019
Estimated Study Start Date  ICMJE February 2019
Estimated Primary Completion Date August 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 17, 2019)
Accurate and comparable blood pressure measurement by BB-613 [ Time Frame: 24 hours per participant ]
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
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03810586 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Comparing PPG-based Blood Pressure Measurement to the Gold Standard Manometer
Official Title  ICMJE Comparison of Continuous Blood Pressure Measurement Using a Non-invasive Photo Plethysmography-based Monitor With the Gold Standard Sphygmomanometer-based Holter Monitor
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.
Detailed Description

HTN is a major risk factor for cerebrovascular morbidity and mortality, yet its identification can be delayed due to lack of overt symptoms, relying on BP measurements for diagnosis. Several BP monitoring techniques are used in clinics and hospitals, and there is also an outpatient method that is used for 24-hour BP monitoring, based on a sphygmomanometer. The general notion is that by using tight BP monitoring in the clinic and during the day, the health system will be able to diagnose hypertension among individuals at an early stage, including high risk patients in the community.

Ambulatory BP monitoring for a period of 24 hours is considered to be better than measurements taken in a clinic setting. First, 24 hours monitoring performed at home can help confirm that hypertension actually does exist, thus ruling out the potential of "white coat syndrome". Second, measurements of BP during sleep also have a predictive value for hypertension in high risk patients. Furthermore, ambulatory BP measurements are a stronger predictor of all-cause and cardiovascular mortality than BP measurements in the clinic. Finally, continuous BP monitoring is beneficial for controlling hypertension in diagnosed and treated patients.

The gold standard ambulatory non-invasive BP monitor that is in broad use today is a sphygmomanometer-based device that includes a cuff, which contracts around the patient's arm and measures BP every 15 to 20 minutes. The cuff is usually uncomfortable for the patients and could prevent them from doing their everyday activities. It can also disrupt the quality of their sleep at night. For these reasons patients are sometimes reluctant to use it. A more comfortable, user- friendly device, which allows a non-invasive, continuous BP measurement will provide a simple, more efficient way for BP monitoring, and will potentially enable to improve the outcome of medical treatment.

A new way for continuous non-invasive BP monitoring is based on the reflective photo plethysmography (PPG) method. A company called "Biobeat" invented a device that measures PPG wave in high temporal resolution that maintains more properties and markings of the original pulse wave than usual PPG-based devices, thereby enabling to provide data on several physiological parameters other than Heart Rate (HR) and blood oxygen saturation, such as: Systolic Blood Pressure (SBP) and its variation, Diastolic Blood Pressure (DBP) and its variation, Pulse Pressure and more. This device can also send and surveillance. The Biobeat device (BB-613) includes either a wearable watch or a patch with a sticker that the patient puts on his/her body. This device may increase the patient's willingness to use it and can also make the measurement more reliable (explanation on the PPG-based sensor and the device itself are provided in the appendixes).

The measurements are transferred via Wi-Fi to the patient's doctor and allows close monitoring.

The purpose of the study The study's main purpose is to compare continuous 24-hour BP measurement using the non-invasive PPG-based BB-613 device with one of the gold standard sphygmomanometer-based devices that is currently-used throughout the Israeli health system (HUGECARE NIBP Monitor). As accepted according to the AAMI (Association for the Advancement of Medical Instrumentation) and the European Hypertension Society, the parameters that are investigated in this study will be systolic BP, diastolic BP and the average between them (MAP).

The use of the PPG sensor for BP measurement will be considered as successful if there will be correlation of at least 5/10/15 mmHg between the measurements of both the PPG sensor and the sphygmomanometer-based Holter. The difference between measurements of the PPG and manometer devices will be less than 5 mmHg in at least 75% of the measurements, less than 10 mmHg in at least 90% of the measurements and less than 15 mmHg in at least 96% of the measurements. The results will fulfil at least two of these criteria.

In addition to the BP measurement comparison, in this study the investigators will also compare the degree of comfort and accessibility for participants between the Bio Beat device and the gold standard Holter device that is currently in use.

Study hypothesis The study's hypothesis is that the PPG-based sensor will give reliable results of continuous BP monitoring in a comfortable and user-friendly way. In addition, the accuracy of the sensor will not be inferior to the Holter that is now in use.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Intervention Model: Single Group Assignment
Intervention Model Description:
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.
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE
  • Hypertension
  • Blood Pressure Disorders
Intervention  ICMJE Device: Non-invasive measurement of blood pressure
Comparing non-invasive measurement of blood pressure using the PPG-based BB-613 device to a blood pressure manomtry holter device (HUGECARE NIBP Monitor)
Study Arms  ICMJE Experimental: Comparing blood pressure measurement
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.
Intervention: Device: Non-invasive measurement of blood pressure
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: January 17, 2019)
30
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE January 2020
Estimated Primary Completion Date August 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

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

Exclusion Criteria:

  • 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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Arik Eisenkraft, MD, MHA +972-52-9210896 dr.arik@bio-beat.com
Contact: Arik Ben-Ishay +972-53-5287768 arik@bio-beat.com
Listed Location Countries  ICMJE Israel
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03810586
Other Study ID Numbers  ICMJE Biobeat002
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Biobeat Technologies Ltd.
Study Sponsor  ICMJE Biobeat Technologies Ltd.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Dean Nachman, MD The Hadassah Ein Kerem Medical Center, Jerusalem
PRS Account Biobeat Technologies Ltd.
Verification Date January 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP