Heart Rate and Respiratory Rate Measurements by a Novel, Radar-based Device

Single Center, Single Blinded, Prospective Validation Study for the Accuracy and Safety Evaluation of Neteera 130H, a Novel, Radar-based Contact-free Device for Heart and Respiratory Rate Measurements

A single center, single blinded, prospective validation (including extension0 study for the accuracy and safety evaluation of Neteera 130H, a novel, radar-based contact-free device for heart and respiratory rate measurements.

Study Overview

• Status: Completed
• Conditions: Healthy Subjects; Chronic Conditions, Multiple
• Intervention / Treatment: Device: Neteera 130H

Detailed Description

This is a single-blinded, prospective validation study for the accuracy and safety evaluation of Neteera 130H, a novel, radar-based contact-free device for heart and respiratory rate measurements compared to reference devices.

Each subject will have a single study visit in which the subjects will be screened and upon eligibility confirmation, will undergo HR and RR measurements using the investigational device as well as the reference devices. In a previous clinical trial (NET-MED-002) 100 subjects were measured in the sitting position. In the extension study part (NET-MED-002-EXT), 70 eligible subjects, 18 years old and above, suffering from chronic medical conditions, will be enrolled. In this extension part, 70 of the subjects will be measured while randomly assigned into one of two groups - 35 subjects in group A (sitting position) and 35 subjects in sleep posture//group B (lying in bed/sleeping posture position) in a ratio of 1:1. Data from the previous study and the Extension study will be pooled for final analysis.

• Study Type: Observational
• Enrollment (Actual): 170

Contacts and Locations

Study Locations

• Israel
  • Jerusalem, Israel
    • Shaare Zedek Medical Center
• United States
  • Utah
    • Millcreek, Utah, United States, 84107
      • JBR Clinical Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Males and females, 18 years old and above willing and able to provide an informed consent and eligible according to the eligibility criteria.

Description

Inclusion Criteria (NET-MED-002):

• Age ≥ 18 years

Inclusion Criteria (NET-MED-002-EXT):

• Age ≥ 18 years
• One (or more) chronic medical condition/s

Exclusion Criteria (NET-MED-002):

• Children under the age of 18 years
• Pregnant or lactating women - as confirmed by a home pregnancy test kit
• Current irregular heart rate (e.g. Atrial fibrillation) - as assessed by a targeted physical examination during screening
• Current shortness of breath, respiratory distress, or other clinical signs of hemodynamic instability - as assessed by a targeted physical examination during screening
• Prior major surgical and/or orthopedical and/or trauma in the thorax
• Participation in an investigational trial within 30 days of the screening visit
• Subjects that will not be able to complete the trial, according to the PI or SI evaluation

Exclusion Criteria (NET-MED-002-EXT)

• Children under the age of 18 years
• Prior major trauma in the thorax
• Participation in an investigational trial within 30 days of the screening visit
• Subjects that will not be able to complete the trial, according to the PI or SI evaluation

Study Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of accurate spot HR while the Neteera 130H located behind the subject.	Proportion of accurate spot HR (BPM) measurements of the investigated device, while located behind the subject, in sitting position compared to the reference device measurements	During 60 seconds, from t = 0:00 min to t = 1:00
Proportion of accurate spot RR while the Neteera 130H located behind the subject.	Proportion of accurate spot RR (BrPM) measurements of the investigated device in sitting position, while located behind the subject, compared to reference device (capnograph) measurements	During 60 seconds, from t = 0:00 min to t = 1:00

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Repeating the primary endpoints in sitting position while the investigated device is located in front of the subject.	1) Repeating the primary endpoints in sitting position while the investigated device is located in front of the subject.	During 60 seconds, from t = 0:00 min to t = 1:00
Repeating the previous endpoints (where applicable) in sleep posture/lying in bed position, while the investigated device is located above of the subject.	Repeating the previous endpoints (where applicable) in sleep posture/lying in bed position, while the investigated device is located above of the subject.	During 60 seconds
Repeating previous endpoint positions (where applicable) comparing investigated device continuous HR and RR measurements to reference device continuous measurements	Repeating previous endpoint positions (where applicable) comparing investigated device continuous HR and RR measurements to reference device continuous measurements	During 5 minutes of the continuous measurement

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety Endpoint	Percent of subjects with device related adverse events.	from screening until the end of study measurements

Collaborators and Investigators

• Sponsor: Neteera Technologies Ltd.
• Investigators: Principal Investigator: Todd Bertoch, MD, JBR Clinical Research

Study record dates

Study Major Dates

• Study Start (Actual): February 21, 2021
• Primary Completion (Actual): March 25, 2022
• Study Completion (Actual): July 2, 2022

Study Registration Dates

• First Submitted: March 8, 2021
• First Submitted That Met QC Criteria: March 11, 2021
• First Posted (Actual): March 12, 2021

Study Record Updates

• Last Update Posted (Actual): October 5, 2022
• Last Update Submitted That Met QC Criteria: October 4, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Chronic Disease; Multiple Chronic Conditions
• Other Study ID Numbers: NET-MED-002-EXT

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No