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

NCT ID: NCT04796181

Last Updated: 2022-10-05

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 170 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-02-21
• Study Completion Date: 2022-07-02

Brief Summary

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.

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.

Conditions

Healthy Subjects; Chronic Conditions, Multiple

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: PROSPECTIVE

Interventions

Neteera 130H

The Neteera 130H will used to perform measurements in proximity to study participants.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Age ≥ 18 years

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

Exclusion Criteria

• 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

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Neteera Technologies Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Todd Bertoch, MD

Role: PRINCIPAL_INVESTIGATOR

JBR Clinical Research

Locations

JBR Clinical Research

Millcreek, Utah, United States

Shaare Zedek Medical Center

Jerusalem, , Israel

Countries

United States; Israel

Other Identifiers

NET-MED-002-EXT

Identifier Type: -

Identifier Source: org_study_id