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

Completed

• Conditions: Healthy Subjects; Chronic Conditions, Multiple

• Registration Number: NCT04796181
• Lead Sponsor: Neteera Technologies Ltd.

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.

Study Timeline

• Study Start: 2021-02-21
• Study First Submitted: 2021-03-08
• Study First Submitted QC: 2021-03-11
• Study First Posted: 2021-03-12
• Status Verified: 2022-02
• Primary Completion: 2022-03-25
• Study Completion: 2022-07-02
• Last Update Submitted: 2022-10-04
• Last Update Posted: 2022-10-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 170

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Proportion of accurate spot HR while the Neteera 130H located behind the subject.	During 60 seconds, from t = 0:00 min to t = 1:00	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
Proportion of accurate spot RR while the Neteera 130H located behind the subject.	During 60 seconds, from t = 0:00 min to t = 1:00	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

Secondary Outcome Measures

Name	Time	Method
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	1) Repeating the primary endpoints in sitting position while the investigated device is located in front of the subject.
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	Repeating previous endpoint positions (where applicable) comparing investigated device continuous HR and RR measurements to reference device continuous measurements
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 the previous endpoints (where applicable) in sleep posture/lying in bed position, while the investigated device is located above of the subject.

Trial Locations

Locations (2)

JBR Clinical Research; 🇺🇸 Millcreek, Utah, United States

Shaare Zedek Medical Center; 🇮🇱 Jerusalem, Israel