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

NCT04796181 | Completed

• 1 other identifier: NET-MED-002-EXT
• Study Type: observational
• Target: 170
• Locations: 2 countries
• Sites: 2

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.

Conditions

Healthy Subjects; Chronic Conditions, Multiple

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• 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.

  During 60 seconds

• 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 Outcomes (1)

• Safety Endpoint

  from screening until the end of study measurements

Interventions

Neteera 130H DEVICE

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

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Neteera Technologies Ltd.: lead

Study Sites (2)

JBR Clinical Research

Millcreek, Utah, 84107, United States

Location

Shaare Zedek Medical Center

Jerusalem, Israel

Location

MeSH Terms

Conditions

Multiple Chronic Conditions

Condition Hierarchy (Ancestors)

Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Todd Bertoch, MD

  JBR Clinical Research

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Day
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 8, 2021
• First Posted: March 12, 2021
• Study Start: February 21, 2021
• Primary Completion: March 25, 2022
• Study Completion: July 2, 2022
• Last Updated: October 5, 2022

Record last verified: 2022-02

Locations

IL (1); US (1)