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.

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.

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