Clinical trial NCT04796181: Heart Rate and Respiratory Rate Measurements by a Novel, Radar-based Device
Official title: 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Healthy Subjects
Chronic Conditions, Multiple
Lead sponsor: Neteera Technologies Ltd.
Sponsor class: INDUSTRY
First posted: 2021-03-12
Enrollment: 170
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Proportion of accurate spot HR while the Neteera 130H located behind the subject.
timeFrame: During 60 seconds, from t = 0:00 min to t = 1:00
measure: Proportion of accurate spot RR while the Neteera 130H located behind the subject.
timeFrame: During 60 seconds, from t = 0:00 min to t = 1:00
Secondary outcomes:
measure: Repeating the primary endpoints in sitting position while the investigated device is located in front of the subject.
timeFrame: During 60 seconds, from t = 0:00 min to t = 1:00
measure: Repeating the previous endpoints (where applicable) in sleep posture/lying in bed position, while the investigated device is located above of the subject.
timeFrame: During 60 seconds
measure: Repeating previous endpoint positions (where applicable) comparing investigated device continuous HR and RR measurements to reference device continuous measurements
timeFrame: During 5 minutes of the continuous measurement
Other outcomes:
measure: Safety Endpoint
timeFrame: from screening until the end of study measurements
Locations:
city: Millcreek
country: United States
facility: JBR Clinical Research
state: Utah
city: Jerusalem
country: Israel
facility: Shaare Zedek Medical Center
Study officials:
affiliation: JBR Clinical Research
name: Todd Bertoch, MD
role: PRINCIPAL_INVESTIGATOR
References: