Chronic Conditions, Multiple, Healthy Subjects
Conditions
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.
Interventions
DEVICENeteera 130H
The Neteera 130H will used to perform measurements in proximity to study participants.
Sponsors
Neteera Technologies Ltd.
Study design
Observational model
OTHER
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 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. |
| 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 |
Other
| Measure | Time frame | Description |
|---|---|---|
| Safety Endpoint | from screening until the end of study measurements | Percent of subjects with device related adverse events. |
Countries
Israel, United States
Outcome results
None listed