Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT02740504 |
| Other study ID # |
D22105-106 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
January 2015 |
| Est. completion date |
March 2015 |
Study information
| Verified date |
March 2021 |
| Source |
ResMed |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial Summary
A trial conducted within the company with a new non-contact respiration rate (RR) sensor. The
device was compared for accuracy in RR measurement with a cleared device, the SOMNOScreen
Easy, which uses chest effort bands.
The RR was measured over a short duration on subjects sitting upright in a chair, with the
non-contact sensor at various distances from the subject. A total of 20 subjects were tested,
from both genders, selected to represent a wide range of age and body mass index
Description:
The Reassure uses Radio Frequency (RF) waves to detect the small movements of the human body
due to respiration. The reference device, the SOMNOScreen, uses chest effort bands. The
Reassure is non-contact and so more comfortable and convenient for quick RR measurement, in a
similar way that an Infra-Red thermometer is compared to a traditional under-the-tongue
mercury thermometer.
The aim is to explore the variations in the human body that could have an effect on the radio
reflection from the human torso, and thus affect the potential detection and accuracy of
breathing rate. Factors that could affect non-contact RF performance are:
- High Body Mass Index (BMI) could potentially reduce the chest wall movement during
breathing, or alter the nature of the breathing.
- Elderly, thin skin (ie pensioner with low BMI) may have less RF reflection.
- Female breast tissue may have an effect on detection or accuracy.
This was tested at a number of distances from the non-contact sensor and also with the
subject having a thick comforter (duvet) laid across them.
The test conditions were
- Distances of 0.5 m, 1.0m and 1.5m between the subject and the RF sensor.
- Additional test condition of comforter (duvet) on the subject when the distance from
subject to sensor is 1.0 m.
- Each test condition carried out twice.
The use of the comforter in one test condition is to confirm that the RR measurement by the
Reassure is unaffected by the thickness of clothing or blankets being worn.
