Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT01319396 |
| Other study ID # |
BM07_8DTS |
| Secondary ID |
|
| Status |
Completed |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
October 2010 |
| Est. completion date |
March 2011 |
Study information
| Verified date |
March 2021 |
| Source |
ResMed |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial Summary
The purpose of this study is to compare the accuracy of the BiancaMed BM07 breathing
frequency indicator device with the respiration rate measured by a SomnoScreen RC Easy device
on 20+ human volunteers. This is being carried out in support of a 510(k) submission.
Description:
The purpose of this study is to compare the accuracy of the BiancaMed BM07 breathing
frequency indicator device with the respiration rate measured by a SomnoScreen RC Easy device
on 20+ human volunteers. This is being carried out in support of a 510(k) submission.
- The BM07 is a non-contact device, using radio frequency (RF) range measurement to detect
the chest wall motion, and thus the respiration rate. The BM07 is a CE Class IIa cleared
device.
- The SomnoScreen RC Easy is both a CE and FDA (K060708) cleared device, used as an
overnight, portable sleep recorder. One of its inputs is a pair of chest respiration
effort bands that can be used to record the breathing rate of the subject.
- The human volunteers are selected to be a range of age, body mass index (BMI) and gender
so as to cover a broad cross section of the population. BMI, gender and age are features
that might affect the performance of the RF reflected signal:
- High BMI or low BMI could affect the skin RF reflectivity.
- High BMI may mask chest wall movement during breathing.
- The thinner skin often associated with increasing age may affect RF reflectivity.
- Female breast tissue may affect RF reflectivity or mask chest wall movement.
The target performance is an agreement between the BM07 and the Somnoscreen of +/- 5 breaths
per minute. This target has been selected based upon a literature review, in particular:
- Lim et al: Respiratory Rate Measurement in Adults - How Reliable is it?
- Droitcour PhD Thesis: Non-Contact Measurement of Heart and Respiration Rates with a
Single-Chip Microwave Doppler Radar.
There is no risk to the subjects as the RF energy emitted by the BM07 is much less than that
of either a mobile phone bluetooth or a domestic WLAN router.
The testing is to be carried out on volunteer human subjects, who sign a consent form. The
locations of testing are Dublin, Ireland and Belfast, UK.
The testing comprises the subjects sitting still for periods of 2 minutes whilst recordings
are taken from both the BM07 and Somnoscreen. The test configurations are ranges from the
BM07 to subject of 0.5, 1.0 & 1.5m and 1.0m with a thick folded duvet (overblanket/comforter)
covering the subject to represent them wearing thick outdoor winter clothing. Each test
configuration is carried out twice, making a total of 8 test recordings per subject.
The first 2 volunteers will be used to confirm that the maximum effective range of the BM07
is at least 1.5 m and that the target aspect of the subject (ie the sensor being in front, to
one side and from behind) does not affect the ability of the BM07 to detect breathing
movement.
This is an Observational study as the subjects are normal healthy volunteers and no
intervention can be made as a result of the study measurements
