Unspecified Threat to Breathing
Conditions
Keywords
breathing rate
Brief 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.
Detailed 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
Interventions
None listed
Sponsors
ResMed
Study design
Observational model
CASE_ONLY
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
ALL
Age
10 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* volunteer * consent
Exclusion criteria
none
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Respiration Rate Accuracy - Mean Difference in Breaths Per Minute Between the BM07 5GHz Sensor and SomnoScreen Devices | Recording duration of 2 minutes; measurement made after 45 seconds settling time, for at least 60 seconds | The respiration rate measured contemporaneously by the BM07 5GHz sensor and the reference device, SomnoScreen, are compared on a second-by-second basis, over the recording duration. The difference between the two respiration rate measurements (the delta) for all 24 subjects' recordings, in all positions, are plotted on a normal distribution chart, giving 10,542 data points. The distribution chart reveals the mean difference between the two devices' measurements and the Standard Deviation (SD). The measure of success is if the 95% (ie 2SD) of the difference in the respiration rate indicated by the two devices (the delta) is less than 5 breaths per minute. This measure is derived from the peer review paper by Lim et al, cited in the References section |
Countries
Ireland
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 5.8 GHz Sensor Spot Respiration Rate All participants had the difference in indicated breathing rate measured. The 2 devices were the BM07 5GHz non-contact sensor (device under test) and the Somnoscreen (reference device using chest effort bands) | 24 |
| Total | 24 |
Baseline characteristics
| Characteristic | 5.8 GHz Sensor Spot Respiration Rate |
|---|---|
| Age, Categorical <=18 years | 2 Participants |
| Age, Categorical >=65 years | 2 Participants |
| Age, Categorical Between 18 and 65 years | 20 Participants |
| Age, Continuous | 40.6 years STANDARD_DEVIATION 14.1 |
| Region of Enrollment Ireland | 15 participants |
| Region of Enrollment United Kingdom | 9 participants |
| Sex: Female, Male Female | 8 Participants |
| Sex: Female, Male Male | 16 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 24 |
| serious Total, serious adverse events | 0 / 24 |
Outcome results
Primary
Respiration Rate Accuracy - Mean Difference in Breaths Per Minute Between the BM07 5GHz Sensor and SomnoScreen Devices
The respiration rate measured contemporaneously by the BM07 5GHz sensor and the reference device, SomnoScreen, are compared on a second-by-second basis, over the recording duration. The difference between the two respiration rate measurements (the delta) for all 24 subjects' recordings, in all positions, are plotted on a normal distribution chart, giving 10,542 data points. The distribution chart reveals the mean difference between the two devices' measurements and the Standard Deviation (SD). The measure of success is if the 95% (ie 2SD) of the difference in the respiration rate indicated by the two devices (the delta) is less than 5 breaths per minute. This measure is derived from the peer review paper by Lim et al, cited in the References section
Time frame: Recording duration of 2 minutes; measurement made after 45 seconds settling time, for at least 60 seconds
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 5GHz Sensor Spot Respiration Rate | Respiration Rate Accuracy - Mean Difference in Breaths Per Minute Between the BM07 5GHz Sensor and SomnoScreen Devices | 0.28 breaths per minute | Standard Deviation 1.2 |