Trial Outcomes & Findings for Performance Validation of a Non-contact Breathing Frequency Monitor (Model BM07) (NCT NCT01319396)
NCT ID: NCT01319396
Last Updated: 2021-04-01
Results Overview
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
COMPLETED
24 participants
Recording duration of 2 minutes; measurement made after 45 seconds settling time, for at least 60 seconds
2021-04-01
Participant Flow
Participant milestones
| Measure |
5GHz 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)
|
|---|---|
|
Overall Study
STARTED
|
24
|
|
Overall Study
COMPLETED
|
24
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Performance Validation of a Non-contact Breathing Frequency Monitor (Model BM07)
Baseline characteristics by cohort
| Measure |
5.8 GHz Sensor Spot Respiration Rate
n=24 Participants
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)
|
|---|---|
|
Age, Categorical
<=18 years
|
2 Participants
n=99 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
20 Participants
n=99 Participants
|
|
Age, Categorical
>=65 years
|
2 Participants
n=99 Participants
|
|
Age, Continuous
|
40.6 years
STANDARD_DEVIATION 14.1 • n=99 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
16 Participants
n=99 Participants
|
|
Region of Enrollment
United Kingdom
|
9 participants
n=99 Participants
|
|
Region of Enrollment
Ireland
|
15 participants
n=99 Participants
|
PRIMARY outcome
Timeframe: Recording duration of 2 minutes; measurement made after 45 seconds settling time, for at least 60 secondsThe 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
Outcome measures
| Measure |
5GHz Sensor Spot Respiration Rate
n=24 Participants
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)
|
|---|---|
|
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
|
Adverse Events
5.8 GHz Sensor Spot Respiration Rate
Serious adverse events
| Measure |
5.8 GHz Sensor Spot Respiration Rate
n=24 participants at risk
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)
|
|---|---|
|
Respiratory, thoracic and mediastinal disorders
General
|
0.00%
0/24 • adverse events were collected during the 2 minute period that participants were taking part in the evaluation
|
Other adverse events
| Measure |
5.8 GHz Sensor Spot Respiration Rate
n=24 participants at risk
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)
|
|---|---|
|
Respiratory, thoracic and mediastinal disorders
General
|
0.00%
0/24 • adverse events were collected during the 2 minute period that participants were taking part in the evaluation
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place