Performance Validation of a Non-contact Breathing Frequency Monitor (Model BM07)

• Sponsor: ResMed (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01319396
• Collaborator: (none)
• Enrollment: 24
• Location: 1
• Duration (Months): 5
• Patients Per Site Per Month: 4.8

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Unspecified Threat to Breathing

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

Study Design

• Study Type: Observational
• Actual Enrollment: 24 participants
• Observational Model: Case-Only
• Time Perspective: Cross-Sectional
• Official Title: Performance Validation of a Non-contact Breathing Frequency Monitor (Model BM07)
• Study Start Date: Oct 1, 2010
• Actual Primary Completion Date: Dec 1, 2010
• Actual Study Completion Date: Mar 1, 2011

Outcome Measures

Primary Outcome Measures

1. 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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 10 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• volunteer

• consent

Exclusion Criteria: none

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	ResMed	Dublin		Ireland	Dublin 4

Sponsors and Collaborators

• ResMed

Investigators

• Principal Investigator: Paul D Phillips, MSc, MA, ResMed

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: ResMed
• ClinicalTrials.gov Identifier: NCT01319396
• Other Study ID Numbers: BM07_8DTS
• First Posted: Mar 21, 2011
• Last Update Posted: Apr 1, 2021
• Last Verified: Mar 1, 2021

• Keywords provided by ResMed: breathing rate
• Additional relevant MeSH terms: Respiratory Aspiration

Study Results

Participant Flow

Arm/Group Title	5GHz Sensor Spot Respiration Rate
Arm/Group Description	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)
Period Title: Overall Study
STARTED	24
COMPLETED	24
NOT COMPLETED	0

Baseline Characteristics

Arm/Group Title	5.8 GHz Sensor Spot Respiration Rate
Arm/Group Description	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 Participants	24
Age (Count of Participants)
<=18 years	2 8.3%
Between 18 and 65 years	20 83.3%
>=65 years	2 8.3%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	40.6 (14.1)
Sex: Female, Male (Count of Participants)
Female	8 33.3%
Male	16 66.7%
Region of Enrollment (participants) [Number]
United Kingdom	9 37.5%
Ireland	15 62.5%

Outcome Measures

1. Primary Outcome

Title	Respiration Rate Accuracy - Mean Difference in Breaths Per Minute Between the BM07 5GHz Sensor and SomnoScreen Devices
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	5GHz Sensor Spot Respiration Rate
Arm/Group Description	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)
Measure Participants	24
Mean (Standard Deviation) [breaths per minute]	0.28 (1.2)

Adverse Events

Time Frame	adverse events were collected during the 2 minute period that participants were taking part in the evaluation
Arm/Group Title	5.8 GHz Sensor Spot Respiration Rate
Arm/Group Description	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)
All Cause Mortality
	5.8 GHz Sensor Spot Respiration Rate
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	5.8 GHz Sensor Spot Respiration Rate
	Affected / at Risk (%)	# Events
Total	0/24 (0%)
Respiratory, thoracic and mediastinal disorders
General	0/24 (0%)	0
Other (Not Including Serious) Adverse Events
	5.8 GHz Sensor Spot Respiration Rate
	Affected / at Risk (%)	# Events
Total	0/24 (0%)
Respiratory, thoracic and mediastinal disorders
General	0/24 (0%)	0

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.