Clinical trial NCT01319396: Performance Validation of a Non-contact Breathing Frequency Monitor (Model BM07)
Official title: Performance Validation of a Non-contact Breathing Frequency Monitor (Model BM07)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Unspecified Threat to Breathing
Keywords: breathing rate
Lead sponsor: ResMed
Sponsor class: INDUSTRY
First posted: 2011-03-21
Enrollment: 24
Sex: ALL
Minimum age (years): 10
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: twenty two plus volunteer subjects, distributed on the follwoing parameters: gender balance: 1/3:2/3 or better. age range: aged 10 years through to senior citizens BMI range: 19 to 40+, or wider

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

Eligibility criteria: Inclusion Criteria:

* volunteer
* consent

Exclusion Criteria: none

Primary outcomes:
measure: Respiration Rate Accuracy - Mean Difference in Breaths Per Minute Between the BM07 5GHz Sensor and SomnoScreen Devices
timeFrame: Recording duration of 2 minutes; measurement made after 45 seconds settling time, for at least 60 seconds
Secondary outcomes:
Other outcomes:
Locations:
city: Dublin
country: Ireland
facility: ResMed
Study officials:
affiliation: ResMed
name: Paul D Phillips, MSc, MA
role: PRINCIPAL_INVESTIGATOR
References: