Unspecified Threat to BreathingNCT01319396
Performance Validation of a Non-contact Breathing Frequency Monitor (Model BM07)
An observational study of Unspecified Threat to Breathing, run by ResMed at 1 site in Ireland.
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. Read more about this study
- Who is it for?
- Ages 10 years and olderHealthy volunteers can take part
- Conditions the study is for
- Unspecified Threat to Breathing
- How many people
- 24 participants
- Where
- 1 siteIreland
- Study dates
- Oct 2010to Mar 2011
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
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
Who may be able to join
- volunteer
- consent
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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
- Conditions
- Unspecified Threat to Breathing
- Keywords
- breathing rate
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Recording duration of 2 minutes; measurement made after 45 seconds settling time, for at least 60 seconds
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2011 (estimated)
- Study startOct 2010
- Primary completionDec 2010
- Study completionMar 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Unspecified Threat to BreathingStudies of the same condition, open and under way.
- More trials run by ResMedThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- ResMed
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Paul D Phillips, MSc, MA, Principal investigator, ResMed
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01319396
- Sponsor's protocol ID
- BM07_8DTS
- Status last verified
- Mar 2021
- First submitted
- 16 Mar 2011
- Last updated
- 1 Apr 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Performance Validation of a Non-contact Breathing Frequency Monitor (Model BM07)
- ClinicalTrials.gov ID
- NCT01319396
- Acronym / sponsor ID
- BM07_8DTS
- Conditions
- Unspecified Threat to Breathing
- Keywords
- breathing rate
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- ResMedIndustry (pharma, biotech, devices)
- Study start
- Oct 2010
- Primary completion
- Dec 2010 (actual)
- Study completion
- Mar 2011 (actual)
- First posted
- 21 Mar 2011 (estimated)
- Results
- Posted 15 Aug 2011
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 10 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- 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
Key inclusion criteria (2 listed)
- volunteer
- consent
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Respiration Rate Accuracy - Mean Difference in Breaths Per Minute Between the BM07 5GHz Sensor and SomnoScreen Devices
Time frame: 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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Paul D Phillips, MSc, MA principal investigator
ResMed
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Unspecified Threat to Breathing, run by ResMed at 1 site in Ireland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Ireland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 15 Aug 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Respiration Rate Accuracy - Mean Difference in Breaths Per Minute Between the BM07 5GHz Sensor and SomnoScreen Devices (time frame: Recording duration of 2 minutes; measurement made after 45 seconds settling time, for at least 60 seconds). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Apr 2021.