Accuracy of Measurement of Respiration RateNCT02740504
Reassure Spot Respiration Rate Accuracy Compared to SOMNOScreen
An observational study of Accuracy of Measurement of Respiration Rate, run by ResMed.
Trial summary
A trial conducted within the company with a new non-contact respiration rate (RR) sensor. The device was compared for accuracy in RR measurement with a cleared device, the SOMNOScreen Easy, which uses chest effort bands. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Accuracy of Measurement of Respiration Rate
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- Jan 2015to Mar 2015
- 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 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: 20 persons selected to cover the range of age and BMI of 18 to 45
Who may be able to join
- Greater or equal to 18 years old and less than or equal to 75 years old
- BMI within the range of greater or equal to 18 and less than or equal to 45
Who cannot join
None listed.
About this study
Official title: A Test of the Spot Respiration Rate Accuracy of the New Reassure Device on Human Subjects
A trial conducted within the company with a new non-contact respiration rate (RR) sensor. The device was compared for accuracy in RR measurement with a cleared device, the SOMNOScreen Easy, which uses chest effort bands.
The RR was measured over a short duration on subjects sitting upright in a chair, with the non-contact sensor at various distances from the subject. A total of 20 subjects were tested, from both genders, selected to represent a wide range of age and body mass index
Read the detailed description
The Reassure uses Radio Frequency (RF) waves to detect the small movements of the human body due to respiration. The reference device, the SOMNOScreen, uses chest effort bands. The Reassure is non-contact and so more comfortable and convenient for quick RR measurement, in a similar way that an Infra-Red thermometer is compared to a traditional under-the-tongue mercury thermometer.
The aim is to explore the variations in the human body that could have an effect on the radio reflection from the human torso, and thus affect the potential detection and accuracy of breathing rate. Factors that could affect non-contact RF performance are:
- High Body Mass Index (BMI) could potentially reduce the chest wall movement during breathing, or alter the nature of the breathing.
- Elderly, thin skin (ie pensioner with low BMI) may have less RF reflection.
- Female breast tissue may have an effect on detection or accuracy.
This was tested at a number of distances from the non-contact sensor and also with the subject having a thick comforter (duvet) laid across them.
The test conditions were
- Distances of 0.5 m, 1.0m and 1.5m between the subject and the RF sensor.
- Additional test condition of comforter (duvet) on the subject when the distance from subject to sensor is 1.0 m.
- Each test condition carried out twice.
The use of the comforter in one test condition is to confirm that the RR measurement by the Reassure is unaffected by the thickness of clothing or blankets being worn.
- Keywords
- Respiration rate
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Subjects | All 20 subjects. Selected to have a range of ages (18 to less than 75) and BMI from 18.5 to 45 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Respiration Rate Accuracy
The respiration rate measured contemporaneously by the Reassure 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 20 subjects' recordings, in all positions, are plotted on a normal distribution chart, giving 8,800 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 posted15 Apr 2016 (estimated)
- Study startJan 2015
- Primary completionMar 2015
- Study completionMar 2015
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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Accuracy of Measurement of Respiration RateStudies 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
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- ResMed
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Paul Phillips, MA, MSc, Principal investigator, ResMed Sensor Technologies
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02740504
- Sponsor's protocol ID
- D22105-106
- Status last verified
- Mar 2021
- First submitted
- 12 Apr 2016
- Last updated
- 2 Apr 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No: Trial is for device performance validation and only recorded with Clinical Trials.gov as it involved human volunteers. No intent to publish
Publications
Lim WS, Carty SM, Macfarlane JT, Anthony RE, Christian J, Dakin KS, Dennis PM. Respiratory rate measurement in adults--how reliable is it? Respir Med. 2002 Jan;96(1):31-3. doi: 10.1053/rmed.2001.1203.
PubMed 11863207
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Test of the Spot Respiration Rate Accuracy of the New Reassure Device on Human Subjects
- ClinicalTrials.gov ID
- NCT02740504
- Acronym / sponsor ID
- D22105-106
- Keywords
- Respiration rate
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- ResMedIndustry (pharma, biotech, devices)
- Study start
- Jan 2015
- Primary completion
- Mar 2015 (actual)
- Study completion
- Mar 2015 (actual)
- First posted
- 15 Apr 2016 (estimated)
- Results
- Posted 2 Apr 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A trial conducted within the company with a new non-contact respiration rate (RR) sensor. The device was compared for accuracy in RR measurement with a cleared device, the SOMNOScreen Easy, which uses chest effort bands.
The RR was measured over a short duration on subjects sitting upright in a chair, with the non-contact sensor at various distances from the subject. A total of 20 subjects were tested, from both genders, selected to represent a wide range of age and body mass index
Detailed description
The Reassure uses Radio Frequency (RF) waves to detect the small movements of the human body due to respiration. The reference device, the SOMNOScreen, uses chest effort bands. The Reassure is non-contact and so more comfortable and convenient for quick RR measurement, in a similar way that an Infra-Red thermometer is compared to a traditional under-the-tongue mercury thermometer.
The aim is to explore the variations in the human body that could have an effect on the radio reflection from the human torso, and thus affect the potential detection and accuracy of breathing rate. Factors that could affect non-contact RF performance are:
- High Body Mass Index (BMI) could potentially reduce the chest wall movement during breathing, or alter the nature of the breathing.
- Elderly, thin skin (ie pensioner with low BMI) may have less RF reflection.
- Female breast tissue may have an effect on detection or accuracy.
This was tested at a number of distances from the non-contact sensor and also with the subject having a thick comforter (duvet) laid across them.
The test conditions were
- Distances of 0.5 m, 1.0m and 1.5m between the subject and the RF sensor.
- Additional test condition of comforter (duvet) on the subject when the distance from subject to sensor is 1.0 m.
- Each test condition carried out twice.
The use of the comforter in one test condition is to confirm that the RR measurement by the Reassure is unaffected by the thickness of clothing or blankets being worn.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Subjects | – | –All 20 subjects. Selected to have a range of ages (18 to less than 75) and BMI from 18.5 to 45 |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- 20 persons selected to cover the range of age and BMI of 18 to 45
Key inclusion criteria (2 listed)
- Greater or equal to 18 years old and less than or equal to 75 years old
- BMI within the range of greater or equal to 18 and less than or equal to 45
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
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 Reassure 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 20 subjects' recordings, in all positions, are plotted on a normal distribution chart, giving 8,800 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 2 Apr 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 11863207Lim WS, Carty SM, Macfarlane JT, Anthony RE, Christian J, Dakin KS, Dennis PM. Respiratory rate measurement in adults--how reliable is it? Respir Med. 2002 Jan;96(1):31-3. doi: 10.1053/rmed.2001.1203.
- Individual participant dataSharing planned: No. Trial is for device performance validation and only recorded with Clinical Trials.gov as it involved human volunteers. No intent to publish
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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 Phillips, MA, MSc principal investigator
ResMed Sensor Technologies
Questions about this trial
What is this clinical trial studying?
An observational study of Accuracy of Measurement of Respiration Rate, run by ResMed.
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 2 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
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 2 Apr 2021). 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 (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?
On the ClinicalTrials.gov record for NCT02740504, which also lists 1 linked publication.
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 2 Apr 2021.