Accuracy of Respiration Rate MeasurementNCT02740478
Reassure Device: Measurement Accuracy of Continuous Respiration Rate
An observational study of Accuracy of Respiration Rate Measurement, run by ResMed.
Trial summary
The aim of the trial is to prove that the Reassure10.5 GHz sensor is equivalent in performance to the SomnoScreen Plus RC in indicating the breathing rate of adult subjects over a number of hours when the subjects are lying still or in bed asleep 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 Respiration Rate Measurement
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- May 2015to Jul 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: Quantity 20 volunteer subjects willing to undergo the trial: lying still for 2 hours, following a pre-scripted set on lying positions.
Who may be able to join
- Willing Volunteer
Who cannot join
- Restless leg syndrome
About this study
Official title: A Comparison of the Non-contact Reassure Device Measurement Accuracy of Respiration Rate With SOMNOScreen, When Measured on a Continuous Basis Whilst the Subjects Are Asleep
The aim of the trial is to prove that the Reassure10.5 GHz sensor is equivalent in performance to the SomnoScreen Plus RC in indicating the breathing rate of adult subjects over a number of hours when the subjects are lying still or in bed asleep
Read the detailed description
Each recording comprised at least 2 hours duration. The subject was lying on a bed, wearing the SomnoScreen and with the Reassure on a bed-side table in the recommended position: at arm's length, pointing at the subject's upper torso.
The subject was asked to lie in set positions on the bed for 20 minutes at a time. The data was recorded continuously for the duration of the trial and so encompassed the acts of turning from one position to another and any minor movement made by the subject. If the subject fell asleep during the trial, they were only woken when it came time for the next position change.
Key Duration Remarks Supine >=20minutes Subject Lying on back Prone >=20minutes Subject Lying face down Facing Left >=20minutes Subject's Chest facing Reassure device Facing Right >=20minutes Subject's Back facing Reassure device Foetal Left >=20minutes Subject's Chest facing Reassure device Foetal Right >=20minutes Subject's Back facing Reassure device
- Conditions
- Accuracy of Respiration Rate Measurement
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 |
|---|---|---|
| Volunteers | 20 volunteer subjects, no selection criteria |
What is being measured
The primary outcome is the main question the study is designed to answer.
Respiration Rate Comparability
The respiration rate measured contemporaneously by the Reassure and the reference device, SomnoScreen, are compared on a second-by-second basis, over the whole recording duration. The difference between the two respiration rate measurements (the delta) for all 20 subjects' recordings are plotted on a normal distribution chart, giving 130,000 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: 2 hour recording
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 startMay 2015
- Primary completionJul 2015
- Study completionJul 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 Respiration Rate MeasurementStudies 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 Ltd
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02740478
- Sponsor's protocol ID
- D22105-107
- 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: Device performance validation, only registered with Clinicaltrials.gov as it entailed 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 Comparison of the Non-contact Reassure Device Measurement Accuracy of Respiration Rate With SOMNOScreen, When Measured on a Continuous Basis Whilst the Subjects Are Asleep
- ClinicalTrials.gov ID
- NCT02740478
- Acronym / sponsor ID
- D22105-107
- Conditions
- Accuracy of Respiration Rate Measurement
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- ResMedIndustry (pharma, biotech, devices)
- Study start
- May 2015
- Primary completion
- Jul 2015 (actual)
- Study completion
- Jul 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.
The aim of the trial is to prove that the Reassure10.5 GHz sensor is equivalent in performance to the SomnoScreen Plus RC in indicating the breathing rate of adult subjects over a number of hours when the subjects are lying still or in bed asleep
Detailed description
Each recording comprised at least 2 hours duration. The subject was lying on a bed, wearing the SomnoScreen and with the Reassure on a bed-side table in the recommended position: at arm's length, pointing at the subject's upper torso.
The subject was asked to lie in set positions on the bed for 20 minutes at a time. The data was recorded continuously for the duration of the trial and so encompassed the acts of turning from one position to another and any minor movement made by the subject. If the subject fell asleep during the trial, they were only woken when it came time for the next position change.
Key Duration Remarks Supine >=20minutes Subject Lying on back Prone >=20minutes Subject Lying face down Facing Left >=20minutes Subject's Chest facing Reassure device Facing Right >=20minutes Subject's Back facing Reassure device Foetal Left >=20minutes Subject's Chest facing Reassure device Foetal Right >=20minutes Subject's Back facing Reassure device
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Volunteers | – | –20 volunteer subjects, no selection criteria |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Quantity 20 volunteer subjects willing to undergo the trial: lying still for 2 hours, following a pre-scripted set on lying positions.
Key inclusion criteria (1 listed)
- Willing Volunteer
Key exclusion criteria (1 listed)
- Restless leg syndrome
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 Comparability
Time frame: 2 hour recording
The respiration rate measured contemporaneously by the Reassure and the reference device, SomnoScreen, are compared on a second-by-second basis, over the whole recording duration. The difference between the two respiration rate measurements (the delta) for all 20 subjects' recordings are plotted on a normal distribution chart, giving 130,000 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. Device performance validation, only registered with Clinicaltrials.gov as it entailed human volunteers. No intent to publish
Related trials for Accuracy of Respiration Rate Measurement
Not yet recruiting
Smartphone Camera Measurement of Breathing-Related Heart Rate Variability Compared With ECG in Healthy Adults
Respiratory Sinus Arrhythmia, Heart Rate Variability
Enrolling by invitation
Validation of Respiratory Rate Measurement Accuracy Using a Smartwatch
Respiratory Rate Monitoring
RecruitingObservational study
Accuracy of Smartwatches in Measuring Oxygen Levels in Patients With Pulmonary Hypertension: A Pilot Study
Pulmonary Hypertension
Not yet recruitingObservational study
A Prospective Study of Advanced Diagnostics in People With an Unclear Diagnosis of Cystic Fibrosis
Cystic Fibrosis (CF), CFTR-related Disorders
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 Ltd
Questions about this trial
What is this clinical trial studying?
An observational study of Accuracy of Respiration Rate Measurement, 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 1 inclusion and 1 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 Comparability (time frame: 2 hour recording). 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 NCT02740478, 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.