OutpatientsCCV-3NCT04868630
Calibration of the Average Breathing Rate Measurement of the Cloud DX Pulsewave Health Monitor (PAD-2A) Device (CCV-3)
An observational study of Outpatients, run by Cardiovascular Research New Brunswick at 1 site in Canada.
Trial summary
The purpose of this study is to calibrate the average breathing rate measurement of the PAD-2A device to be within ±2 breaths per minute of clinical capnography breathing rate measurements. Read more about this study
- Who is it for?
- Ages 19 years and olderHealthy volunteers can take part
- Conditions the study is for
- Outpatients
- What is being tested?
- Pulsewave Health Monitor (PAD-2A) Device
- Type of treatment
- Medical device
- How many people
- 80 participants
- Where
- 1 siteCanada
- Study dates
- 10 Sep 2021to 31 Dec 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
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 19 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: For the PAD-2A device calibration phase of the study, we will recruit and consent approximately 80 adult male and female patient participants (≥ 19 years of age; minimum 30% male/female) who are referred to the Atlantic Sleep Centre or the Respiratory Clinic at the Saint John Regional Hospital (SJRH) and who are willing to volunteer to participate in the study. Eligibility of participants will be determined based on the inclusion/exclusion criteria of the study, as described below.
Who may be able to join
- Adults ≥ 19 years of age (minimum 30% male/female)
- Wrist circumference between 13.5cm - 23cm (5.3 in. - 9.1in.)
- Specifically for this test device, the wrist size of the consented participants will be distributed accordingly for a Gaussian distribution:
- Lowest Octile: ≥ 13.5cm to < 14.7cm Lower Quarter: ≥ 13.5cm to < 15.9cm Lower-Middle Quarter: ≥ 15.9cm to < 18.3cm Upper-Middle Quarter: ≥ 18.3cm to < 20.7cm Upper Quarter: ≥ 20.7cm to ≤ 23.0cm Highest Octile: ≥ 21.9cm to ≤ 23.0cm
- Willing to volunteer to participate and to sign the study specific informed consent form
Who cannot join
- Wrist circumference less than 13.5cm (5.3 in.) or greater than 23cm (9.1 in)
- Hand or body tremors
- Canadian Cardiovascular Society (CCS) grade III or IV angina pectoris (chest pain)
- Unexplained shortness of breath at rest
- History of seizures (except childhood febrile seizures)
- Epilepsy
Show all 10Show fewer
- History of unexplained syncope (fainting)
- Pregnant
- A musculoskeletal disorder that prevents a non-invasive device to be inflated/deflated on the arm
- Unwilling to volunteer to participate and to sign the study specific informed consent form
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
Horizon Health Network
Saint John, New Brunswick
About this study
The purpose of this study is to calibrate the average breathing rate measurement of the PAD-2A device to be within ±2 breaths per minute of clinical capnography breathing rate measurements.
Read the detailed description
The plan for this study is to calibrate the average breathing rate measurement of the PAD-2A device with the breathing rate measurement of a standard clinical capnography device. The data will be collected and analyzed in order to calibrate the PAD-2A device via the capnography measures by adjusting the device algorithm for the breathing rate measurements to be within ±2 breaths per minute. Additionally, the secondary objective of this study is to compare the clinical standard respiratory rate measurement of capnography with the respiratory rate measurements of other standard clinical respiratory devices (i.e. nasal pressure transducer, thermistor, and the respiratory inductance plethysmography (RIP) belts of the chest and abdomen).
- Conditions
- Outpatients
- Being tested
- Pulsewave Health Monitor (PAD-2A) Device
- Keywords
- average breathing rate (breath per minute), vital sign monitoring, telemedicine, non-invasive device
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pulsewave Health Monitor (PAD-2A) DeviceDevice
This is an observational study of the average breathing rate measurement of a non-invasive wrist cuff device. The purpose of this study is to calibrate the average breathing rate measurement of the Pulsewave Health Monitor (PAD-2A) wrist cuff device with the breathing rate measurement of a standard clinical capnography device. Additionally, we will also compare the average breathing rate measurement of the capnography device with other standard clinical respiratory devices (i.e. nasal pressure transducer, thermistor, and respiratory inductance plethysmography (RIP) belts of the chest and abdomen).
| Study group | Role | What they receive |
|---|---|---|
| Outpatients; Atlantic Sleep Centre & SJRH Respiratory Clinic | The study population consists of approximately 80 adult, outpatient participants recruited from the Atlantic Sleep Centre and the Respiratory Clinic at the Horizon Health Network, Saint John Regional Hospital. Receives: Device: Pulsewave Health Monitor (PAD-2A) Device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Breathing rate
Non-invasive Pulsewave Health Monitor (PAD-2A) wrist cuff device (breaths per minute)
Measured: From the start of cuff deflation to the end of cuff deflation (approximately 60 seconds).
Breathing rate
Standard clinical capnograph device via nasal cannula (breaths per minute)
Measured: Simultaneous measurement with the PAD-2A wrist cuff device from the start of cuff deflation to the end of cuff deflation (approximately 60 seconds).
Breathing rate
Standard clinical nasal pressure transducer via nasal cannula (breaths per minute)
Measured: Simultaneous measurement with the PAD-2A wrist cuff device from the start of cuff deflation to the end of cuff deflation (approximately 60 seconds).
Breathing rate
Standard clinical thermistor via nasal cannula (breaths per minute)
Measured: Simultaneous measurement with the PAD-2A wrist cuff device from the start of cuff deflation to the end of cuff deflation (approximately 60 seconds).
Secondary outcomes (1)
Breathing rate
Standard clinical respiratory inductance plethysmography (RIP) belts (breaths per minute)
Measured: Simultaneous measurement with the PAD-2A wrist cuff device from the start of cuff deflation to the end of cuff deflation (approximately 60 seconds).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2021
- Study start10 Sep 2021
- Primary completion31 Dec 2023 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OutpatientsStudies of the same condition, open and under way.
- 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
- Prospective
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cardiovascular Research New Brunswick
- Sponsor type
- University, hospital or other
- Collaborators
- Cloud DX Inc., Horizon Health Network, Atlantic Sleep Center, New Brunswick Health Research Foundation, Dalhousie University
- Responsible party
- Sponsor
- Investigators
- Graham Bishop, MD, FRCP(C), Principal investigator, Atlantic Sleep Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04868630
- Sponsor's protocol ID
- RS#: 2020-2908; R#: 100948
- Other IDs
- STP-PW2-001
- Acronym
- CCV-3
- Status last verified
- Feb 2023
- First submitted
- 21 Apr 2021
- Last updated
- 21 Feb 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided: Currently, the clinical research group is undecided regarding individual participant data (IPD) sharing with other researchers upon completion of this study, although it is acknowledged that the practice of data sharing among scientists, clinicians, and other professionals is of increasing importance, particularly for transparency in clinical research studies.
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Calibration of the Average Breathing Rate Measurement of the Cloud DX Pulsewave Health Monitor (PAD-2A) Device (CCV-3)
- ClinicalTrials.gov ID
- NCT04868630
- Acronym / sponsor ID
- CCV-3 / RS#: 2020-2908; R#: 100948
- Conditions
- Outpatients
- Keywords
- average breathing rate (breath per minute), vital sign monitoring, telemedicine, non-invasive device
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Cardiovascular Research New BrunswickUniversity, hospital or other
- Collaborators
- Cloud DX Inc., Horizon Health Network, Atlantic Sleep Center, New Brunswick Health Research Foundation, Dalhousie University
- Study start
- 10 Sep 2021 (actual)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 3 May 2021 (actual)
- Results
- Not posted in the source record
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 calibrate the average breathing rate measurement of the PAD-2A device to be within ±2 breaths per minute of clinical capnography breathing rate measurements.
Detailed description
The plan for this study is to calibrate the average breathing rate measurement of the PAD-2A device with the breathing rate measurement of a standard clinical capnography device. The data will be collected and analyzed in order to calibrate the PAD-2A device via the capnography measures by adjusting the device algorithm for the breathing rate measurements to be within ±2 breaths per minute. Additionally, the secondary objective of this study is to compare the clinical standard respiratory rate measurement of capnography with the respiratory rate measurements of other standard clinical respiratory devices (i.e. nasal pressure transducer, thermistor, and the respiratory inductance plethysmography (RIP) belts of the chest and abdomen).
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Outpatients; Atlantic Sleep Centre & SJRH Respiratory Clinic | – | Device: Pulsewave Health Monitor (PAD-2A) DeviceThe study population consists of approximately 80 adult, outpatient participants recruited from the Atlantic Sleep Centre and the Respiratory Clinic at the Horizon Health Network, Saint John Regional Hospital. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- For the PAD-2A device calibration phase of the study, we will recruit and consent approximately 80 adult male and female patient participants (≥ 19 years of age; minimum 30% male/female) who are referred to the Atlantic Sleep Centre or the Respiratory Clinic at the Saint John Regional Hospital (SJRH) and who are willing to volunteer to participate in the study. Eligibility of participants will be determined based on the inclusion/exclusion criteria of the study, as described below.
Key inclusion criteria (5 listed)
- Adults ≥ 19 years of age (minimum 30% male/female)
- Wrist circumference between 13.5cm - 23cm (5.3 in. - 9.1in.)
- Lowest Octile: ≥ 13.5cm to < 14.7cm Lower Quarter: ≥ 13.5cm to < 15.9cm Lower-Middle Quarter: ≥ 15.9cm to < 18.3cm Upper-Middle Quarter: ≥ 18.3cm to < 20.7cm Upper Quarter: ≥ 20.7cm to ≤ 23.0cm Highest Octile: ≥ 21.9cm to ≤ 23.0cm
- Willing to volunteer to participate and to sign the study specific informed consent form
Key exclusion criteria (10 listed)
- Wrist circumference less than 13.5cm (5.3 in.) or greater than 23cm (9.1 in)
- Hand or body tremors
- Canadian Cardiovascular Society (CCS) grade III or IV angina pectoris (chest pain)
- Unexplained shortness of breath at rest
- History of seizures (except childhood febrile seizures)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pulsewave Health Monitor (PAD-2A) DeviceThis is an observational study of the average breathing rate measurement of a non-invasive wrist cuff device. The purpose of this study is to calibrate the average breathing rate measurement of the Pulsewave Health Monitor (PAD-2A) wrist cuff device with the breathing rate measurement of a standard clinical capnography device. Additionally, we will also compare the average breathing rate measurement of the capnography device with other standard clinical respiratory devices (i.e. nasal pressure transducer, thermistor, and respiratory inductance plethysmography (RIP) belts of the chest and abdomen). | Device | Outpatients; Atlantic Sleep Centre & SJRH Respiratory Clinic |
Primary outcome
Breathing rate
Time frame: From the start of cuff deflation to the end of cuff deflation (approximately 60 seconds).
Non-invasive Pulsewave Health Monitor (PAD-2A) wrist cuff device (breaths per minute)
Breathing rate
Time frame: Simultaneous measurement with the PAD-2A wrist cuff device from the start of cuff deflation to the end of cuff deflation (approximately 60 seconds).
Standard clinical capnograph device via nasal cannula (breaths per minute)
Breathing rate
Time frame: Simultaneous measurement with the PAD-2A wrist cuff device from the start of cuff deflation to the end of cuff deflation (approximately 60 seconds).
Standard clinical nasal pressure transducer via nasal cannula (breaths per minute)
Breathing rate
Time frame: Simultaneous measurement with the PAD-2A wrist cuff device from the start of cuff deflation to the end of cuff deflation (approximately 60 seconds).
Standard clinical thermistor via nasal cannula (breaths per minute)
1 secondary outcome
Breathing rate
Time frame: Simultaneous measurement with the PAD-2A wrist cuff device from the start of cuff deflation to the end of cuff deflation (approximately 60 seconds).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2023.
- Cloud DX device company website.Link provided by the sponsor.
- Individual participant dataSharing planned: Undecided. Currently, the clinical research group is undecided regarding individual participant data (IPD) sharing with other researchers upon completion of this study, although it is acknowledged that the practice of data sharing among scientists, clinicians, and other professionals is of increasing importance, particularly for transparency in clinical research studies.
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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.
Graham Bishop, MD, FRCP(C) principal investigator
Atlantic Sleep Centre
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 Outpatients, run by Cardiovascular Research New Brunswick at 1 site in Canada.
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 5 inclusion and 10 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: status not confirmed, as of the sponsor's last update on 21 Feb 2023. 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 Canada. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Christie Aguiar, PhD (506-977-2712, christie.aguiar@clouddx.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Breathing rate (time frame: From the start of cuff deflation to the end of cuff deflation (approximately 60 seconds).). The study lists 4 primary outcomes in all. 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 21 Feb 2023.