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| ID | Type | Description | Link |
|---|---|---|---|
| STP-PW2-001 | Other Identifier | Health Canada |
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| Name | Class |
|---|---|
| Cloud DX Inc. | INDUSTRY |
| Horizon Health Network | OTHER |
| Atlantic Sleep Center | UNKNOWN |
| New Brunswick Health Research Foundation |
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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.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pulsewave Health Monitor (PAD-2A) Device | Device | 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). |
| Measure | Description | Time Frame |
|---|---|---|
| Breathing rate | Non-invasive Pulsewave Health Monitor (PAD-2A) wrist cuff device (breaths per minute) | 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) | 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) | 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) | Simultaneous measurement with the PAD-2A wrist cuff device from the start of cuff deflation to the end of cuff deflation (approximately 60 seconds). |
| Measure | Description | Time Frame |
|---|---|---|
| Breathing rate | Standard clinical respiratory inductance plethysmography (RIP) belts (breaths per minute) | Simultaneous measurement with the PAD-2A wrist cuff device from the start of cuff deflation to the end of cuff deflation (approximately 60 seconds). |
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Inclusion Criteria:
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
Exclusion Criteria:
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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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Christie Aguiar, PhD | Contact | 506-977-2712 | christie.aguiar@clouddx.com | |
| Keith R. Brunt, PhD | Contact | 506-636-6974 | keith.brunt@dal.ca |
| Name | Affiliation | Role |
|---|---|---|
| Graham Bishop, MD, FRCP(C) | Atlantic Sleep Centre | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Horizon Health Network | Recruiting | Saint John | New Brunswick | Canada |
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| Label | URL |
|---|---|
| Cloud DX device company website. | View source |
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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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| OTHER |
| Dalhousie University | OTHER |
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