Hypertension Clinical Trial
Official title:
Calibration of the Cloud DX Pulsewave Health Monitor (PAD-2A) Oscillometric Wrist Cuff Home Blood Pressure Monitor, According to the AAMI/ESH/ISO Universal Standard (ISO 81060-2: AMD_2020) (CCV-4)
The objective of this study is to calibrate the blood pressure measurements of the Pulsewave Health Monitor (PAD-2A) device to be within 5±8 mmHg of the average of the dual-observer measurements via an aneroid sphygmomanometer (reference device), as per the methodology described in the ISO 81060-2: AMD_2020 protocol.
| Status | Recruiting |
| Enrollment | 200 |
| Est. completion date | December 31, 2023 |
| Est. primary completion date | December 31, 2023 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | All |
| Age group | 19 Years and older |
| Eligibility | Inclusion Criteria: - Adults = 19 years of age (minimum 30% male/female) - Wrist circumference between 13.5 cm. - 23 cm. (5.3 in. - 9.1 in.): 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 Exclusion Criteria: - Wrist circumference less than 13.5 cm. (5.3 in.) or greater than 23 cm. (9.1 in) - Hand or body tremors - Irregular heart rhythm (bigeminy, trigeminy, isolated ventricular premature beat (VPB), atrial fibrillation) - Korotkoff sound K5 not audible - 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 |
| Country | Name | City | State |
|---|---|---|---|
| Canada | Horizon Health Network | Saint John |
| Lead Sponsor | Collaborator |
|---|---|
| Cardiovascular Research New Brunswick | Cloud DX Inc., Dalhousie University, Horizon Health Network, New Brunswick Health Research Foundation |
Canada,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Systolic Pressure | Non-invasive Pulsewave Health Monitor (PAD-2A) wrist cuff blood pressure device (mmHg) | From the start of cuff inflation to the end of cuff deflation (approximately 60 seconds) | |
| Primary | Systolic Pressure | Simultaneous auscultatory blood pressure measurements by 2 trained observers | From the start of manual inflation of the upper arm blood pressure cuff to the end of (manual) deflation of the upper arm blood pressure cuff (approximately 30-60 seconds) | |
| Primary | Diastolic Pressure | Non-invasive Pulsewave Health Monitor (PAD-2A) wrist cuff blood pressure device (mmHg) | From the start of cuff inflation to the end of cuff deflation (approximately 60 seconds) | |
| Primary | Diastolic Pressure | Simultaneous auscultatory blood pressure measurements by 2 trained observers | From the start of manual inflation of the upper arm blood pressure cuff to the end of (manual) deflation of the upper arm blood pressure cuff (approximately 30-60 seconds) |
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