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) |
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Terminated |
NCT04591808 -
Efficacy and Safety of Atorvastatin + Perindopril Fixed-Dose Combination S05167 in Adult Patients With Arterial Hypertension and Dyslipidemia
|
Phase 3 | |
| Recruiting |
NCT04515303 -
Digital Intervention Participation in DASH
|
||
| Completed |
NCT05433233 -
Effects of Lifestyle Walking on Blood Pressure in Older Adults With Hypertension
|
N/A | |
| Completed |
NCT05491642 -
A Study in Male and Female Participants (After Menopause) With Mild to Moderate High Blood Pressure to Learn How Safe the Study Treatment BAY3283142 is, How it Affects the Body and How it Moves Into, Through and Out of the Body After Taking Single and Multiple Doses
|
Phase 1 | |
| Completed |
NCT03093532 -
A Hypertension Emergency Department Intervention Aimed at Decreasing Disparities
|
N/A | |
| Completed |
NCT04507867 -
Effect of a NSS to Reduce Complications in Patients With Covid-19 and Comorbidities in Stage III
|
N/A | |
| Completed |
NCT05529147 -
The Effects of Medication Induced Blood Pressure Reduction on Cerebral Hemodynamics in Hypertensive Frail Elderly
|
||
| Recruiting |
NCT05976230 -
Special Drug Use Surveillance of Entresto Tablets (Hypertension)
|
||
| Recruiting |
NCT06363097 -
Urinary Uromodulin, Dietary Sodium Intake and Ambulatory Blood Pressure in Patients With Chronic Kidney Disease
|
||
| Completed |
NCT06008015 -
A Study to Evaluate the Pharmacokinetics and the Safety After Administration of "BR1015" and Co-administration of "BR1015-1" and "BR1015-2" Under Fed Conditions in Healthy Volunteers
|
Phase 1 | |
| Completed |
NCT05387174 -
Nursing Intervention in Two Risk Factors of the Metabolic Syndrome and Quality of Life in the Climacteric Period
|
N/A | |
| Completed |
NCT04082585 -
Total Health Improvement Program Research Project
|
||
| Recruiting |
NCT05121337 -
Groceries for Black Residents of Boston to Stop Hypertension Among Adults Without Treated Hypertension
|
N/A | |
| Withdrawn |
NCT04922424 -
Mechanisms and Interventions to Address Cardiovascular Risk of Gender-affirming Hormone Therapy in Trans Men
|
Phase 1 | |
| Active, not recruiting |
NCT05062161 -
Sleep Duration and Blood Pressure During Sleep
|
N/A | |
| Not yet recruiting |
NCT05038774 -
Educational Intervention for Hypertension Management
|
N/A | |
| Completed |
NCT05087290 -
LOnger-term Effects of COVID-19 INfection on Blood Vessels And Blood pRessure (LOCHINVAR)
|
||
| Completed |
NCT05621694 -
Exploring Oxytocin Response to Meditative Movement
|
N/A | |
| Completed |
NCT05688917 -
Green Coffee Effect on Metabolic Syndrome
|
N/A | |
| Recruiting |
NCT05575453 -
OPTIMA-BP: Empowering PaTients in MAnaging Blood Pressure
|
N/A |