Recruiting

Observational Study

Sponsor:

Cardiovascular Research New Brunswick

Code:

NCT04869826

Conditions

Hypertension

Eligibility Criteria

Sex: All

Age: 19+

Healthy Volunteers: Accepted

Interventions

Pulsewave Health Monitor (PAD-2A) Device

Study Details

Brief summary:

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.

Conditions

Hypertension

Study ID

NCT04869826

Start date

Jun 15, 2021

Status verified date

Feb, 2023

Completion date

Dec 31, 2023

Anticipated

Primary completion date

Dec 31, 2023

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 19+

Healthy Volunteers: Accepted

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

Study Design

Enrollment

200 participants

Anticipated

Interventions and Outcome Measures

Arms

Outpatients Complicated Hypertension Clinic

This study population consists of approximately 200 adult male and female participants (≥ 19 years of age; minimum 30% male/female). Participants will be recruited from eligible patients who are referred to the Complicated Hypertension Clinic at the Saint John Regional Hospital (SJRH) as well as non-patient participants who are willing to volunteer to consent to participate in the study.

Interventions

Pulsewave Health Monitor (PAD-2A) Device

This is an observational, comparison study of blood pressure measurements. 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 auscultatory blood pressure measurements via an aneroid sphygmomanometer (reference device), as per the ISO 81060-2: AMD_2020 universal protocol.

Primary outcome measure

  • Systolic Pressure [ Time Frame: From the start of cuff inflation to the end of cuff deflation (approximately 60 seconds) ]
  • Systolic Pressure [ Time Frame: 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) ]
  • Diastolic Pressure [ Time Frame: From the start of cuff inflation to the end of cuff deflation (approximately 60 seconds) ]
  • Diastolic Pressure [ Time Frame: 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) ]

Central Contacts and Locations

Central contacts

Christie Aguiar, PhD

506-977-2712christie.aguiar@CloudDX.com

Keith R. Brunt, PhD

506-636-6974keith.brunt@dal.ca

Locations

Horizon Health Network

Recruiting

Saint John, Canada

More Information

Sponsor

Cardiovascular Research New Brunswick

Last update posted

Feb 21, 2023

Last verified

Feb, 2023

Keywords

  • Hypertension
  • Blood pressure
  • Telemedicine
  • Telemonitoring
  • Vital sign monitoring

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Cardiovascular Research New Brunswick on 2023-02-21.