HypertensionNCT04869826
Calibration of a Wrist Cuff Blood Pressure Device, According to the AAMI/ESH/ISO Universal Standard
An observational study of Hypertension, run by Cardiovascular Research New Brunswick at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hypertension
- What is being tested?
- Pulsewave Health Monitor (PAD-2A) Device
- Type of treatment
- Medical device
- How many people
- 200 participants
- Where
- 1 siteCanada
- Study dates
- 15 Jun 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 this study, we will recruit and consent approximately 200 adult male and female patient participants (≥ 19 years of age; minimum 30% male/female) who are referred to the Complicated Hypertension Clinic at the Saint John Regional Hospital (SJRH) and non-patient participants who are willing to volunteer to consent to participate in the study. Eligibility of participants for this study is based on the inclusion and exclusion criteria as per the ISO 81060-2: AMD_2020 protocol, as described below.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed description
The plan for this study is to calibrate the blood pressure measurements of the PAD-2A device with the dual-observer blood pressure measurements via an aneroid sphygmomanometer (reference device), as per the ISO 81060-2: AMD_2020 protocol. The data will be collected and analyzed in order to calibrate the PAD-2A device blood pressure measurements to be within 5±8 mmHg of the average of the dual-observer auscultatory blood pressure measurements by adjusting the device algorithm.
- Conditions
- Hypertension
- Being tested
- Pulsewave Health Monitor (PAD-2A) Device
- Keywords
- Hypertension, Blood pressure, Telemedicine, Telemonitoring, Vital sign monitoring
- Medical subject headings
- Hypertension
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, 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. 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.
Systolic Pressure
Non-invasive Pulsewave Health Monitor (PAD-2A) wrist cuff blood pressure device (mmHg)
Measured: From the start of cuff inflation to the end of cuff deflation (approximately 60 seconds)
Systolic Pressure
Simultaneous auscultatory blood pressure measurements by 2 trained observers
Measured: 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
Non-invasive Pulsewave Health Monitor (PAD-2A) wrist cuff blood pressure device (mmHg)
Measured: From the start of cuff inflation to the end of cuff deflation (approximately 60 seconds)
Diastolic Pressure
Simultaneous auscultatory blood pressure measurements by 2 trained observers
Measured: 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)
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 start15 Jun 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 HypertensionStudies 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
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cardiovascular Research New Brunswick
- Sponsor type
- University, hospital or other
- Collaborators
- Cloud DX Inc., Horizon Health Network, New Brunswick Health Research Foundation, Dalhousie University
- Responsible party
- Sponsor
- Investigators
- Martin MacKinnon, MD, FRCP(C), Principal investigator, Complicated Hypertension Clinic, Saint John Regional Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04869826
- Sponsor's protocol ID
- RS#: 2021-3003; R#: 101246
- Other IDs
- STP-PW2-002
- Status last verified
- Feb 2023
- First submitted
- 28 Apr 2021
- Last updated
- 21 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided: Currently, the clinical research group is undecided regarding individual participant data (IDP) 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 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)
- ClinicalTrials.gov ID
- NCT04869826
- Acronym / sponsor ID
- RS#: 2021-3003; R#: 101246
- Conditions
- Hypertension
- Keywords
- Hypertension, Blood pressure, Telemedicine, Telemonitoring, Vital sign monitoring
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Cardiovascular Research New BrunswickUniversity, hospital or other
- Collaborators
- Cloud DX Inc., Horizon Health Network, New Brunswick Health Research Foundation, Dalhousie University
- Study start
- 15 Jun 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 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.
Detailed description
The plan for this study is to calibrate the blood pressure measurements of the PAD-2A device with the dual-observer blood pressure measurements via an aneroid sphygmomanometer (reference device), as per the ISO 81060-2: AMD_2020 protocol. The data will be collected and analyzed in order to calibrate the PAD-2A device blood pressure measurements to be within 5±8 mmHg of the average of the dual-observer auscultatory blood pressure measurements by adjusting the device algorithm.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Outpatients Complicated Hypertension Clinic | – | Device: Pulsewave Health Monitor (PAD-2A) DeviceThis 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. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- For this study, we will recruit and consent approximately 200 adult male and female patient participants (≥ 19 years of age; minimum 30% male/female) who are referred to the Complicated Hypertension Clinic at the Saint John Regional Hospital (SJRH) and non-patient participants who are willing to volunteer to consent to participate in the study. Eligibility of participants for this study is based on the inclusion and exclusion criteria as per the ISO 81060-2: AMD_2020 protocol, as described below.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (7 listed)
- 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
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, 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. | Device | Outpatients Complicated Hypertension Clinic |
Primary outcome
Systolic Pressure
Time frame: From the start of cuff inflation to the end of cuff deflation (approximately 60 seconds)
Non-invasive Pulsewave Health Monitor (PAD-2A) wrist cuff blood pressure device (mmHg)
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)
Simultaneous auscultatory blood pressure measurements by 2 trained observers
Diastolic Pressure
Time frame: From the start of cuff inflation to the end of cuff deflation (approximately 60 seconds)
Non-invasive Pulsewave Health Monitor (PAD-2A) wrist cuff blood pressure device (mmHg)
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)
Simultaneous auscultatory blood pressure measurements by 2 trained observers
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 (IDP) 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.
Martin MacKinnon, MD, FRCP(C) principal investigator
Complicated Hypertension Clinic, Saint John Regional Hospital
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 Hypertension, 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 7 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?
Systolic Pressure (time frame: From the start of cuff inflation 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; AzTrials last refreshed its copy on 7 Nov 2026.