Calibration of the Average Breathing Rate Measurement of the Cloud DX Pulsewave Health Monitor (PAD-2A) Device (CCV-3) (CCV-3)

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.

Study Overview

• Status: Recruiting
• Conditions: Outpatients
• Intervention / Treatment: Device: Pulsewave Health Monitor (PAD-2A) Device

Detailed Description

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).

• Study Type: Observational
• Enrollment (Anticipated): 80

Contacts and Locations

• Study Contact: Name: Christie Aguiar, PhD; Phone Number: 506-977-2712; Email: christie.aguiar@clouddx.com

Study Locations

• Canada
  • New Brunswick
    • Saint John, New Brunswick, Canada
      • Recruiting
      • Horizon Health Network

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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.

Description

Inclusion Criteria:

• Adults ≥ 19 years of age (minimum 30% male/female)

• Wrist circumference between 13.5cm - 23cm (5.3 in. - 9.1in.)

  • 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 13.5cm (5.3 in.) or greater than 23cm (9.1 in)
• Hand or body tremors
• Canadian Cardiovascular Society (CCS) grade III or IV angina pectoris (chest pain)
• Unexplained shortness of breath at rest
• History of seizures (except childhood febrile seizures)
• Epilepsy
• History of unexplained syncope (fainting)
• 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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

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.

Device: Pulsewave Health Monitor (PAD-2A) 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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).

Secondary Outcome Measures

Outcome Measure	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).

Collaborators and Investigators

• Sponsor: Cardiovascular Research New Brunswick
• Collaborators: Dalhousie University; Horizon Health Network; Cloud DX Inc.; New Brunswick Health Research Foundation; Atlantic Sleep Center
• Investigators: Principal Investigator: Graham Bishop, MD, FRCP(C), Atlantic Sleep Centre

Publications and helpful links

Helpful Links

• Cloud DX device company website.

Study record dates

Study Major Dates

• Study Start (Actual): September 10, 2021
• Primary Completion (Anticipated): December 31, 2023
• Study Completion (Anticipated): December 31, 2023

Study Registration Dates

• First Submitted: April 21, 2021
• First Submitted That Met QC Criteria: April 27, 2021
• First Posted (Actual): May 3, 2021

Study Record Updates

• Last Update Posted (Estimate): February 20, 2023
• Last Update Submitted That Met QC Criteria: February 16, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Keywords: telemedicine; non-invasive device; average breathing rate (breath per minute); vital sign monitoring
• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Respiration Disorders; Respiratory Aspiration
• Other Study ID Numbers: RS#: 2020-2908; R#: 100948; STP-PW2-001 (Other Identifier: Health Canada)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No