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

NCT04868630 | Unknown DMC FDA Device

• 2 other identifiers: RS#: 2020-2908; R#: 100948STP-PW2-001
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Outpatients

Keywords

average breathing rate (breath per minute); vital sign monitoring; telemedicine; non-invasive device

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (1)

• Breathing rate

  Simultaneous measurement with the PAD-2A wrist cuff device from the start of cuff deflation to the end of cuff deflation (approximately 60 seconds).

Study Arms (1)

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

Interventions

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

Outpatients; Atlantic Sleep Centre & SJRH Respiratory Clinic

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Cardiovascular Research New Brunswick: lead
• Cloud DX Inc.: collaborator
• Horizon Health Network: collaborator
• Atlantic Sleep Center: collaborator
• New Brunswick Health Research Foundation: collaborator
• Dalhousie University: collaborator

Study Sites (1)

Horizon Health Network

Saint John, New Brunswick, Canada

RECRUITING

Related Links

• Cloud DX device company website.

Study Officials

• Graham Bishop, MD, FRCP(C)

  Atlantic Sleep Centre

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Christie Aguiar, PhD

CONTACT

506-977-2712; christie.aguiar@clouddx.com

Keith R. Brunt, PhD

CONTACT

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

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 21, 2021
• First Posted: May 3, 2021
• Study Start: September 10, 2021
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2023
• Last Updated: February 21, 2023

Record last verified: 2023-02

Locations

CA (1)