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

NCT04868630 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 80

Last updated 2023-02-21

No results posted yet for this study

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

Interventions

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).

Sponsors & Collaborators

  • Cloud DX Inc.

    collaborator INDUSTRY

  • Horizon Health Network

    collaborator OTHER

  • Atlantic Sleep Center

    collaborator UNKNOWN

  • New Brunswick Health Research Foundation

    collaborator OTHER

  • Dalhousie University

    collaborator OTHER

  • Cardiovascular Research New Brunswick

    lead OTHER

Principal Investigators

  • Graham Bishop, MD, FRCP(C) · Atlantic Sleep Centre

Eligibility

Min Age
19 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-09-10
Primary Completion
2023-12-31
Completion
2023-12-31
FDA Device
Yes

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04868630 on ClinicalTrials.gov