Recruiting

Observational Study

Sponsor:

Cardiovascular Research New Brunswick

Code:

NCT04868630

Conditions

Outpatients

Eligibility Criteria

Sex: All

Age: 19+

Healthy Volunteers: Accepted

Interventions

Pulsewave Health Monitor (PAD-2A) Device

Study Details

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

Study ID

NCT04868630

Start date

Sep 10, 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 13.5cm - 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 Design

Enrollment

80 participants

Anticipated

Interventions and Outcome Measures

Arms

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.

Interventions

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).

Primary outcome measure

  • Breathing rate [ Time Frame: From the start of cuff deflation to the end of cuff deflation (approximately 60 seconds). ]
  • Breathing rate [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: Simultaneous measurement with the PAD-2A wrist cuff device from the start of cuff deflation to the end of cuff deflation (approximately 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, New Brunswick, Canada

More Information

Sponsor

Cardiovascular Research New Brunswick

Last update posted

Feb 21, 2023

Last verified

Feb, 2023

Keywords

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

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.