Ireland
--:--IST
Active, not recruiting Observational

CareCOPD - COPD Home Monitoring Study

NCT04918095 · tracked via the Priya Life Science USA tracker
Sponsor
Cognita Labs LLC
Phase
Observational
Started
2020-11-09
Last updated
2026-10-21

Condition(s) studied

Chronic Obstructive Pulmonary Disease

Investigational drug(s) / intervention(s)

CareCOPD Platform

CareCOPD Platform: The subjects will be provided with CareCOPD devices for home monitoring of airway impedance, medication use, and symptoms data.

Study summary

This is a pilot study to demonstrate early validation of objective home-monitoring of Chronic obstructive pulmonary disease (COPD) patients by combining accurate and relevant patient data of medication and lung function (lung impedance) through patient-facing devices.

Eligibility

Sex
ALL
Min age
40 Years
Max age
100 Years
Healthy volunteers
No
Inclusion Criteria: Patients who meet all of the following criteria are eligible for enrollment as study participants: * Males and females over the age of 40 years. * physician-diagnosed COPD classified as GOLD 2-3, C-D for at least 1 year. * Using rescue medications at home delivered by a metered-dose inhaler or MDI. * Speak, read, and understand English. * Able to understand study requirements and comply with study procedures. * Ability to operate a smartphone or tablet (for questionnaire and symptoms input). Exclusion Criteria: Subjects who meet any of these criteria are not eligible for enrollment as study participants: * Physically disabled such that they are incapable of performing forced oscillometry test (for airway impedance measurement) * Physically disabled such that they are incapable of using metered-dose inhalers. * Suffer from any visual, hearing, or cognitive impairment that cannot be corrected enough to operate the CareCOPD devices properly. Mild/moderate vision loss and mild hearing loss may be included with appropriate corrective measures that do not affect the device usage. * Suffering from serious uncontrolled medical conditions that may interfere with study conduct. * Continuous home Oxygen use for greater than 16 hours/day. * Inability or unwillingness of the participant to give written informed consent. * Individuals who are not yet adults (infants, children, teenagers) * Pregnant women * Prisoners

Primary outcome measure(s)

  • Percentage of AECOPD — 6 months
    Percentage of AECOPDs detected by CareCOPD platform

Trial sites (1)

FacilityCityRegionStatus
Ventura County Medical Center Ventura California
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04918095 on ClinicalTrials.gov ↗ ← All trials in the USA