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CareCOPD - COPD Home Monitoring Study

RECRUITINGSponsored by Cognita Labs LLC
Actively Recruiting
SponsorCognita Labs LLC
Started2020-11-09
Est. completion2026-05-31
Eligibility
Age40 Years – 100 Years
Healthy vol.Accepted
Locations1 site

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

Age: 40 Years – 100 YearsHealthy volunteers accepted
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

Conditions2

COPDChronic Obstructive Pulmonary Disease

Locations1 site

Ventura County Medical Center
Ventura, California, 93003
Chris Landon, MD805-652-6075chris.landon@ventura.org

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Trial data from ClinicalTrials.gov. Trial status and eligibility can change — verify directly with the study contact or on ClinicalTrials.gov.

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