Recruiting

Observational Study

Sponsor:

Cognita Labs LLC

Code:

NCT04918095

Conditions

Chronic Obstructive Pulmonary Disease

Eligibility Criteria

Sex: All

Age: 40 - 70+

Healthy Volunteers: Not accepted

Interventions

CareCOPD Platform

Study Details

Brief 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.

Conditions

Chronic Obstructive Pulmonary Disease

Study ID

NCT04918095

Start date

Nov 9, 2020

Status verified date

Aug, 2024

Completion date

Jul 31, 2026

Anticipated

Primary completion date

May 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 40 - 70+

Healthy Volunteers: Not 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

Study Design

Enrollment

50 participants

Anticipated

Interventions and Outcome Measures

Arms

Moderate-Severe COPD

COPD patients diagnosed GOLD 2- 3, C- D for moderate-severe, poorly controlled

Interventions

CareCOPD Platform

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

Primary outcome measure

  • Percentage of AECOPD [ Time Frame: 6 months ]

Central Contacts and Locations

Central contacts

Rajoshi Biswas, Ph.D.

8325383042rajoshi@cognitalabs.com

Locations

Ventura County Medical Center

Recruiting

Ventura, California, United States, 93003

Contacts

Chris Landon, MD

805-652-6075chris.landon@ventura.org

More Information

Sponsor

Cognita Labs LLC

Last update posted

Aug 22, 2024

Last verified

Aug, 2024

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Cognita Labs LLC on 2024-08-22.