Status:
TERMINATED
Clinical Feasibility of a Non-invasive Wearable Acoustic Device for Measuring Air Trapping in COPD
Lead Sponsor:
Respira Labs, Inc
Collaborating Sponsors:
Palo Alto Medical Foundation
Conditions:
COPD
COPD Exacerbation
Eligibility:
All Genders
18+ years
Brief Summary
This is a pilot observational study during which the investigators will conduct a longitudinal assessment of air trapping (with up to 2 visits) in 40 patients with COPD and variable degrees of air tra...
Detailed Description
Chronic Obstructive Pulmonary Disease (COPD) is the fourth leading cause of hospitalization in the United States. Exacerbations, a worsening or "flare up" of symptoms cause most COPD hospitalizations....
Eligibility Criteria
Inclusion
- Inclusion criteria for cases (COPD patients) are:
- Men or women over 40 years old.
- Spirometric COPD.
- A history of smoking at least 20 pack-years.
- Exclusion Criteria:
- Inability to perform lung function testing.
- Inability to complete the study and return for follow-up visits.
- Pregnancy.
- A serious and active heart condition, defined by stable or unstable angina, recent myocardial infarction (within the last 2 years), active or decompensated congestive heart failure or cardiomyopathy.
- End-stage liver disease.
- Patients unable to do mild exercise (patients with orthopedic-neurologic problems; patients who have severe heart failure characterized by an ejection fraction of \<20% or by New York Heart Association Class IV disease; patients who should be at complete rest, confined to a bed or chair; or patients for whom physical activity brings on discomfort and for whom symptoms occur at rest).
Exclusion
Key Trial Info
Start Date :
March 1 2022
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
June 1 2023
Estimated Enrollment :
8 Patients enrolled
Trial Details
Trial ID
NCT04450368
Start Date
March 1 2022
End Date
June 1 2023
Last Update
June 18 2023
Active Locations (1)
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1
El Camino Hospital
Mountain View, California, United States, 94040