Status:
UNKNOWN
Chronic Obstructive Pulmonary Disease (COPD) Monitoring
Lead Sponsor:
Medtronic BRC
Conditions:
COPD
COPD Exacerbation
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The present feasibility study aims at assessing whether the EMG of respiratory muscles can serve as an objective marker of dyspnea in COPD patients. The study aims also at evaluating the changes in p...
Eligibility Criteria
Inclusion
- Subject must have a clinical diagnosis of COPD
- mMRC (Modified Medical Research Council) Dyspnea Scale Score \> 1
- Subject must be indicated for regular inpatient pulmonary rehabilitation
- Subject must be hyperinflated, defined as residual volume (RV)\>120% of the predicted value, measured by whole body plethysmography
- Subject must be willing to provide Informed Consent for their participation in the study
- Subject must be ≥18 years of age
Exclusion
- Subjects who are unable/unwilling to voluntarily participate in the study
- Subjects who cannot read/write
- Subjects who are dependent on oxygen and/or unfit to wear a mask during sub- maximal constant work rate test (CWRT)
- Subject has congenital heart disease
- Subject has unstable coronary artery disease
- Subject has an active implanted cardiac device (i.e. IPG, ICD)
- Subject has heart failure NYHA 4
- Subject presents any concomitant condition which in the opinion of the investigator would not allow a safe participation in the study
- Subject is legally incompetent
- Subject is pregnant or has suspect to be pregnant
- Subject is enrolled in a concurrent study that may confound the results of this study without documented pre-approval from Medtronic study manager
- BORG scale assessment is evaluated as unreliable due to patient's cognitive condition
Key Trial Info
Start Date :
February 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 1 2022
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT04671888
Start Date
February 1 2021
End Date
November 1 2022
Last Update
December 17 2020
Active Locations (0)
Enter a location and click search to find clinical trials sorted by distance.
No Results Found
We couldn’t find results for the location/zipcode entered or within the selected range. Please check your input or adjust your search.