Ignite Creation Date:
2024-10-26 @ 3:41 PM
Last Modification Date:
2024-10-26 @ 3:41 PM
Study NCT ID:
NCT06614959
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-24
Brief Title:
The Effects of Oscillatory Positive Expiratory Pressure OPEP Therapy in Patients with COPD
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Assessing the Effects of Oscillatory Positive Expiratory Pressure OPEP Therapy on Disease Impact and Respiratory System Dynamics in Patients with COPD a Prospective Non-Pharmacologic Interventional Cohort Study
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The goal of this non-pharmacologic interventional study is to learn if Oscillatory Positive Expiratory Pressure OPEP therapy can improve disease impact and respiratory system dynamics in patients with COPD The main questions it aims to answer are
Is OPEP therapy able to improve the impact of cough symptoms as measured on a validated symptom score Is OPEP therapy able to improve the properties of the lung called reactance as measured by oscillometry
Researchers will compare the results of the same tests performed before and after 4 weeks of OPEP treatment to see if OPEP treatment improves cough symptoms and lung mechanics
Participants with COPD will complete in-person baseline tests and will then receive the smart OPEP device
These participants will then use the smart OPEP device at home at least twice a day for 4 consecutive weeks
Finally these participants will return to complete in-person end-of-study tests
Is OPEP therapy able to improve the impact of cough symptoms as measured on a validated symptom score Is OPEP therapy able to improve the properties of the lung called reactance as measured by oscillometry
Researchers will compare the results of the same tests performed before and after 4 weeks of OPEP treatment to see if OPEP treatment improves cough symptoms and lung mechanics
Participants with COPD will complete in-person baseline tests and will then receive the smart OPEP device
These participants will then use the smart OPEP device at home at least twice a day for 4 consecutive weeks
Finally these participants will return to complete in-person end-of-study tests
Detailed Description:
The objectives of this prospective non-pharmacologic interventional cohort study are to determine the effect of four consecutive weeks of twice-daily or greater OPEP usage among patients with COPD with a chronic bronchitis sputum-producing phenotype on disease impact and on respiratory system dynamics A dose-response effect of OPEP use will also be investigated
We hypothesize that a 4-week period of OPEP therapy among eligible patients with COPD with a chronic bronchitis sputum-producing phenotype will be associated with improved disease impact scores and airway mechanics
We hypothesize that a 4-week period of OPEP therapy among eligible patients with COPD with a chronic bronchitis sputum-producing phenotype will be associated with improved disease impact scores and airway mechanics
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None