RecruitingNot ApplicableNCT06614959

The Effects of Oscillatory Positive Expiratory Pressure (OPEP) Therapy in Patients With COPD

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

Sponsor

McGill University Health Centre/Research Institute of the McGill University Health Centre

Enrollment

32 participants

Start Date

May 22, 2025

Study Type

INTERVENTIONAL

Conditions

COPD

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.

Eligibility

Min Age: 40 Years

Inclusion Criteria6

Males and females 40 years of age or more
Former/current smokers with a cigarette smoking history for 10 or more pack-years
Physician diagnosis of COPD previously confirmed by spirometry (FEV1/FVC less than 0.7) with 'mild' to 'very severe' (i.e. GOLD 1-4) COPD
Chronic bronchitis phenotype: Sputum production or presence of productive cough greater than 2 days/week in the last 3 months for at least 2 consecutive years, or presence of cough and phlegm almost every day or several times per week
Ability to participate without supplemental oxygen during all oscillometry testing
Ability to provide informed consent

Exclusion Criteria5

No COPD diagnosis
Bronchiectasis, cystic fibrosis, or any other known suppurative acute/chronic lung disease as the principal respiratory condition
Physician-diagnosed exacerbation and/or hospitalization for pulmonary symptoms in the 4 weeks preceding baseline testing
Current use of OPEP, or any use of OPEP in the 4 weeks preceding baseline testing
Current or recent participation in a standard Pulmonary Rehabilitation program in the 4 weeks preceding baseline testing or during the study

Interventions

DEVICEOscillatory Positive Expiratory Pressure (OPEP) Therapy

The smart OPEP device is a standard OPEP device equipped with an additional detachable sensor that collects diagnostic information on the total elapsed time of OPEP use, the pressure generated during use, frequency and amplitude of pressure oscillations, respiratory information (inhalations/exhalation number/time), and sum of all oscillations with a pressure over 1 centimeter of water (cmH2O), all of which will inform the duration and quality of home use.