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PEP Buddy in Pulmonary Rehabilitation

RECRUITINGN/ASponsored by VA Office of Research and Development
Actively Recruiting
PhaseN/A
SponsorVA Office of Research and Development
Started2026-07-16
Est. completion2030-07-29
Eligibility
Age40 Years – 89 Years
Healthy vol.Accepted
Locations2 sites
View on ClinicalTrials.gov →

NCT07404826

Summary

In this study, the investigators will test Veterans with COPD in Pulmonary Rehabilitation. Between two groups, the investigators will give one group a device that assists with breathing and symptoms and the other receives a 'sham' device which does not provide these benefits. The investigators will test to see if the symptoms and exercise capacity of the group who receives this device improves faster in Pulmonary Rehabilitation and has longer lasting benefits after the end of Pulmonary Rehabilitation.

Eligibility

Age: 40 Years – 89 YearsHealthy volunteers accepted
Inclusion Criteria:

* Veteran
* Referral to Pulmonary Rehabilitation for COPD
* FEV1 \<80% predicted
* Participants must be able to exercise on 4L/m nasal cannula O2

Exclusion Criteria:

* Those deemed by the study personnel to have a lung disease other than COPD impacting their daily dyspnea
* Those that are unable to perform study procedures or are unwilling or unable to use PEP Buddy
* Those that have a component of lung disease driven by aspiration or neurological conditions affecting the face or oropharynx
* Those with a life expectancy of \<1 year
* Those with a known surgical intervention that will require a prolonged recovery in the year after enrollment
* Those with a malignancy beyond Stage I or non-melanoma skin cancer
* Those shown shown to have memory loss of MOCA testing

Conditions1

COPD

Locations2 sites

Cincinnati VA Medical Center, Cincinnati, OH
Cincinnati, Ohio, 45220-2213
Robert M Burkes, MD MS(724) 730-3862robert.burkes@va.gov
Louis Stokes VA Medical Center, Cleveland, OH
Cleveland, Ohio, 44106-1702
Frank Jacono, MD216-791-3800frank.jacono@va.gov

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Trial data from ClinicalTrials.gov. Trial status and eligibility can change — verify directly with the study contact or on ClinicalTrials.gov.

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