NCT07404826Recruiting
PEP Buddy in Pulmonary Rehabilitation
A Randomized, Sham Controlled Clinical Trial to Assess the Effectiveness of a Positive End Expiratory Device for Accelerating and Maintaining Pulmonary Rehabilitation Gains
Source: ClinicalTrials.gov · Last updated 24 Jul 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 120 (estimated)
- First submitted
- 4 Feb 2026
- Start date
- 16 Jul 2026
- Primary completion date
- 29 Jul 2030
- Lead sponsor
- VA Office of Research and Development
- Diseases
- COPD
- NCT number
- NCT07404826
What you commit to
- Study type: Interventional
- Planned participants: 120
- From 16 Jul 2026 to the primary completion date, 29 Jul 2030
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Those with a known surgical intervention that will require a prolonged recovery in the year after enrollment
Other illness
- Those deemed by the study personnel to have a lung disease other than COPD impacting their daily dyspnea
- Those that have a component of lung disease driven by aspiration or neurological conditions affecting the face or oropharynx
- Those with a malignancy beyond Stage I or non-melanoma skin cancer
Other
- Those that are unable to perform study procedures or are unwilling or unable to use PEP Buddy
- Those with a life expectancy of \<1 year
- Those shown shown to have memory loss of MOCA testing
Who the study is looking for
- Veteran
- Referral to Pulmonary Rehabilitation for COPD
- FEV1 \<80% predicted
- Participants must be able to exercise on 4L/m nasal cannula O2
Age in the registry: 40 years to 89 years · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Cincinnati VA Medical Center, Cincinnati, OH Coordinator of this site? Confirm its status | Cincinnati | United States | Recruiting |
| Louis Stokes VA Medical Center, Cleveland, OH Coordinator of this site? Confirm its status | Cleveland | United States | Not yet recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.