NCT07404826 · VA Office of Research and Development
PEP Buddy in Pulmonary Rehabilitation
(PEPR)
What this study is about
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.
View original scientific description
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.
Interventions
DEVICE
PEP Buddy
This is a small, portable device worn about the neck with a lanyard, that can be used to control symptoms of breathlessness associated with chronic lung disease.
DEVICE
PEP Buddy Sham
A Device that appears the same as PEP Buddy but only provides the expiratory pressure of the standard-of-care pursed lip breathing
Primary outcome measures
San Diego Shortness of breath Questionnaire
Time frame: 12 Months
This is a standardized survey used to quantify the impact of daily respiratory symptoms on quality of life. This will be collected on enrollment and the investigators will compare the change between groups at Weeks 3, 6, 9, and 12 and at six-and twelve-months after enrollment.
Daily steps measured by wrist-wron accelerometer
Time frame: 12 Months
Using accelerometry, the investigators will show the changes in daily step counts between groups over the one year of time in the study.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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
Where
- Cincinnati, Ohio
- Cleveland, Ohio
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jul 24, 2026 · Source of record for eligibility and locations