PEP Buddy in Pulmonary Rehabilitation for COPD

This study is testing a device called PEP Buddy for Veterans with Chronic Obstructive Pulmonary Disease (COPD). PEP Buddy is a small, portable device worn around the neck that may help control shortness of breath. You would be randomly assigned to receive either the actual PEP Buddy or a "sham" device that looks the same but only provides the breathing support of standard pursed-lip breathing. Researchers want to see if PEP Buddy helps improve symptoms and exercise ability faster during and after pulmonary rehabilitation. To join, you need to be a Veteran with COPD, aged 40-89, able to exercise on 4 liters per minute of oxygen, and have an FEV1 (a measure of lung function) less than 80% of what's expected. The study aims to enroll 120 participants and will measure improvements in shortness of breath and daily steps over 12 months.

Study design
This is a randomized, double-blinded, sham-controlled study involving 120 participants. You would be randomly assigned to receive either the PEP Buddy device or a sham device, and neither you nor the study staff would know which one you received.
What's involved
You would participate in pulmonary rehabilitation and use the assigned device. Your shortness of breath and daily steps would be measured over 12 months.
Compensation
Not stated in the trial record.
Follow-up
Your shortness of breath and daily steps will be measured for 12 months.

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NCT07404826

PEP Buddy in Pulmonary Rehabilitation

Recruiting
NAAges 40–89InterventionalTreatment
VA Office of Research and Development
~120 participants
Updated 2026-07-24 on ClinicalTrials.gov
What's tested:PEP BuddyPEP Buddy Sham

At a glance

Recruiting sites
1 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
San Diego Shortness of breath Questionnaire
Measured over 12 Months
+1 more outcome measured
COPD
2 sites across 1 states
Ohio2
  • Robert Matthew Burkes, MD MS · PRINCIPAL_INVESTIGATOR · Cincinnati VA Medical Center, Cincinnati, OH

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Eligibility criteria

Inclusion

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

Exclusion

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
  • San Diego Shortness of breath Questionnaire12 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 accelerometer12 Months

    Using accelerometry, the investigators will show the changes in daily step counts between groups over the one year of time in the study.