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PEP Buddy in Pulmonary Rehabilitation

NCT07404826 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2026-02-17

No results posted yet for this study

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.

Conditions

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

Sponsors & Collaborators

  • VA Office of Research and Development

    lead FED

Principal Investigators

  • Robert Matthew Burkes, MD MS · Cincinnati VA Medical Center, Cincinnati, OH

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Max Age
89 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-04-01
Primary Completion
2030-03-29
Completion
2030-03-29
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07404826 on ClinicalTrials.gov