Recruiting

Breathing Device

Sponsor:

VA Office of Research and Development

Code:

NCT07404826

Conditions

COPD

Eligibility Criteria

Sex: All

Age: 40 - 70+

Healthy Volunteers: Not accepted

Interventions

PEP Buddy

PEP Buddy Sham

Study Details

Brief 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

COPD

Study ID

NCT07404826

Start date

Jul 16, 2026

Status verified date

Jul, 2026

Completion date

Jul 29, 2030

Anticipated

Primary completion date

Jul 29, 2030

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 40 - 70+

Healthy Volunteers: Not 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

Study Design

Enrollment

120 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: PEP Buddy

This arm will be provided with a portable device that provides 5-7 cm H2O of expiratory pressure, to be used when subjectively breathless

sham comparator: Sham

This arm will be provided with a portable device that appears the same as PEP Buddy but provides 1-3 cm H2O of expiratory pressure, to be used when subjectively breathless

Interventions

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.

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 measure

  • San Diego Shortness of breath Questionnaire [ Time Frame: 12 Months ]
  • Daily steps measured by wrist-wron accelerometer [ Time Frame: 12 Months ]

Central Contacts and Locations

Central contacts

Robert M Burkes, MD MS

(724) 730-3862robert.burkes@va.gov

Locations

Cincinnati VA Medical Center, Cincinnati, OH

Recruiting

Cincinnati, Ohio, United States, 45220-2213

Contacts

Robert M Burkes, MD MS

(724) 730-3862robert.burkes@va.gov

Principal Investigator:

Robert Matthew Burkes, MD MS

More Information

Sponsor

VA Office of Research and Development

Last update posted

Jul 24, 2026

Last verified

Jul, 2026

Keywords

  • Pulmonary Rehabilitation

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by VA Office of Research and Development on 2026-07-24.