PEP Buddy in Pulmonary Rehabilitation

Part of paid clinical trials in Cincinnati, Ohio.

Sponsor
VA Office of Research and Development
Study ID
NCT07404826
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
40 Years - 89 Years
Healthy Volunteers
Not accepted

Interventions

  • PEP Buddy — DEVICE
    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 — DEVICE
    A Device that appears the same as PEP Buddy but only provides the expiratory pressure of the standard-of-care pursed lip breathing

Study Details

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.

Key Dates

Start date
Apr 1, 2026
Status verified
Feb 2026
Primary completion
Mar 29, 2030
Completion
Mar 29, 2030

Study Design

Enrollment
120 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

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

Primary Outcome Measure

San Diego Shortness of breath Questionnaire [ Time Frame: 12 Months ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Cincinnati VA Medical Center, Cincinnati, OHCincinnatiOhio45220-2213
Robert M Burkes, MD MS
[email protected]
(724) 730-3862
Robert Matthew Burkes, MD MS (PRINCIPAL_INVESTIGATOR)
Louis Stokes VA Medical Center, Cleveland, OHClevelandOhio44106-1702
Frank Jacono, MD
[email protected]
216-791-3800
Anthony Vergis, MD
[email protected]
2167913800

Find similar trials in Cincinnati, OH

By condition
COPD
By specialty
PulmonologyLung disease
By research site
Cincinnati VA Medical Center, Cincinnati, OH· Cincinnati, OHLouis Stokes VA Medical Center, Cleveland, OH· Cleveland, OH

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