A Portable Dyspnea Relief Device for Episodic Breathlessness in COPD (PEP-buddy): Effect on Dyspnea Severity and Mechanism of Action

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

Chronic dyspnea is the most characteristic symptom of patients with Chronic Obstructive Pulmonary Disease (COPD), with intermittent increases during exercise and other events.Despite optimal standard therapy, episodic dyspnea is a common occurrence in COPD. Recently, the PEP buddy was developed which is an easy-to use, hands-free device that generates positive expiratory pressure (PEP). Although currently the available evidence is limited, it indicates that utilizing the PEP-buddy can result in enhancements in dyspnea during exertion, exertional desaturation and overall quality of life. More research is needed to evaluate the effectiveness of this device and the long term usability, as well as getting more insight in the mechanism of action. Therefore, the aim of our study is to explore the potential of this device for patients with COPD and episodic breathlessness.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 40
Healthy Volunteers: f
View:

• Age ≥40 years

• Read, understood and signed Informed Consent

• COPD Gold class II-IV/ B or E (FEV1\<60% of predicted, CAT ≥10 points)

⁃ 5\. Optimized standard therapy according to the study physician 6. Episodic breathlessness requiring intervention (i.e. taking rest during physical activities, as needed inhalation medication, breathing techniques, as needed opioids) at least three days per week

Locations
Other Locations
Netherlands
UMCG
RECRUITING
Groningen
Contact Information
Primary
Jorine Hartman, PhD
j.hartman@umcg.nl
+31503616161
Backup
Marlies van Dijk, MD PhD
m.van.dijk05@umcg.nl
+31503616161
Time Frame
Start Date: 2024-01-31
Estimated Completion Date: 2025-12-31
Participants
Target number of participants: 25
Treatments
Experimental: PEP-buddy
Patients will use the PEP-buddy as needed.
Sponsors
Leads: University Medical Center Groningen

This content was sourced from clinicaltrials.gov