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Portable Positive Pressure Therapy Device
Sponsor: Koronis Biomedical Technologies
Summary
This study will assess the impact the BREATHE device provides on post-exertion recovery time in COPD patients when used during and/or after performing an Activity of Daily Living simulation. It will also establish equivalency with BiPAP machines.
Official title: Portable Non-invasive Positive Pressure Airway Device Therapy System Efficacy Study
Key Details
Gender
All
Age Range
21 Years - 85 Years
Study Type
INTERVENTIONAL
Enrollment
20
Start Date
2026-12-01
Completion Date
2027-08-01
Last Updated
2025-03-25
Healthy Volunteers
No
Conditions
Interventions
BREATHE
The on-demand handheld portable noninvasive positive pressure airway device unit generates BiPAP by using a built-in blower which intakes air from the nearby ambient. The BiPAP pressure functions as a virtual stent within the lungs of a user with COPD. The virtual stent opens the passageways within the user lungs. Once opened, the virtual stent facilitates gas exchange in order to relieve dyspnea. By temporarily facilitating this gas exchange, the user will quickly recover from dyspnea in order to resume regular activities.
BiPAP
BiPAP stands for Bilevel Positive Airway Pressure, and is very similar in function and design to a CPAP machine (continuous positive airway pressure). A BiPAP machine is a non-invasive form of therapy for patients suffering from sleep apnea.
COPD Inhaler
Inhaler medication to support quick relief from COPD symptoms