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NOT YET RECRUITING
NCT04452851
NA

Portable Positive Pressure Therapy Device

Sponsor: Koronis Biomedical Technologies

View on ClinicalTrials.gov

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

DEVICE

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.

DEVICE

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.

DRUG

COPD Inhaler

Inhaler medication to support quick relief from COPD symptoms