Portable Positive Pressure Therapy Device

Sponsor
Koronis Biomedical Technologies
Study ID
NCT04452851
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
21 Years - 85 Years
Healthy Volunteers
Not accepted

Interventions

  • BREATHE — DEVICE
    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 — DEVICE
    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 — DRUG
    Inhaler medication to support quick relief from COPD symptoms

Study Details

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.

Key Dates

First listed
Jul 1, 2020
Start date
Dec 1, 2026
Status verified
Mar 2025
Primary completion
Aug 1, 2027
Completion
Aug 1, 2027

Study Design

Enrollment
20 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
SUPPORTIVE_CARE

Arms

  • Experimental: Treadmill test with BREATHE
    Subjects will perform exercise tests identical to the treadmill tests from the baseline test. However, in this test, after they reach a Borg score of 7, they will be allowed to recover with the prototype BREATHE system until they are fully recovered (Borg: 0).
  • Active Comparator: Treadmill test with BiPAP
    Subjects will perform exercise tests identical to the treadmill tests from the baseline test. However, in this test, after they reach a Borg score of 7, they will be allowed to recover with a standard BiPAP machine until they are fully recovered (Borg: 0).
  • Placebo Comparator: Treadmill test with placebo inhaler
    Subjects will perform exercise tests identical to the treadmill tests from the baseline test. However, in this test, after they reach a Borg score of 7, they will be allowed to recover with a placebo inhaler until they are fully recovered (Borg: 0).
  • Experimental: Activity of Daily Living with BREATHE
    Subjects will be asked to complete Glittre-ADL tests with the BREATHE system being available for use throughout the test and recovery period. Borg scores will be measured after each minute of exercise and every 30 seconds during seated recovery until the subject is fully recovered (Borg: 0).
  • Experimental: Activity of Daily Living with BREATHE during recovery
    Subjects will be asked to complete Glittre-ADL tests with the BREATHE system being available for use throughout the test and recovery period. Borg scores will be measured after each minute of exercise and every 30 seconds during seated recovery until the subject is fully recovered (Borg: 0).
  • No Intervention: Activity of Daily Living
    Subjects will be asked to complete Glittre-ADL tests with the BREATHE system will NOT be available for use throughout the test and recovery period. Borg scores will be measured after each minute of exercise and every 30 seconds during seated recovery until the subject is fully recovered (Borg: 0).

Primary Outcome Measure

Recovery Time [ Time Frame: 30 minutes ]

Central Contacts

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