Portable Positive Pressure Therapy Device

NCT04452851 | Not Yet Recruiting DMC FDA Device

• 1 other identifier: R44HL154932
• Study Type: interventional
• Target: 20
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

COPD

Outcome Measures

Primary Outcomes (1)

• Recovery Time

  The time it takes to return to 0 on the Borg Dyspnoea Scale ("No difficulty breathing") following exercise. This is a scale that asks you to rate the difficulty of your breathing. It starts at number 0 where your breathing is causing you no difficulty at all and progresses through to number 10 where your breathing difficulty is maximal.

  30 minutes

Study Arms (6)

Treadmill test with BREATHE

EXPERIMENTAL

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).

Device: BREATHE

Treadmill test with BiPAP

ACTIVE COMPARATOR

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).

Device: BiPAP

Treadmill test with placebo inhaler

PLACEBO COMPARATOR

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).

Drug: COPD Inhaler

Activity of Daily Living with BREATHE

EXPERIMENTAL

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).

Device: BREATHE

Activity of Daily Living with BREATHE during recovery

EXPERIMENTAL

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).

Device: BREATHE

Activity of Daily Living

NO INTERVENTION

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).

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.

Activity of Daily Living with BREATHE; Activity of Daily Living with BREATHE during recovery; Treadmill test with BREATHE

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.

Treadmill test with BiPAP

COPD Inhaler DRUG

Inhaler medication to support quick relief from COPD symptoms

Treadmill test with placebo inhaler

Eligibility Criteria

• Age: 21 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subject is age 21 to 85
• Clinically stable
• Diagnosis of COPD following ERS-ATS guidelines 2011 update with GOLD criteria stage 3 ("Severe"), 30% ≤ FEV1 \< 50%
• Capable of giving informed consent
• Willing and able to comply with the test program as directed by staff.

You may not qualify if:

• Subject is not fluent in written or spoken English
• Has physical impairment that prevents the subject from being able to walk or stand
• Is acutely ill/medically complicated, as determined by the investigator.

Sponsors & Collaborators

• Koronis Biomedical Technologies: lead

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Robert Knuesel, PhD

  Koronis Biomedical Technologies

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Patrick Lichter

CONTACT

6127301091; plichter@koronisbiotech.com

Robert Knuesel, PhD

CONTACT

(507) 459-8625; rknuesel@koronisbiotech.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Subjects will be asked to participate in four (4) visits. During the first visit, baseline measurements will be made. In the subsequent three (3) sessions, subjects will be asked to perform two (2) tests from a group of six (6) options. This list of tests is comprised of three BiPAP Equivalency tests and three Activity of Daily Living Simulations. Participants will be randomized to study groups using a table of random numbers generated at the outset of the study to determine the test order.

Study Record Dates

• First Submitted: June 24, 2020
• First Posted: July 1, 2020
• Study Start (Estimated): December 1, 2026
• Primary Completion (Estimated): August 1, 2027
• Study Completion (Estimated): August 1, 2027
• Last Updated: March 25, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share