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Evaluation of Auto-EPAP for Management of Upper Airway Obstruction During Non-Invasive Ventilation | Clinical Trials | Clareo Health

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Evaluation of Auto-EPAP for Management of Upper Airway Obstruction During Non-Invasive Ventilation

Evaluation of Automatic Expiratory Positive Airway Pressure (Auto-EPAP) for Management of Upper Airway Obstruction During Non-Invasive Ventilation With Vivo 45 LS

NCT06560411•Breas Medical, Inc.

View on ClinicalTrials.gov

Summary

To evaluate the safety and effectiveness of the Automatic Expiratory Positive Airway Pressure (Auto-EPAP) feature versus manual expiratory positive airway pressure (EPAP) in the Vivo 45 LS Ventilator.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Subject has the ability to provide written informed consent.
•2. Subject is ≥ 18 years old.
•3. Subject has documented respiratory failure (e.g. sleep hypoventilation with historical transcutaneous carbon dioxide (PtCO2) increase ≥ 10mmHg) and/or daytime hypercapnia (\>45 mmHg).
•4. Subject is currently using non-invasive positive pressure ventilation (NIV) for 1 month.
•5. Subject has a previously documented apnea-hypopnea index (AHI) ≥ 5/hr.
•6. Subject's expiratory positive airway pressure (EPAP) settings were recently (≤ 12 months) reviewed.

Exclusion Criteria

•1. Subject is not compliant on NIV (e.g., \< 4 hr./night).
•2. Subject is pregnant.
•3. Subject is on oxygen therapy ≥ 5 L/min.
•4. Subject has an invasive interface (e.g. tracheostomy).
•5. Subject has had an acute exacerbation within the last 3 months that resulted in a hospitalization.
•6. Subject is acutely ill, medically complicated, or who are medically unstable.
•7. Subject in whom NIV therapy is otherwise medically contraindicated.
•8. Subject has had surgery of the upper airway, nose, sinus, or middle ear within the previous 90 days.
•9. Subjects with untreated, non-obstructive sleep apnea (OSA) sleep disorders, including but not limited to: insomnia, periodic limb movement syndrome, or restless leg syndrome.
•10. Subjects who have the following pre-existing conditions: severe bullous lung disease, recurrent pneumothorax or pneumomediastinum, cerebrospinal fluid leak, or recent cranial surgery or trauma.
+4 more criteria

Locations (4)

Insomnia and Sleep Institute of Arizona, LLC

Scottsdale, Arizona, United States

University of California San Diego

San Diego, California, United States

Delta Waves

Colorado Springs, Colorado, United States

Bogan Sleep Consultants

Columbia, South Carolina, United States

Key Dates

Start Date

October 3, 2024

Primary Completion Date

August 7, 2025

Completion Date

August 7, 2025

Last Updated

January 28, 2026

Enrollment

ACTUAL participants

Conditions

Obstructive Sleep ApneaObesity Hypoventilation Syndrome (OHS)Chronic Obstructive Pulmonary Disease (COPD)Neuromuscular Diseases (NMD)

Interventions

Non-Invasive Ventilation

DEVICE

OSA Risk Level in Dental Patients and Correlation With Complications After General Anesthesia

NCT06430957

Obstructive Sleep Apnea Risk ManagementPostoperative Complications+2 more

View study

RECRUITINGPHASE1/PHASE2

cfMSC Stem Cell Therapy Targeting COPD

NCT07477600

Chronic Obstructive Pulmonary Disease (COPD)

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 28, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Evaluation of Auto-EPAP for Management of Upper Airway Obstruction During Non-Invasive Ventilation

Inclusion Criteria

Exclusion Criteria

OSA Risk Level in Dental Patients and Correlation With Complications After General Anesthesia

cfMSC Stem Cell Therapy Targeting COPD

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Diaphragm Ultrasound İn Children With OSAS