Evaluation of Auto-EPAP for Management of Upper Airway Obstruction During Non-Invasive Ventilation (Vivo NOVA)

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

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.

Study Overview

• Status: Completed
• Conditions: Obstructive Sleep Apnea; Chronic Obstructive Pulmonary Disease (COPD); Obesity Hypoventilation Syndrome (OHS); Neuromuscular Diseases (NMD)
• Intervention / Treatment: Device: Non-Invasive Ventilation

• Study Type: Interventional
• Enrollment (Actual): 23
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Scottsdale, Arizona, United States, 85255
      • Insomnia and Sleep Institute of Arizona, LLC
  • California
    • San Diego, California, United States, 92121
      • University of California San Diego
  • Colorado
    • Colorado Springs, Colorado, United States, 80918
      • Delta Waves
  • South Carolina
    • Columbia, South Carolina, United States, 29201
      • Bogan Sleep Consultants

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.
11. Subject does not comprehend English.
12. Subject is unable or unwilling to provide written informed consent.
13. Subject is physically and/or mentally unable to comply with the protocol.
14. Subject is not suitable to participate in the trial for any other reason in the opinion of the investigator.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Auto Night One, Manual Night Two; Will undergo Automatic Expiratory Positive Airway Pressure (EPAP) during Non-Invasive Ventilation in polysomnography (PSG) Night 1; Will undergo Manual EPAP during Non-Invasive Ventilation in PSG Night 2	Device: Non-Invasive Ventilation; Provide continuous or intermittent ventilatory support for the care of individuals who require mechanical ventilation
Active Comparator: Manual Night One, Auto Night Two; Will undergo Manual Expiratory Positive Airway Pressure (EPAP) during Non-Invasive Ventilation in polysomnography (PSG) Night 1; Will undergo Auto-EPAP during Non-Invasive Ventilation in PSG Night 2	Device: Non-Invasive Ventilation; Provide continuous or intermittent ventilatory support for the care of individuals who require mechanical ventilation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Exploratory effectiveness endpoint is to evaluate the subject's mean Oxygen Desaturation Index (ODI4%) during each overnight polysomnography assessment.	The log of the subject's mean Oxygen Desaturation Index (ODI4%) measured during each overnight polysomnography assessment (i.e., log10 (mean+1)).	Up to Five Weeks
Exploratory effectiveness endpoint is to evaluate the log of the subject's mean Apnea Hypopnea Index (AHI) during each overnight polysomnography assessment.	The log of the subject's mean Apnea Hypopnea Index (AHI) measured during each overnight polysomnography assessment (i.e., log10 (mean+1)).	Up to Five Weeks
The primary safety endpoint is the occurrence of device-related serious adverse events (SADEs).		Up to Five Weeks

Collaborators and Investigators

• Sponsor: Breas Medical, Inc.
• Collaborators: Veranex, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): October 3, 2024
• Primary Completion (Actual): August 7, 2025
• Study Completion (Actual): August 7, 2025

Study Registration Dates

• First Submitted: August 8, 2024
• First Submitted That Met QC Criteria: August 15, 2024
• First Posted (Actual): August 19, 2024

Study Record Updates

• Last Update Posted (Actual): January 28, 2026
• Last Update Submitted That Met QC Criteria: January 27, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: Sleep Apnea; Polysomnography; Respiratory Failure; Apnea-Hypopnea Index (AHI); Non-Invasive Ventilation (NIV); Expiratory Positive Airway Pressure (EPAP)
• Additional Relevant MeSH Terms: Nervous System Diseases; Pathologic Processes; Nutrition Disorders; Chronic Disease; Disease Attributes; Overnutrition; Respiratory Tract Diseases; Lung Diseases; Respiration Disorders; Lung Diseases, Obstructive; Sleep Wake Disorders; Overweight; Apnea; Sleep Disorders, Intrinsic; Dyssomnias; Obesity; Pathological Conditions, Signs and Symptoms; Nutritional and Metabolic Diseases; Hypoventilation; Pulmonary Disease, Chronic Obstructive; Respiratory Insufficiency; Sleep Apnea Syndromes; Sleep Apnea, Obstructive; Neuromuscular Diseases; Obesity Hypoventilation Syndrome; Therapeutics; Airway Management; Respiratory Therapy; Respiration, Artificial; Noninvasive Ventilation
• Other Study ID Numbers: BMCI-002

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No