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

NCT06560411 | Completed FDA Device

• 1 other identifier: BMCI-002
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 4

Brief 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.

Conditions

Obstructive Sleep Apnea; Obesity Hypoventilation Syndrome (OHS); Chronic Obstructive Pulmonary Disease (COPD); Neuromuscular Diseases (NMD)

Keywords

Sleep Apnea; Non-Invasive Ventilation (NIV); Respiratory Failure; Polysomnography; Apnea-Hypopnea Index (AHI); Expiratory Positive Airway Pressure (EPAP)

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (2)

Auto Night One, Manual Night Two

ACTIVE COMPARATOR

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

Manual Night One, Auto Night Two

ACTIVE COMPARATOR

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

Interventions

Non-Invasive Ventilation DEVICE

Provide continuous or intermittent ventilatory support for the care of individuals who require mechanical ventilation

Auto Night One, Manual Night Two; Manual Night One, Auto Night Two

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

• Subject is not compliant on NIV (e.g., \< 4 hr./night).
• Subject is pregnant.
• Subject is on oxygen therapy ≥ 5 L/min.
• Subject has an invasive interface (e.g. tracheostomy).
• Subject has had an acute exacerbation within the last 3 months that resulted in a hospitalization.
• Subject is acutely ill, medically complicated, or who are medically unstable.
• Subject in whom NIV therapy is otherwise medically contraindicated.
• Subject has had surgery of the upper airway, nose, sinus, or middle ear within the previous 90 days.
• Subjects with untreated, non-obstructive sleep apnea (OSA) sleep disorders, including but not limited to: insomnia, periodic limb movement syndrome, or restless leg syndrome.
• 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.
• Subject does not comprehend English.
• Subject is unable or unwilling to provide written informed consent.
• Subject is physically and/or mentally unable to comply with the protocol.
• Subject is not suitable to participate in the trial for any other reason in the opinion of the investigator.

Sponsors & Collaborators

• Breas Medical, Inc.: lead
• Veranex, Inc.: collaborator

Study Sites (4)

Insomnia and Sleep Institute of Arizona, LLC

Scottsdale, Arizona, 85255, United States

Location

University of California San Diego

San Diego, California, 92121, United States

Location

Delta Waves

Colorado Springs, Colorado, 80918, United States

Location

Bogan Sleep Consultants

Columbia, South Carolina, 29201, United States

Location

MeSH Terms

Conditions

Sleep Apnea, Obstructive; Obesity Hypoventilation Syndrome; Pulmonary Disease, Chronic Obstructive; Neuromuscular Diseases; Sleep Apnea Syndromes; Respiratory Insufficiency

Interventions

Noninvasive Ventilation

Condition Hierarchy (Ancestors)

Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Hypoventilation; Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Lung Diseases, Obstructive; Lung Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Respiration, Artificial; Airway Management; Therapeutics; Respiratory Therapy

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Study subjects will be blinded to the sequence arm that they are randomized to. Investigators and site study staff will be unblinded. The scorer(s) of the polysomnography will be blinded to which therapy is being used for objective determination of the primary endpoint.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: The study is a prospective, multicenter, single-blind, randomized, cross-over study design.

Study Record Dates

• First Submitted: August 8, 2024
• First Posted: August 19, 2024
• Study Start: October 3, 2024
• Primary Completion: August 7, 2025
• Study Completion: August 7, 2025
• Last Updated: January 28, 2026

Record last verified: 2026-01

Locations

US (4)