Evaluating a new breathing support method for patients with airway obstruction

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

This study is testing a new breathing support method called Auto-EPAP to see if it helps adults with breathing problems feel better when using a ventilator.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 20 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Breas Medical, Inc. (Industry-sponsored)
• Locations: 4 sites (Scottsdale, Arizona and 3 other locations)
• Trial ID: NCT06560411 on ClinicalTrials.gov

What this trial studies

This study evaluates the safety and effectiveness of the Automatic Expiratory Positive Airway Pressure (Auto-EPAP) feature compared to manual EPAP in patients using non-invasive ventilation. Participants will include adults with documented respiratory failure and a history of obstructive sleep apnea or related conditions. The study aims to determine if Auto-EPAP can improve patient outcomes in managing upper airway obstruction during ventilation. The intervention involves the use of the Vivo 45 LS Ventilator over a specified period.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older who have documented respiratory failure and are currently using non-invasive positive pressure ventilation.

Not a fit: Patients who are non-compliant with non-invasive ventilation or have acute medical conditions may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved management of respiratory failure in patients with obstructive sleep apnea and related conditions.

How similar studies have performed: Other studies have shown promise in using similar non-invasive ventilation approaches, suggesting potential for success in this evaluation.

Eligibility criteria

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.

Where this trial is running

Scottsdale, Arizona and 3 other locations

• Insomnia and Sleep Institute of Arizona, LLC — Scottsdale, Arizona, United States (Recruiting)
• University of California San Diego — San Diego, California, United States (Recruiting)
• Delta Waves — Colorado Springs, Colorado, United States (Recruiting)
• Bogan Sleep Consultants — Columbia, South Carolina, United States (Recruiting)

Conditions Obstructive Sleep Apnea; Obesity Hypoventilation Syndrome; Chronic Obstructive Pulmonary Disease; Neuromuscular Diseases; Sleep Apnea; Non-Invasive Ventilation; Respiratory Failure; Polysomnography