Status:
RECRUITING
Evaluation of Auto-EPAP for Management of Upper Airway Obstruction During Non-Invasive Ventilation
Lead Sponsor:
Breas Medical, Inc.
Collaborating Sponsors:
Veranex, Inc.
Conditions:
Obstructive Sleep Apnea
Obesity Hypoventilation Syndrome (OHS)
Eligibility:
All Genders
18+ years
Phase:
NA
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.
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
October 3 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2025
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT06560411
Start Date
October 3 2024
End Date
June 1 2025
Last Update
April 13 2025
Active Locations (4)
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1
Insomnia and Sleep Institute of Arizona, LLC
Scottsdale, Arizona, United States, 85255
2
University of California San Diego
San Diego, California, United States, 92121
3
Delta Waves
Colorado Springs, Colorado, United States, 80918
4
Bogan Sleep Consultants
Columbia, South Carolina, United States, 29201