Clinical trial NCT06560411: Evaluation of Auto-EPAP for Management of Upper Airway Obstruction During Non-Invasive Ventilation
Official title: Evaluation of Automatic Expiratory Positive Airway Pressure (Auto-EPAP) for Management of Upper Airway Obstruction During Non-Invasive Ventilation With Vivo 45 LS
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
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)
Lead sponsor: Breas Medical, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Veranex, Inc.
First posted: 2024-08-19
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: The study is a prospective, multicenter, single-blind, randomized, cross-over study design.
Primary purpose: TREATMENT

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 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.

Primary outcomes:
measure: Exploratory effectiveness endpoint is to evaluate the subject's mean Oxygen Desaturation Index (ODI4%) during each overnight polysomnography assessment.
timeFrame: Up to Five Weeks
measure: Exploratory effectiveness endpoint is to evaluate the log of the subject's mean Apnea Hypopnea Index (AHI) during each overnight polysomnography assessment.
timeFrame: Up to Five Weeks
measure: The primary safety endpoint is the occurrence of device-related serious adverse events (SADEs).
timeFrame: Up to Five Weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Scottsdale
country: United States
facility: Insomnia and Sleep Institute of Arizona, LLC
state: Arizona
city: San Diego
country: United States
facility: University of California San Diego
state: California
city: Colorado Springs
country: United States
facility: Delta Waves
state: Colorado
city: Columbia
country: United States
facility: Bogan Sleep Consultants
state: South Carolina
Study officials:
References: