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

Breas Medical, Inc.

Status: Active, not recruiting

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

Treatments: Device: Non-Invasive Ventilation

Study type: Interventional

Funder types: Industry; Other

Identifiers

NCT06560411

BMCI-002

Details and patient eligibility

About

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.

Enrollment: 20 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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 ≥ 3 months.
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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

---

20 participants in 2 patient groups

Auto Night One, Manual Night Two

Active Comparator group

Description:

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

Treatment:

Device: Non-Invasive Ventilation

Manual Night One, Auto Night Two

Active Comparator group

Description:

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

Treatment:

Device: Non-Invasive Ventilation