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

Description

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)

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Study Details

Study overview

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.

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

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

Condition
Obstructive Sleep Apnea
Intervention / Treatment

-

Contacts and Locations

Scottsdale

Insomnia and Sleep Institute of Arizona, LLC, Scottsdale, Arizona, United States, 85255

Colorado Springs

Delta Waves, Colorado Springs, Colorado, United States, 80918

Columbia

Bogan Sleep Consultants, Columbia, South Carolina, United States, 29201

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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.
  • 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.

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Breas Medical, Inc.,

Study Record Dates

2024-12