NCT06560411Completed
Evaluation of Auto-EPAP for Management of Upper Airway Obstruction During Non-Invasive Ventilation
Evaluation of Automatic Expiratory Positive Airway Pressure (Auto-EPAP) for Management of Upper Airway Obstruction During Non-Invasive Ventilation With Vivo 45 LS
Source: ClinicalTrials.gov · Last updated 28 Jan 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 23 (actual)
- First submitted
- 8 Aug 2024
- Start date
- 3 Oct 2024
- Primary completion date
- 7 Aug 2025
- Lead sponsor
- Breas Medical, Inc.
- NCT number
- NCT06560411
What you commit to
- Study type: Interventional
- Participants enrolled: 23
- From 3 Oct 2024 to the primary completion date, 7 Aug 2025
- 4 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Subject is on oxygen therapy ≥ 5 L/min.
- 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.
Other illness
- 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.
Other
- Subject is not compliant on NIV (e.g., \< 4 hr./night).
- Subject is pregnant.
- 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 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.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (4)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Delta Waves Coordinator of this site? Confirm its status | Colorado Springs | United States | Unknown status |
| Bogan Sleep Consultants Coordinator of this site? Confirm its status | Columbia | United States | Unknown status |
| University of California San Diego Coordinator of this site? Confirm its status | San Diego | United States | Unknown status |
| Insomnia and Sleep Institute of Arizona, LLC Coordinator of this site? Confirm its status | Scottsdale | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.