Obstructive Sleep ApneaVivo NOVANCT06560411
Evaluation of Auto-EPAP for Management of Upper Airway Obstruction During Non-Invasive Ventilation
A study testing Non-Invasive Ventilation in people with Obstructive Sleep Apnea and Obesity Hypoventilation Syndrome (OHS), run by Breas Medical, Inc. at 4 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Obstructive Sleep Apnea, Obesity Hypoventilation Syndrome (OHS), Chronic Obstructive Pulmonary Disease (COPD)
- What is being tested?
- Non-Invasive Ventilation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 4 sitesUnited States
- Study dates
- 3 Oct 2024to 7 Aug 2025
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Delta Waves
Colorado Springs, Colorado, 80918
Bogan Sleep Consultants
Columbia, South Carolina, 29201
University of California San Diego
San Diego, California, 92121
Insomnia and Sleep Institute of Arizona, LLC
Scottsdale, Arizona, 85255
About this study
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
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)
- Being tested
- Non-Invasive Ventilation
- Keywords
- Sleep Apnea, Non-Invasive Ventilation (NIV), Respiratory Failure, Polysomnography, Apnea-Hypopnea Index (AHI), Expiratory Positive Airway Pressure (EPAP)
- Medical subject headings
- Sleep Apnea, Obstructive, Obesity Hypoventilation Syndrome, Pulmonary Disease, Chronic Obstructive, Neuromuscular Diseases, Sleep Apnea Syndromes, Respiratory Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-Invasive VentilationDevice
Provide continuous or intermittent ventilatory support for the care of individuals who require mechanical ventilation
| Study group | Role | What they receive |
|---|---|---|
| Auto Night One, Manual Night Two | Active comparator | 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 Receives: Device: Non-Invasive Ventilation |
| Manual Night One, Auto Night Two | Active comparator | 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 Receives: Device: Non-Invasive Ventilation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Exploratory effectiveness endpoint is to evaluate the subject's mean Oxygen Desaturation Index (ODI4%) during each overnight polysomnography assessment.
The log of the subject's mean Oxygen Desaturation Index (ODI4%) measured during each overnight polysomnography assessment (i.e., log10 (mean+1)).
Measured: Up to Five Weeks
Exploratory effectiveness endpoint is to evaluate the log of the subject's mean Apnea Hypopnea Index (AHI) during each overnight polysomnography assessment.
The log of the subject's mean Apnea Hypopnea Index (AHI) measured during each overnight polysomnography assessment (i.e., log10 (mean+1)).
Measured: Up to Five Weeks
The primary safety endpoint is the occurrence of device-related serious adverse events (SADEs).
Measured: Up to Five Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2024
- Study start3 Oct 2024
- Primary completion7 Aug 2025
- Study completion7 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obstructive Sleep ApneaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- The study is a prospective, multicenter, single-blind, randomized, cross-over study design.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Breas Medical, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Veranex, Inc.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06560411
- Sponsor's protocol ID
- BMCI-002
- Acronym
- Vivo NOVA
- Status last verified
- Jan 2026
- First submitted
- 8 Aug 2024
- Last updated
- 28 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes