Auto-EPAP for Airway Blockage

(Vivo NOVA Trial)

Recruiting at 3 trial locations

Overseen By Richard Bogan, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Trial Phase: Academic

Sponsor: Breas Medical, Inc.

Disqualifiers: Pregnancy, Oxygen therapy, Invasive interface, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

Duration: 2 nights

20 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the treatment Auto-EPAP for airway blockage?

Research shows that expiratory positive airway pressure (EPAP) devices are effective in treating obstructive sleep apnea (OSA) by maintaining open airways during sleep. Additionally, EPAP has been beneficial in managing respiratory conditions like acute respiratory failure and improving breathing in patients with auto-PEEP, suggesting potential effectiveness for airway blockage. ^{1 2 3 4 5}

Is Auto-EPAP safe for humans?

Research on expiratory positive airway pressure (EPAP) devices, which are similar to Auto-EPAP, shows they are generally safe for treating conditions like obstructive sleep apnea (OSA). Studies have evaluated the safety of EPAP devices in both adults and children, indicating they are a safe option for managing airway blockage. ^{1 3 5 6 7}

How is the Auto-EPAP treatment different from other treatments for airway blockage?

Auto-EPAP is unique because it automatically adjusts the pressure during exhalation to keep the airways open, which can help reduce breathing difficulties without the need for a ventilator. This is different from traditional treatments that may require mechanical ventilation or fixed pressure settings. ^{3 4 8 9 10}

Eligibility Criteria

This trial is for people with conditions like COPD, sleep apnea, obesity hypoventilation syndrome, neuromuscular diseases such as muscular dystrophy, and other obstructive lung issues. Specific eligibility criteria are not provided.

Inclusion Criteria

Subject is currently using non-invasive positive pressure ventilation (NIV) for ≥ 3 months

Subject has the ability to provide written informed consent

Subject has a previously documented apnea-hypopnea index (AHI) ≥ 5/hr

Exclusion Criteria

Subject is not currently using NIV therapy (BiPAP, ASV, etc.)

NIV therapy is not suitable for me due to medical reasons.

I was hospitalized due to a sudden worsening of my condition in the last 3 months.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants undergo Manual and Automatic Expiratory Positive Airway Pressure (EPAP) during Non-Invasive Ventilation in polysomnography (PSG) over two nights

2 nights

2 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, focusing on Oxygen Desaturation Index (ODI4%) and Apnea Hypopnea Index (AHI)

Up to 5 weeks

Treatment Details

Interventions

• Auto-EPAP

Trial Overview The study is testing the safety and effectiveness of an Automatic Expiratory Positive Airway Pressure (Auto-EPAP) feature compared to manual EPAP on a Vivo 45 LS Ventilator in patients with upper airway obstruction.

Participant Groups

Group I: Manual Night One, Auto Night Two Active Control 1 Intervention

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

Group II: Auto Night One, Manual Night Two Active Control 1 Intervention

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

Who Is Running the Clinical Trial?

Breas Medical, Inc.

Lead Sponsor

Trials

1

Recruited

20+

Veranex

Collaborator

Trials

4

Recruited

80+

Veranex, Inc.

Collaborator

Trials

1

Recruited

130+

Findings from Research

The nasal expiratory positive airway pressure (EPAP) device significantly reduced the apnea-hypopnea index (AHI) from 15.7 to 4.7 events per hour after 12 months of treatment, indicating effective long-term management of obstructive sleep apnea (OSA).

Patients reported a 74.4% reduction in snoring and a significant decrease in daytime sleepiness, as measured by the Epworth Sleepiness Scale, demonstrating both efficacy and improved quality of life with excellent adherence to the device (89.3% of nights used).

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Long-term use of a nasal expiratory positive airway pressure (EPAP) device as a treatment for obstructive sleep apnea (OSA). Kryger, MH., Berry, RB., Massie, CA.[2021]

Early use of end-expiratory pressure (EPAP) can be beneficial for patients with acute respiratory failure, as it allows for treatment without the need for intubation.

Case studies of three patients with mild ARDS, aspiration pneumonia, and postoperative atelectasis demonstrate that EPAP can effectively manage respiratory issues while minimizing complications associated with high flow rates from CPAP.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

EPAP without intubation. Schmidt, GB., Parulkar, DS., Brennan, T., et al.[2020]

In a study of 10 patients with suspected auto-positive end-expiratory pressure (auto-PEEP), the electrical activity of the diaphragm (EAdi) was found to be a reliable indicator for estimating auto-PEEP levels during mechanical ventilation.

Using Neurally Adjusted Ventilatory Assist (NAVA) resulted in lower pressures needed to overcome auto-PEEP compared to traditional pressure support ventilation, suggesting that NAVA may be more effective in managing patients with auto-PEEP.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical assessment of auto-positive end-expiratory pressure by diaphragmatic electrical activity during pressure support and neurally adjusted ventilatory assist. Bellani, G., Coppadoro, A., Patroniti, N., et al.[2016]

Auto-PEEP is a common issue in patients with acute respiratory failure on mechanical ventilation, leading to significant respiratory and hemodynamic problems, and can be identified by measuring airflow at the end of exhalation.

Strategies to manage auto-PEEP include reducing minute ventilation and using low levels of external PEEP, which can alleviate symptoms and improve overall respiratory function without increasing hyperinflation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Auto-PEEP in respiratory failure. Laghi, F., Goyal, A.[2012]

The expiratory positive airway pressure (EPAP) mask therapy is safe and effective for treating selected patients with moderate to severe Obstructive Sleep Apnea Hypopnea Syndrome (OSAHS), showing similar efficacy to continuous positive airway pressure (CPAP) therapy.

In a study involving 40 OSAHS patients, both EPAP and CPAP therapies significantly improved sleep quality and oxygen levels, but patient compliance with the EPAP mask needs to be enhanced for better long-term use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy and safety assessment of expiratory positive airway pressure (EPAP) mask for OSAHS therapy. Liu, Y., Ying, Y., Pandu, JS., et al.[2019]

A study of 19 obese children aged 5-15 with obstructive sleep apnea showed that using autoCPAP significantly reduced their apnea-hypopnea index (AHI) from 12.3/h to 1.7/h after 30 days, indicating effective treatment.

No adverse outcomes were reported, suggesting that autoCPAP is a safe therapy for this group, and it may help reduce delays in treatment for children with obesity and obstructive sleep apnea.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Use of Auto-Titrating Continuous Positive Airway Pressure (AutoCPAP) for Obstructive Sleep Apnea Syndrome in Children with Obesity. Benke, S., Okorie, CUA., Tablizo, MA.[2021]

The ULTepap device generates expiratory pressures comparable to the Provent device across various flow rates, making it a competitive option for treating obstructive sleep apnea (OSA).

In contrast, Bongo Rx and Theravent devices produced significantly lower backpressures, indicating that not all FDA-cleared EPAP devices are equally effective, highlighting the need for clinical trials to assess their efficacy and patient adherence.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of expiratory pressures generated by four different EPAP devices in a laboratory bench setting. Sleeper, G., Rashidi, M., Strohl, KP., et al.[2022]

EPAP nasal devices are a promising treatment for obstructive sleep apnea (OSA), showing a reduction in the apnea/hypopnea index (AHI) and daytime sleepiness, with patients generally preferring them over CPAP.

While CPAP is more effective for improving sleep apnea, EPAP can provide similar symptom relief for patients with mild to moderate OSA who cannot tolerate CPAP, although more well-designed clinical trials are needed to fully assess its efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A review of EPAP nasal device therapy for obstructive sleep apnea syndrome. Wu, H., Yuan, X., Zhan, X., et al.[2021]

In a study of four patients with severe asthma on mechanical ventilation, low measured auto-end-expiratory pressure (auto-PEEP) was observed despite significant increases in peak and plateau airway pressures, indicating that auto-PEEP may not accurately reflect alveolar pressure in these cases.

The findings suggest that prolonged expiratory time can lead to a notable decrease in measured auto-PEEP, highlighting that pulmonary hyperinflation can still occur even when auto-PEEP readings are low, particularly at lower respiratory rates.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Low measured auto-positive end-expiratory pressure during mechanical ventilation of patients with severe asthma: hidden auto-positive end-expiratory pressure. Leatherman, JW., Ravenscraft, SA.[2019]

Auto-positive end-expiratory pressure (auto-PEEP) is a frequent issue in patients on ventilatory support, which can lead to significant complications if not addressed.

It is crucial for healthcare providers to recognize and manage auto-PEEP to ensure safer weaning from mechanical ventilation and improve patient outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Auto-positive end-expiratory pressure: mechanisms and treatment. Mughal, MM., Culver, DA., Minai, OA., et al.[2022]

References

1. United States pubmed.ncbi.nlm.nih.gov

Long-term use of a nasal expiratory positive airway pressure (EPAP) device as a treatment for obstructive sleep apnea (OSA). [2021]

2. United States pubmed.ncbi.nlm.nih.gov

EPAP without intubation. [2020]

3. United States pubmed.ncbi.nlm.nih.gov

Clinical assessment of auto-positive end-expiratory pressure by diaphragmatic electrical activity during pressure support and neurally adjusted ventilatory assist. [2016]

4. Italy pubmed.ncbi.nlm.nih.gov

Auto-PEEP in respiratory failure. [2012]

5. Netherlands pubmed.ncbi.nlm.nih.gov

Efficacy and safety assessment of expiratory positive airway pressure (EPAP) mask for OSAHS therapy. [2019]

6. Switzerland pubmed.ncbi.nlm.nih.gov

The Use of Auto-Titrating Continuous Positive Airway Pressure (AutoCPAP) for Obstructive Sleep Apnea Syndrome in Children with Obesity. [2021]

7. Netherlands pubmed.ncbi.nlm.nih.gov

Comparison of expiratory pressures generated by four different EPAP devices in a laboratory bench setting. [2022]

8. Germany pubmed.ncbi.nlm.nih.gov

A review of EPAP nasal device therapy for obstructive sleep apnea syndrome. [2021]

9. United States pubmed.ncbi.nlm.nih.gov

Low measured auto-positive end-expiratory pressure during mechanical ventilation of patients with severe asthma: hidden auto-positive end-expiratory pressure. [2019]

10. United States pubmed.ncbi.nlm.nih.gov

Auto-positive end-expiratory pressure: mechanisms and treatment. [2022]