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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores the effectiveness of the Automatic Expiratory Positive Airway Pressure (Auto-EPAP) feature compared to the manual version in a specific ventilator. The focus is on individuals with breathing issues, such as sleep-related breathing problems or elevated daytime carbon dioxide levels. Participants will use both Auto-EPAP and manual EPAP on different nights to determine which is more effective. This trial suits adults who have used non-invasive ventilation (a mask that aids breathing) for at least a month and have a known history of sleep-related breathing interruptions. As an unphased trial, it offers participants the chance to contribute to valuable research that could enhance future treatments for breathing issues.

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 prior data suggests that the Auto-EPAP feature is safe for airway blockage?

Research has shown that EPAP devices, such as Auto-EPAP, generally provide a safe way to help with blocked airways. Studies indicate that most people find EPAP therapy, including automatic versions, easy to use. For instance, one study found that using an EPAP mask was safe and effective for individuals with certain sleep disorders. Another study showed that both adults and children can use these devices safely.

Although these devices are generally safe, some people might need time to adjust to wearing them. Overall, Auto-EPAP is considered a safe choice for those needing help with airway issues. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Auto-EPAP trial because it's exploring a new way to address airway blockages using automatic adjustments. Traditional treatments often rely on manual settings for devices like CPAP machines, which can be less responsive to a patient's changing needs during sleep. Auto-EPAP stands out by automatically adjusting the expiratory pressure in real-time, potentially offering a more personalized and effective experience. This dynamic approach could improve comfort and effectiveness, helping patients breathe easier throughout the night.

What evidence suggests that the Auto-EPAP feature is effective for airway blockage?

Research shows that Auto-EPAP can effectively reduce airway blockages. One study found that using a device with Auto-EPAP significantly decreased sleep disruptions, as measured by the apnea-hypopnea index (AHI), from 15.7 to 4.7 events per hour. This reduction means fewer breathing interruptions during sleep. In this trial, participants will experience both Auto-EPAP and Manual EPAP settings on different nights. Other studies indicate that people using automatic airway pressure often sleep more restfully and with better quality than with manual settings. Participants reported feeling more comfortable and having less difficulty falling asleep. Overall, Auto-EPAP shows promise in improving sleep quality and reducing breathing problems. ^{4 6 7 8 9}

Are You a Good Fit for This Trial?

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 has the ability to provide written informed consent

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

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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]

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]

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]

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]

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]

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 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]

Citations

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Auto-EPAP for Airway Blockage (Vivo NOVA Trial)

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pmc.ncbi.nlm.nih.gov

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Auto-CPAP is effective in treatment of Vietnamese patients with severe OSA in short term follow up.

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atsjournals.org

atsjournals.org/doi/10.1164/rccm.200201-022OC

Comparison between Automatic and Fixed Positive Airway ...

During automatic therapy, patients reported more restful sleep, better quality sleep, less discomfort from pressure, and less trouble getting to sleep.

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pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC3190843/

Long-Term Use of a Nasal Expiratory Positive Airway ...

Nasal EPAP significantly reduced the AHI, improved subjective daytime sleepiness and reduced snoring after 12 months of treatment.

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sciencedirect.com

sciencedirect.com/science/article/abs/pii/S0385814618300592

Efficacy and safety assessment of expiratory positive ...

Conclusions. EPAP mask therapy was safe and reliable with significant efficacy for selected OSAHS patients. However, the compliance needs further improvement.

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Treatment of Adult Obstructive Sleep Apnea With Positive ...

The data demonstrated that PAP compared to no treatment results in a clinically significant reduction in disease severity, sleepiness, blood pressure, and motor ...