Auto-EPAP for Airway Blockage

(Vivo NOVA Trial)

Recruiting in Palo Alto (17 mi)

+2 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Breas Medical, Inc.

Disqualifiers: Pregnancy, Oxygen therapy, Invasive interface, others

No Placebo Group

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

I do not use my non-invasive ventilation device for at least 4 hours each night.

I had surgery on my nose, sinus, or ear in the last 3 months.

Subject is pregnant

Trial 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 (Device)

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

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

Insomnia and Sleep Institute of Arizona, LLC Scottsdale, AZ

Delta Waves Colorado Springs, CO

Bogan Sleep Consultants Columbia, SC

Who Is Running the Clinical Trial?

Breas Medical, Inc. Lead Sponsor

Veranex Collaborator

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] Evaluate the long-term durability of treatment response and safety of a nasal expiratory positive airway pressure (EPAP) device used to treat obstructive sleep apnea (OSA).

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

EPAP without intubation. [2020] The early institution of end expiratory pressure has been demonstrated frequently to be beneficial in acute respiratory failure. EPAP without intubation allows early therapy while avoiding the complications associated with the high flow rates utilized with CPAP. Three patients are described, illustrating the administration of EPAP for mild ARDS, aspiration penumonia, and postoperative atelectasis.

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] Auto-positive end-expiratory pressure (auto-PEEP) may substantially increase the inspiratory effort during assisted mechanical ventilation. Purpose of this study was to assess whether the electrical activity of the diaphragm (EAdi) signal can be reliably used to estimate auto-PEEP in patients undergoing pressure support ventilation and neurally adjusted ventilatory assist (NAVA) and whether NAVA was beneficial in comparison with pressure support ventilation in patients affected by auto-PEEP.

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

Auto-PEEP in respiratory failure. [2012] Intrinsic positive end-expiratory pressure (auto-PEEP) is a common occurrence in patients with acute respiratory failure requiring mechanical ventilation. Auto-PEEP can cause severe respiratory and hemodynamic compromise. The presence of auto-PEEP should be suspected when airflow at end-exhalation is not zero. In patients receiving controlled mechanical ventilation, auto-PEEP can be estimated measuring the rise in airway pressure during an end-expiratory occlusion maneuver. In patients who trigger the ventilator or who are not connected to a ventilator, auto-PEEP can be estimated by simultaneous recordings of airflow and airway and esophageal pressure, respectively. The best technique to accurately measure auto-PEEP in patients who actively recruit their expiratory muscle remains controversial. Strategies that may reduce auto-PEEP include reduction of minute ventilation, use of small tidal volumes and prolongation of the time available for exhalation. In patients in whom auto-PEEP is caused by expiratory flow limitation, the application of low-levels of external PEEP can reduce dyspnea, reduce work of breathing, improve patient-ventilator interaction and cardiac function, all without worsening hyperinflation. Neurally adjusted ventilatory assist, a novel strategy of ventilatory assist, may improve patient-ventilator interaction in patients with auto-PEEP.

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

Efficacy and safety assessment of expiratory positive airway pressure (EPAP) mask for OSAHS therapy. [2019] We have designed the expiratory positive airway pressure (EPAP) mask to provide a new sort of therapeutic strategies for Obstructive Sleep Apnea Hypopnea Syndrome (OSAHS). And this study aims to assess the safety, efficacy and compliance of the EPAP therapy.

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] Positive airway pressure can be an effective and safe therapy for children with obstructive sleep apnea syndrome (OSAS). Few studies have assessed the safety and efficacy of autoCPAP in pediatric patients with obesity.

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

Comparison of expiratory pressures generated by four different EPAP devices in a laboratory bench setting. [2022] Expiratory positive airway pressure (EPAP) has been a treatment option for patients with obstructive sleep apnea (OSA). ULTepap is a new FDA-cleared EPAP device that seals the nares with a nasal pillow interface. Comparisons of expiratory pressures generated by ULTepap and other EPAP devices like Provent, Bongo Rx, and Theravent are not available. We aimed to compare the backpressures created by these devices in an in vitro laboratory bench setting.

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

A review of EPAP nasal device therapy for obstructive sleep apnea syndrome. [2021] Expiratory positive airway pressure (EPAP) nasal devices provide a new therapeutic option for obstructive sleep apnea (OSA).

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] To describe the occurrence of low measured auto-end-expiratory pressure (auto-PEEP) during mechanical ventilation of patients severe asthma.

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

Auto-positive end-expiratory pressure: mechanisms and treatment. [2022] Auto-positive end-expiratory pressure (auto-PEEP) is a common problem in patients receiving full or partial ventilatory support, as well as in those ready to be weaned from the ventilator. Physicians should be alert for it and take measures to reduce it, as it can have serious consequences.