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Device

Auto-EPAP for Airway Blockage (Vivo NOVA Trial)

N/A

Recruiting

Research Sponsored by Breas Medical, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Subject has documented respiratory failure (e.g. sleep hypoventilation with historical transcutaneous carbon dioxide (PtCO2) increase ≥ 10mmHg) and/or daytime hypercapnia (>45 mmHg)

Be older than 18 years old

Must not have

Subject is not compliant on NIV (e.g., < 4 hr./night)

Subject is on oxygen therapy ≥ 5 L/min

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to five weeks

Awards & highlights

No Placebo-Only Group

Summary

"This trial will compare the safety and effectiveness of a new automatic expiratory positive airway pressure feature with the manual expiratory positive airway pressure on a specific ventilator called Vivo 45 LS

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Potential side effects are not detailed but may include discomfort or difficulty adapting to changes in pressure settings when using non-invasive ventilation devices.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have breathing failure, shown by high CO2 levels in my blood.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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

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I use oxygen therapy at 5 liters per minute or more.

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I do not understand English.

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I have a medical opening into my windpipe.

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

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

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I have severe lung issues, recent brain surgery, or a leak in my brain fluid.

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I am unable to follow the study's requirements due to physical or mental reasons.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to five weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to five weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to five weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Exploratory effectiveness endpoint is to evaluate the log of the subject's mean Apnea Hypopnea Index (AHI) during each overnight polysomnography assessment.

Exploratory effectiveness endpoint is to evaluate the subject's mean Oxygen Desaturation Index (ODI4%) during each overnight polysomnography assessment.

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Active Control

Group I: Manual Night One, Auto Night TwoActive Control1 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 TwoActive Control1 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

0 / 9Eligibility criteria met