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Device
Auto-EPAP for Airway Blockage (Vivo NOVA Trial)
N/A
Waitlist Available
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
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 belowSelect...
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:Select...
I do not use my non-invasive ventilation device for at least 4 hours each night.
Select...
I use oxygen therapy at 5 liters per minute or more.
Select...
I do not understand English.
Select...
I have a medical opening into my windpipe.
Select...
I was hospitalized due to a sudden worsening of my condition in the last 3 months.
Select...
NIV therapy is not suitable for me due to medical reasons.
Select...
I have severe lung issues, recent brain surgery, or a leak in my brain fluid.
Select...
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
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.
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
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Who is running the clinical trial?
Breas Medical, Inc.Lead Sponsor
VeranexUNKNOWN
3 Previous Clinical Trials
54 Total Patients Enrolled
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