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OpenTrials
Completed

NCT Number: NCT06560411

Evaluation of Auto-EPAP for Management of Upper Airway Obstruction During Non-Invasive Ventilation

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.

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Key information

Conditions

Obstructive Sleep Apnea Apnea Chronic Disease Chronic Obstructive Pulmonary Disease (COPD) Disease Attributes Dyssomnias Hypoventilation Lung Diseases Lung Diseases, Obstructive Nervous System Diseases Neuromuscular Diseases Neuromuscular Diseases (NMD) Nutrition Disorders Nutritional and Metabolic Diseases Obesity Obesity Hypoventilation Syndrome Obesity Hypoventilation Syndrome (OHS) Overnutrition Overweight Pathologic Processes Pathological Conditions, Signs and Symptoms Pulmonary Disease, Chronic Obstructive Respiration Disorders Respiratory Insufficiency Respiratory Tract Diseases Sleep Apnea Syndromes Sleep Apnea, Obstructive Sleep Disorders, Intrinsic Sleep Wake Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Insomnia and Sleep Institute of Arizona, LLC, Scottsdale, Arizona, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Subject has the ability to provide written informed consent.
  • Subject is ≥ 18 years old.
  • Subject has documented respiratory failure (e.g. sleep hypoventilation with historical transcutaneous carbon dioxide (PtCO2) increase ≥ 10mmHg) and/or daytime hypercapnia (>45 mmHg).
  • Subject is currently using non-invasive positive pressure ventilation (NIV) for 1 month.
  • Subject has a previously documented apnea-hypopnea index (AHI) ≥ 5/hr.
  • Subject's expiratory positive airway pressure (EPAP) settings were recently (≤ 12 months) reviewed.

Exclusion criteria

  • Subject is not compliant on NIV (e.g., < 4 hr./night).
  • Subject is pregnant.
  • Subject is on oxygen therapy ≥ 5 L/min.
  • Subject has an invasive interface (e.g. tracheostomy).
  • Subject has had an acute exacerbation within the last 3 months that resulted in a hospitalization.
  • Subject is acutely ill, medically complicated, or who are medically unstable.
  • Subject in whom NIV therapy is otherwise medically contraindicated.
  • Subject has had surgery of the upper airway, nose, sinus, or middle ear within the previous 90 days.
  • Subjects with untreated, non-obstructive sleep apnea (OSA) sleep disorders, including but not limited to: insomnia, periodic limb movement syndrome, or restless leg syndrome.
  • Subjects who have the following pre-existing conditions: severe bullous lung disease, recurrent pneumothorax or pneumomediastinum, cerebrospinal fluid leak, or recent cranial surgery or trauma.
  • Subject does not comprehend English.
  • Subject is unable or unwilling to provide written informed consent.
  • Subject is physically and/or mentally unable to comply with the protocol.
  • Subject is not suitable to participate in the trial for any other reason in the opinion of the investigator.

Treatment and study plan

Non-invasive ventilation

Device

Provide continuous or intermittent ventilatory support for the care of individuals who require mechanical ventilation

Primary outcomes

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

    Time frame: Up to Five Weeks

    The log of the subject's mean Oxygen Desaturation Index (ODI4%) measured during each overnight polysomnography assessment (i.e., log10 (mean+1)).

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

    Time frame: Up to Five Weeks

    The log of the subject's mean Apnea Hypopnea Index (AHI) measured during each overnight polysomnography assessment (i.e., log10 (mean+1)).

  3. The primary safety endpoint is the occurrence of device-related serious adverse events (SADEs).

    Time frame: Up to Five Weeks

Sponsors and collaborators

Lead sponsor

Breas Medical, Inc.

Industry

Collaborators

  • Veranex, Inc.

Registry information

Official study title

Evaluation of Automatic Expiratory Positive Airway Pressure (Auto-EPAP) for Management of Upper Airway Obstruction During Non-Invasive Ventilation With Vivo 45 LS

Acronym: Vivo NOVA

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Aug 19, 2024
Registry last updated
Jan 28, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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