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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-10-03

Study Completion Date

2025-06-30

Brief Summary

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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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Detailed Description

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Conditions

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Obstructive Sleep Apnea Obesity Hypoventilation Syndrome (OHS) Chronic Obstructive Pulmonary Disease (COPD) Neuromuscular Diseases (NMD)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

The study is a prospective, multicenter, single-blind, randomized, cross-over study design.

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study subjects will be blinded to the sequence arm that they are randomized to. Investigators and site study staff will be unblinded. The scorer(s) of the polysomnography will be blinded to which therapy is being used for objective determination of the primary endpoint.

Study Groups

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Auto Night One, Manual Night Two

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

Group Type ACTIVE_COMPARATOR

Non-Invasive Ventilation

Intervention Type DEVICE

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

Manual Night One, Auto Night Two

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 Type ACTIVE_COMPARATOR

Non-Invasive Ventilation

Intervention Type DEVICE

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

Interventions

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Non-Invasive Ventilation

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

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

1. Subject is not compliant on NIV (e.g., \< 4 hr./night).
2. Subject is pregnant.
3. Subject is on oxygen therapy ≥ 5 L/min.
4. Subject has an invasive interface (e.g. tracheostomy).
5. Subject has had an acute exacerbation within the last 3 months that resulted in a hospitalization.
6. Subject is acutely ill, medically complicated, or who are medically unstable.
7. Subject in whom NIV therapy is otherwise medically contraindicated.
8. Subject has had surgery of the upper airway, nose, sinus, or middle ear within the previous 90 days.
9. Subjects with untreated, non-obstructive sleep apnea (OSA) sleep disorders, including but not limited to: insomnia, periodic limb movement syndrome, or restless leg syndrome.
10. 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.
11. Subject does not comprehend English.
12. Subject is unable or unwilling to provide written informed consent.
13. Subject is physically and/or mentally unable to comply with the protocol.
14. Subject is not suitable to participate in the trial for any other reason in the opinion of the investigator.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No