COMPLETED

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

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Conditions

Obstructive Sleep ApneaObesity Hypoventilation Syndrome (OHS)Chronic Obstructive Pulmonary Disease (COPD)Neuromuscular Diseases (NMD)Sleep ApneaNon-Invasive Ventilation (NIV)Respiratory FailurePolysomnographyApnea-Hypopnea Index (AHI)Expiratory Positive Airway Pressure (EPAP)

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2024-10-03
Study Completion:2025-08-07
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:COMPLETED

Study ID

NCT06560411

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Subject has the ability to provide written informed consent.
  2. 2. Subject is ≥ 18 years old.
  3. 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. 4. Subject is currently using non-invasive positive pressure ventilation (NIV) for 1 month.
  5. 5. Subject has a previously documented apnea-hypopnea index (AHI) ≥ 5/hr.
  6. 6. Subject's expiratory positive airway pressure (EPAP) settings were recently (≤ 12 months) reviewed.
  1. 1. Subject is not compliant on NIV (e.g., \< 4 hr./night).
  2. 2. Subject is pregnant.
  3. 3. Subject is on oxygen therapy ≥ 5 L/min.
  4. 4. Subject has an invasive interface (e.g. tracheostomy).
  5. 5. Subject has had an acute exacerbation within the last 3 months that resulted in a hospitalization.
  6. 6. Subject is acutely ill, medically complicated, or who are medically unstable.
  7. 7. Subject in whom NIV therapy is otherwise medically contraindicated.
  8. 8. Subject has had surgery of the upper airway, nose, sinus, or middle ear within the previous 90 days.
  9. 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. 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. 11. Subject does not comprehend English.
  12. 12. Subject is unable or unwilling to provide written informed consent.
  13. 13. Subject is physically and/or mentally unable to comply with the protocol.
  14. 14. Subject is not suitable to participate in the trial for any other reason in the opinion of the investigator.

Contacts and Locations

Study Locations (Sites)

Insomnia and Sleep Institute of Arizona, LLC
Scottsdale, Arizona, 85255
United States
University of California San Diego
San Diego, California, 92121
United States
Delta Waves
Colorado Springs, Colorado, 80918
United States
Bogan Sleep Consultants
Columbia, South Carolina, 29201
United States

Collaborators and Investigators

Sponsor: Breas Medical, Inc.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-10-03
Study Completion Date2025-08-07

Study Record Updates

Study Start Date2024-10-03
Study Completion Date2025-08-07

Terms related to this study

Keywords Provided by Researchers

  • Sleep Apnea
  • Non-Invasive Ventilation (NIV)
  • Respiratory Failure
  • Polysomnography
  • Apnea-Hypopnea Index (AHI)
  • Expiratory Positive Airway Pressure (EPAP)

Additional Relevant MeSH Terms

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