Smart ventilator feature aims to ease nighttime breathing problems
NCT ID NCT06560411
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tested a new automatic setting (Auto-EPAP) on a ventilator to see if it could better manage airway blockages during sleep compared to the standard manual setting. It involved 23 adults with conditions like sleep apnea, COPD, or obesity-related breathing problems who already used a ventilator. The goal was to improve oxygen levels and reduce breathing pauses without causing serious side effects.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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23 people
The number who actually took part.
- Started
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Oct 2024
- Finished
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Aug 2025
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Bogan Sleep Consultants
Columbia, South Carolina, 29201, United States
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Delta Waves
Colorado Springs, Colorado, 80918, United States
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Insomnia and Sleep Institute of Arizona, LLC
Scottsdale, Arizona, 85255, United States
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University of California San Diego
San Diego, California, 92121, United States
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