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Smart ventilator feature aims to ease nighttime breathing problems

NCT ID NCT06560411

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

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

23 people

The number who actually took part.

Started

Oct 2024

Finished

Aug 2025

Lead sponsor

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

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

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

  • Bogan Sleep Consultants

    Columbia, South Carolina, 29201, United States

  • Delta Waves

    Colorado Springs, Colorado, 80918, United States

  • Insomnia and Sleep Institute of Arizona, LLC

    Scottsdale, Arizona, 85255, United States

  • University of California San Diego

    San Diego, California, 92121, United States

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