Can a home breathing machine ease severe COPD?

NCT ID NCT07777497

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 20, 2026 · Last updated Aug 21, 2026 · Updated 1 time

Summary

This trial tests whether a home breathing support program, guided by respiratory therapists, is practical and helpful for people with severe COPD who do not have high carbon dioxide levels. Participants use a bilevel positive airway pressure device at home for at least 6 hours a day for 3 months. Researchers will measure changes in breathing symptoms, walking ability, lung function, and overall health status to see if the program is worth pursuing.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
BreathePal Bilevel Positive Pressure System (a home breathing support device)
What this could lead to
If this approach works, it could offer a practical home-based breathing support option for people with severe COPD, potentially improving their breathing symptoms and quality of life.
What could go wrong
This is a very small feasibility study, so results may not apply to everyone. The device may be uncomfortable or hard to tolerate, and it's unclear if it will provide meaningful benefits for those without high carbon dioxide levels.

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

14 people

The number who actually took part.

Started

Jan 2024

Finished

Oct 2024

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

Children (under 18), adults (18 to 64) and older adults (65 and over)

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: * Adults aged 20 years or older. * Diagnosis of severe chronic obstructive pulmonary disease (COPD). * Post-bronchodilator FEV1/FVC \< 0.70. * FEV1 \< 50% of the predicted value with at least one moderate or severe COPD exacerbation in the previous year; or FEV1 50%-80% of the predicted value with at least two moderate exacerbations or at least one severe exacerbation in the previous year. * Able to breathe spontaneously and not dependent on continuous bilevel positive airway pressure ventilation for life support. * No acute myocardial infarction or life-threatening cardiac arrhythmia. * No acute facial injury. * No indication for an artificial airway for conditions such as secretion clearance or upper airway obstruction. Exclusion Criteria: * Pregnancy or suspected pregnancy. * Hemodynamic instability. * Recent facial surgery. * Excessive or excessively thick respiratory secretions. * Sleep apnea. * Other causes of chronic airway obstruction, such as bronchiectasis. * Significant comorbid disease, such as left ventricular failure. * Contraindications to noninvasive positive-pressure ventilation, including acute sinusitis, otitis media, pneumothorax, pathological hypotension, dehydration, cerebrospinal fluid leak, or recent cranial surgery or trauma.

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for COPD are added.

Our safety recommendation!

By submitting, you agree to our Terms of use

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

  • Kaohsiung Medical University Chung-Ho Memorial Hospital

    Kaohsiung City, Sanmin Dist, 807, Taiwan

More trials for these conditions

Other studies related to the condition(s) this trial covers.