Can a home breathing machine ease severe COPD?
NCT ID NCT07777497
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
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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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14 people
The number who actually took part.
- Started
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Jan 2024
- Finished
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Oct 2024
- Lead sponsor
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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
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Children (under 18), adults (18 to 64) and older adults (65 and over)
- 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.
Show the full entry requirements Hide 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.
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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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Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung City, Sanmin Dist, 807, Taiwan
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