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Nighttime breathing clues may predict COPD treatment success

NCT ID NCT07414108

Knowledge-focused Sponsor: IRCCS Azienda Ospedaliero-Universitaria di Bologna Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study follows 25 people with COPD and high carbon dioxide levels who use a breathing machine at night. Researchers want to see if nighttime breathing problems can predict how well the machine works over 6 to 12 months. They will also check lung function, diaphragm health, and how often patients need hospital care. The goal is to better understand who benefits most from this therapy.

What this could mean

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

What this could lead to
If successful, this could help doctors identify which COPD patients will benefit most from non-invasive ventilation, leading to more personalized treatment.
What could go wrong
This is a small observational study with only 25 participants, so results may not apply to everyone. It is designed to gather information, not to test a new treatment.

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.

Participants

About 25 people

The number the study aims to enrol. It can still change while the study runs.

Started

Dec 2025

Expected to finish

Jun 2028

An estimate. End dates often move.

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.

Who is studied

The study population consists of patients with COPD and hypercapnic respiratory failure who require NIV and who are evaluated in the outpatient clinic and/or inpatient unit of the Respiratory and Critical Care Unit of the IRCCS AOU of Bologna.

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: * Age ≥ 18 years * Patients with COPD and hypercapnia, defined as PaCO₂ \> 50 mmHg either chronically or 4 weeks after an acute exacerbation requiring invasive or non-invasive mechanical ventilation * Provision of informed consent Exclusion Criteria: * Progressive neurodegenerative diseases * Diaphragmatic disorders * Severe hemodynamic instability (\>1 vasoactive agent for at least 24 hours) * Acute coronary syndrome (unstable angina / myocardial infarction) * Severe arrhythmias * Presence of contraindications to NIV * Cognitive impairment interfering with treatment adherence * Active and unstable coronary artery disease * Malignancies undergoing active treatment * Patients already receiving home non-invasive mechanical ventilation

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Conditions

The condition(s) this trial relates to.

chronic obstructive pulmonary disease COPD, severe early onset Hypercapnia respiratory failure

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

COPD COPD (chronic obstructive pulmonary disease) Hypercapnia Hypercapnic respiratory failure, COPD

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • IRCCS Azienda Ospedaliero-Universitaria di Bologna

    RECRUITING

    Bologna, 40138, Italy

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