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Smart breathing machines at home could cut hospital visits for COPD patients

NCT ID NCT07679646

Disease control Sponsor: Air Liquide Healthcare Spain Source: ClinicalTrials.gov ↗

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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 01, 2026 · Last updated Jul 02, 2026 · Updated 1 time

Summary

This study looks at whether adding a home telemonitoring system to standard nighttime breathing support (non-invasive ventilation) can help people with severe COPD and high carbon dioxide levels. About 92 participants will be split into two groups: one using standard home ventilation alone, and another using ventilation plus a device that sends daily data (like air leaks and breathing rates) to their healthcare team. The goal is to see if remote monitoring can prevent severe flare-ups and reduce the number of days spent in the hospital over one year.

What this could mean

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

Active substance
Home non-invasive ventilation with telemonitoring
What this could lead to
If successful, this approach could reduce hospital stays and improve daily life for people with severe COPD, while also lowering healthcare costs.
What could go wrong
This is a relatively small study (92 people) and telemonitoring may not significantly change outcomes. Technical issues or patient non-compliance could also limit effectiveness.

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 92 people

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

Expected to start

Jul 2026

An estimate. Start dates often move.

Expected to finish

Dec 2026

An estimate. End dates often move.

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.

Who is studied

The study population consists of adult patients diagnosed with severe, stable Chronic Obstructive Pulmonary Disease (COPD) and chronic persistent hypercapnia, who are managed and followed at public university hospitals within the Community of Madrid, Spain, and who have a recent history of frequent acute respiratory exacerbations.

Ages

50 to 90 years

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. Age between 50 and 90 years. 2. Confirmed diagnosis of Chronic Obstructive Pulmonary Disease (COPD) according to current Global Initiative for Chronic Obstructive Lung Disease (GOLD) criteria, demonstrating non-fully reversible airflow limitation with a Forced Expiratory Volume in 1 second (FEV1) \< 50% of the predicted value confirmed by spirometry. 3. Persistent hypercapnia, defined as PaCO2 \> 53 mmHg documented for at least two weeks following an acute COPD exacerbation. 4. History of two or more acute COPD exacerbations within the preceding year. 5. Signed written informed consent. Exclusion Criteria: 1. Prior ongoing treatment with home non-invasive ventilation (NIV) or Continuous Positive Airway Pressure (CPAP). 2. Severe obstructive sleep apnea (OSA), defined as an Apnea-Hypopnea Index (AHI) \>= 30. 3. Inability of the patient or the primary caregiver to comprehend or operate the telemonitoring and NIV procedures. 4. Estimated life expectancy of less than one year. 5. Terminal heart failure (New York Heart Association \[NYHA\] Class III-IV) or unstable angina. 6. Advanced renal insufficiency (creatinine clearance \< 30%) or inclusion in an active dialysis program. 7. Hepatic cirrhosis or active inclusion in a liver transplant program. 8. Severe psychiatric illness requiring antipsychotic medication, active ongoing treatment for substance or alcohol addiction, or lack of a fixed home address upon hospital discharge. 9. Receipt of home palliative care. 10. Institutionalization. 11. Classification by the attending physician as non-compliant with medical therapies, treatments, or study protocols

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Conditions

The condition(s) this trial relates to.

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

As listed by the trial registrant

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

Hypercapnia Pulmonary disease, chronic obstructive (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

  • Hospital General Universitario Gregorio Marañón

    Madrid, Madrid, 28007, Spain

More trials for these conditions

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