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Smart breathing machines at home: a new way to predict COPD crises?

NCT ID NCT02811588

Disease control Sponsor: ResMed 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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 14, 2026 · Last updated Aug 14, 2026

Summary

This study looks at whether using a breathing machine (non-invasive ventilation) at home, with remote monitoring, can help people with advanced COPD avoid hospital visits. It tracks how often patients need unplanned hospital care and whether the monitoring data can predict problems early. The goal is to see if this approach improves daily life and reduces the burden on healthcare systems.

What this could mean

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

Active substance
Non-invasive ventilation (NIV) with home tele-monitoring
What this could lead to
If successful, this could lead to better ways to monitor COPD patients at home, potentially reducing hospitalizations and improving quality of life.
What could go wrong
The study is observational and early, so it may not prove that tele-monitoring improves outcomes. Also, remote monitoring might not reliably predict all health declines.

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

169 people

The number who actually took part.

Started

Jul 2016

Finished

Dec 2024

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

Approximately 550 adult female and male patients with COPD eligible for NIV treatment will be enrolled, out of which 231 patients have been enrolled within the phase 1 of the study. If a patient is enrolled into the study but is never using the prescribed device (i.e. refusal of prescribed therapy) he/she will be replaced. If a patient, who has already started NIV therapy, is enrolled, the start of therapy must not be longer than 7 days before enrolment. Within this study population, data of a maximum of about 100 patients will be added by the French ANTADIR registry in line with in- and exclusion criteria of this observational study.

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.

Phase1:Inclusion Criteria: * Age ≥18 years * GOLD stage 3 or 4 COPD * pCO2 value available not older than one month * Ability to fully understand the study information and willing to give informed consent Phase2: Age ≥18 years COPD eligible for NIV treatment (according to applicable medical guidelines and local policy in routine clinical care) Prescription of an adequate ResMed NIV device with tele-monitoring option (according to Annex 1, 3.) as part of routine clinical care Acceptance of tele-monitoring and corresponding data handling Naive to long-term NIV treatment with initiation of NIV either ≤7 days before or after enrolment into study Able to fully understand information on data protection and provide written informed consent for use of corresponding medical and telemetric data. Phase1:Exclusion Criteria:Existing treatment with NIV Phase2:Exclusion Criteria Invasive ventilation therapy Another life-threatening disease with estimated survival \< 12 months (other than COPD, e.g. cancer) Further exclusion criteria according to IFU of the device intended and prescribed

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Conditions

The condition(s) this trial relates to.

chronic obstructive pulmonary disease

As listed by the trial registrant

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

Chronic obstructive pulmonary disease

Contacts and locations

Locations

  • Clemenshospital

    Münster, Westfalen Lippe, 48153, Germany

  • Kliniken der Stadt Köln

    Cologne, 51109, Germany

  • Marienkrankenhaus gGmbH

    Soest, Westfalen Lippe, 59494, Germany

  • Universitätsklinikum Aachen

    Aachen, North Rhine-Westphalia, 52074, Germany

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