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Smart ventilators: a new era for breathing therapy?

NCT ID NCT07768748

Knowledge-focused Sponsor: Löwenstein Medical Technology GmbH & Co. KG 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 17, 2026 · Last updated Aug 26, 2026 · Updated 3 times

Summary

This study investigates how well two non-invasive ventilation devices, prisma VENT and LUISA, can automatically detect patient-ventilator asynchronies—when a patient's breathing and the machine's support fall out of sync. Researchers will monitor 78 adults during routine therapy setup or follow-up visits, comparing the devices' automatic detection against standard sleep study recordings. The goal is to understand the types and patterns of these mismatches and how they affect therapy adjustments, potentially leading to smarter, more responsive ventilators.

What this could mean

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

Active substance
prisma VENT and LUISA non-invasive ventilation devices
What this could lead to
If successful, this could lead to better ventilator algorithms that automatically detect and reduce breathing mismatches, improving comfort and therapy effectiveness for patients on non-invasive ventilation.
What could go wrong
This is an observational study, so it won't directly test a new treatment. The findings may not apply to all ventilator types or patient groups, and the accuracy of automatic detection may vary.

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 78 people

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

Started

Aug 2026

Expected to finish

Dec 2028

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

Patients with an indication for non-life-sustaining or life-sustaining NIV therapy (initial setup or follow-up visit) treated with a prisma VENT or LUISA ventilator.

Ages

18 to 80 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: * indication for non-life-sustaining or life-sustaining NIV therapy (initial setup) or an existing non-life-sustaining or life-sustaining NIV therapy * treatment with a prisma VENT or LUISA therapy device according to clinical routine * age of study participants: ≥ 18 and ≤ 80 years * capacity to give consent * availability of a signed informed consent form for participation in the clinical trial and a signed consent form for data use in accordance with the GDPR Exclusion Criteria: * presence of a contraindication to NIV therapy * participation in another clinical investigation that affects the initiation of NIV therapy through specifications regarding device settings or titration * pregnancy or breastfeeding

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Conditions

The condition(s) this trial relates to.

Patient-Ventilator Asynchrony

As listed by the trial registrant

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

Patient ventilator interactions

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

  • Fachkrankenhaus Kloster Grafschaft GmbH

    RECRUITING

    Schmallenberg, North Rhine-Westphalia, 57392, Germany