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Can new home monitors keep tabs on breathing support without a clinic visit?

NCT ID NCT05698602

Knowledge-focused Sponsor: VIVARDIS 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
The trial has finished. Results may not be published yet.
Stopped early This study
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This status has not been confirmed recently, so it may be out of date.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 Sep 02, 2026 · Last updated Sep 03, 2026 · Updated 1 time

Summary

This trial tests two new devices, NivolisMonitor and NivolisAnton, designed for people who use breathing support at home, such as non-invasive ventilation or high-flow nasal oxygen. NivolisMonitor measures breathing parameters like pressure, flow, and oxygen levels, while NivolisAnton tracks carbon dioxide through the skin. Researchers will compare the devices' readings with standard equipment to check they are safe and accurate. Ten patients will use the devices at home for three days, and the study also asks patients and healthcare professionals about how easy the devices are to use.

What this could mean

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

Active substance
NivolisMonitor and NivolisAnton are two medical devices for home monitoring. NivolisMonitor measures breathing parameters like pressure, flow, and oxygen. NivolisAnton tracks carbon dioxide levels through the skin.
What this could lead to
If the devices work well, they could let doctors track breathing support at home more easily, reducing the need for clinic visits and improving care for people with respiratory failure.
What could go wrong
This is a very small early study with only 10 patients, so results may not apply to everyone. The devices might not match the accuracy of existing monitors, and technical issues could arise during home use.

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

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

10 people

The number who actually took part.

Started

Apr 2023

Finished

Aug 2026

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.

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: * Patients treated with home ventilatory devices: NIV (Philipps Dreamstation or Resmed Lumis) or HDN * COPD patient treated with NIV or HDN according to current recommendations * Patient with Obesity Hypoventilation Syndrome treated with NIV or HDN according to current recommendations Exclusion Criteria: * Progressive and life-threatening condition in the short term (1 year) (cancer, rapidly progressing neuromuscular disease) (at physician's discretion) * Patients treated with NIV other than Philipps Dreamstation or Resmed Lumis * Hospitalization leading to NIV discontinuation for at least 1 week during the screening phase * Person deprived of liberty * Adult protected by law * Pregnant and breastfeeding women

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Conditions

The condition(s) this trial relates to.

COPD, severe early onset obesity-hypoventilation syndrome respiratory failure

As listed by the trial registrant

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

Home monitoring Respiratory failure Respiratory insufficiency

Contacts and locations

Locations

  • CHU Grenoble Alpes

    Grenoble, 38, France

More trials for these conditions

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