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New mask aims to reduce breathing effort in ventilation patients

NCT ID NCT07484802

Symptom relief Sponsor: Fisher and Paykel Healthcare 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests a redesigned non-invasive ventilation mask that may help people with respiratory insufficiency breathe more easily. Sixty adults who are stable on NIV will wear their usual mask for one hour and then the new mask for one hour. Researchers will measure breathing rate, air leak, and comfort to see if the new mask performs better.

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 mask with airway washout
What this could lead to
If it works, this new mask could make breathing easier and more comfortable for people who need non-invasive ventilation.
What could go wrong
This is a small, early-stage study with only 60 participants, each using the mask for just one hour. It may not show a meaningful benefit or work for everyone.

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

About 60 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 2027

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.

Ages

21 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: * Adults that are stable on prescribed NIV * Able to receive NIV therapy on a sub-nasal mask * Are 21 years old or older Exclusion Criteria: * Contraindicated for NIV * NIV is likely to fail and/or intubation be required, at the doctor's discretion * CPAP or bilevel pressure of ≥ 30 cmH2O required * Do not fit the investigation mask or the standard mask * Pregnancy (tested under standard care) * Unable to tolerate NIV for the duration of the investigation * Unable to understand the consent process

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Conditions

The condition(s) this trial relates to.

respiratory failure

As listed by the trial registrant

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

Respiratory failure Respiratory insufficiency

How to take part

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

  1. 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 ↗

  2. 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.

More trials for these conditions

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