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New mask aims to make sleep apnea therapy easier to live with

NCT ID NCT07826429

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Sep 17, 2026 · Last updated Sep 18, 2026 · Updated 1 time

Summary

Researchers are testing the F&P Licorice mask, a device used with PAP or NIV breathing machines, in people who have obstructive sleep apnea or other chronic respiratory conditions. The study follows about 45 adults who already use this type of therapy at home. Over roughly two weeks, the team measures breathing pauses during sleep, daytime sleepiness, and how patients and clinicians rate the mask's performance, safety, and comfort.

What this could mean

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

Active substance
F&P Licorice mask, a PAP/NIV therapy mask
What this could lead to
If the mask performs well, it could give people who use PAP or NIV therapy another comfortable option for breathing support at home.
What could go wrong
This is a device study, not a cure, and it may show the mask works no better than existing masks. Comfort and fit vary from person to person, so results may not apply to 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 45 people

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

Expected to start

Sep 2026

An estimate. Start dates often move.

Expected to finish

Jun 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

22 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: * Are ≥22 years of age * Weigh ≥66 pounds * Have been prescribed PAP/NIV therapy by a physician * Are an existing PAP/NIV therapy mask user with ≥3 months of use prior to enrolment in the clinical investigation\* * Are compliant with PAP/NIV therapy for ≥4 hours per night for ≥70% of nights for a 14-day period within 30 days prior to enrolment in the clinical investigation * Are fluent in spoken and written English * Possess the capacity to provide informed consent Exclusion Criteria: * Are intolerant to PAP/NIV therapy * Possess, or suffer from, anatomical or physiological conditions which make PAP/NIV therapy inappropriate * Are required to use PAP/NIV therapy for \>12 hours per day or for extensive periods, not including sleep or naps * Are trying to get pregnant, are pregnant, or think they may be pregnant * Have an IPAP pressure of \>30 cmH2O if on BPAP * Use a PAP/NIV therapy device for the delivery of medicines, except supplemental O2 * Use a PAP/NIV therapy device that does not possess data recording capabilities to capture AHI and a numerical indicator of leak that is accessible to the clinical investigation site * Have a history of light-induced seizures (for optional anthropometric scan only)

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Conditions

The condition(s) this trial relates to.

obstructive sleep apnea syndrome

As listed by the trial registrant

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

Chronic respiratory conditions Obstructive sleep apnea (OSA)

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

  • Clayton Sleep Institute

    St Louis, Missouri, 63123, United States

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