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New sleep apnea mask put to the test at home

NCT ID NCT05573763

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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 26, 2026 · Last updated Jun 26, 2026

Summary

This study tested a new nasal pillows mask called F&P Toffee for people with obstructive sleep apnea. Forty adults who already use PAP therapy tried the mask at home for 14 days. Researchers measured how well the mask controlled breathing pauses (AHI score) and how sleepy participants felt during the day. The goal was to see if the mask is safe and effective for home use.

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 Toffee nasal pillows mask (device)
What this could lead to
If successful, this mask could offer a more comfortable option for people with sleep apnea who use PAP therapy, potentially improving adherence and sleep quality.
What could go wrong
This is a small, early-stage device trial with only 40 participants and no comparison group. The results may not apply to all mask users, and individual comfort varies.

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

40 people

The number who actually took part.

Started

Nov 2022

Finished

Jun 2023

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: * Persons who are ≥22 years of age * Persons who weigh ≥66 pounds * Persons who have been prescribed PAP therapy by a physician * Persons who are existing nasal pillows mask users with at ≥3 months of use prior to enrolment in the clinical trial * Persons who are compliant with PAP therapy for ≥4 hours per night for ≥70% of nights for a 14-day period within 30 days prior to enrolment in the clinical trial * Persons who are fluent in spoken and written English * Persons who possess the capacity to provide informed consent Exclusion Criteria: * Persons who are intolerant to PAP therapy * Persons who possess, or suffer from, anatomical or physiological conditions which make PAP therapy inappropriate * Persons who are required to use PAP therapy for \>12 hours per day or for extensive periods, not including sleep or naps * Persons who are trying to get pregnant, are pregnant, or think they may be pregnant * Persons who have an IPAP pressure of \>25 cmH2O if on BPAP * Persons who use a PAP therapy device for the delivery of medicines, except supplemental O2 * Persons who use a PAP therapy device that does not possess data recording capabilities to capture AHI and a numerical indicator of leak that is accessible to the investigation site

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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.

Obstructive sleep apnea

Contacts and locations

Locations

  • Ohio Sleep Medicine Institute

    Columbus, Ohio, 43017, United States

More trials for these conditions

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