F&P Mask usability in home PAP/NIV care for adults with chronic breathing conditions

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This interventional study aims to validate performance, safety, usability, reliability, and acceptability of the F&P Licorice PAP mask in a home setting for adults with chronic respiratory conditions, including obstructive sleep apnea. Eligible participants are existing PAP/NIV users who meet usage and literacy criteria and are evaluated in a real-world environment. The study focuses on adherence, user experience, and basic safety outcomes to support potential device adoption. Recruitment is centralized at Clayton Sleep Institute in St. Louis, under Fisher and Paykel Healthcare as the lead sponsor. No collaborators are listed.

Why it matters

Who can join: the full rules

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)

Where it's running

• Clayton Sleep Institute
  St Louis, Missouri, United States Recruiting

Study contacts

• Study coordinator: Clinical Research Scientist
• Email: cpap.trial@fphcare.co.nz
• Phone: +6421436485

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.