Evaluation of the F&P Mask, US, 2026

Fisher & Paykel Healthcare

Status

Enrolling

Conditions

Obstructive Sleep Apnea (OSA)

Chronic Respiratory Conditions

Treatments

Device: F&P Licorice Mask

Study type

Interventional

Funder types

Industry

Identifiers

NCT07826429

CIA-367

Details and patient eligibility

About

This clinical investigation is designed to validate and confirm the overall performance, safety, usability, reliability, and acceptability of the F&P PAP mask in a home environment.

Enrollment

45 estimated patients

Sex

All

Ages

22+ years old

Volunteers

No Healthy Volunteers

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)