Evaluation of the F&P Caramel Nasal Mask, US, 2023

Fisher & Paykel Healthcare

Status

Completed

Conditions

Obstructive Sleep Apnea

Treatments

Device: F&P Caramel

Study type

Interventional

Funder types

Industry

Identifiers

CIA-337

Details and patient eligibility

About

The purpose of this clinical investigation is to evaluate the performance and safety of the F&P Caramel nasal mask in a home environment.

Enrollment

45 patients

Sex

All

Ages

22+ years old

Volunteers

No Healthy Volunteers

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 mask or sub-nasal mask users with ≥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 >30 cmH2O if on BPAP
Persons who use a PAP therapy device for the delivery of medicines, except supplemental oxygen
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