Evaluation of a New Nasal Pillows Mask for the Treatment of Obstructive Sleep Apnea

Fisher & Paykel Healthcare

Status

Withdrawn

Conditions

Obstructive Sleep Apnea

Treatments

Device: New nasal pillows mask with PAP therapy

Study type

Interventional

Funder types

Industry

Identifiers

NCT04063436

CIA-264

Details and patient eligibility

About

This clinical trial is designed to evaluate the performance, comfort, and usability of a new nasal pillows mask for the treatment of obstructive sleep apnea (OSA) in a home environment.

Sex

All

Ages

22+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Are ≥22 years of age
Weigh ≥66 lbs
Have been formally diagnosed with OSA by a physician
Have an AHI ≥5 on a diagnostic night
Have been prescribed PAP therapy to treat OSA by a physician
Are an existing nasal pillows mask user
Have been using a nasal pillows mask for ≥3 months prior to enrolment into the study
Are compliant with PAP therapy for ≥4 hours per night for 70% of nights
Are fluent in spoken and written English
Possess the capacity to provide informed consent

Exclusion criteria

Are intolerant to PAP therapy
Possess, or suffer from, anatomical or physiological conditions which make PAP therapy inappropriate
Are currently diagnosed with respiratory disease or CO2 retention
Are pregnant or think they may be pregnant
Have an IPAP pressure of >25 cmH2O
Persons who use a PAP therapy machine for the delivery of medicines, except O2
Use a PAP therapy machine that does not possess data recording capabilities to capture AHI and leak information that is accessible to OSMI