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

Withdrawn before enrolling · Not applicable

Conditions studied: Obstructive Sleep Apnea

In brief

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.

Key facts

Study ID

NCT04063436

Run by

Fisher and Paykel Healthcare

People needed

0

Starts

2019-09-23

Expected to finish

2019-10-11

Last updated by the study team

2020-03-23

Who can join

Age: 22 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Ohio Sleep Medicine Institute — Dublin, Ohio, United States

Full record on ClinicalTrials.gov

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