F&P Mask for Sleep Apnea
What You Need to Know Before You Apply
What is the purpose of this trial?
This clinical investigation is designed to validate and confirm the overall performance, safety, usability, reliability, and acceptability of the F\&P mask in a home environment.
Are You a Good Fit for This Trial?
This trial is for people diagnosed with COPD or sleep apnea who use masks at home to help them breathe. Participants should be able to use the mask as directed and live in a home setting.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants use the F&P mask in a home environment to assess performance, safety, usability, reliability, and acceptability
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Trial Overview
The study is testing the F&P mask, a device worn over the nose or mouth to help with breathing during sleep, checking how well it works, how safe it is, and if users find it comfortable and reliable at home.
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
Single-arm, non-randomised, open-label
Find a Clinic Near You
Who Is Running the Clinical Trial?
Fisher and Paykel Healthcare
Lead Sponsor
Dr. Justin Vaughan
Fisher and Paykel Healthcare
Chief Medical Officer since 2024
MD from the University of Auckland
Lewis Gradon
Fisher and Paykel Healthcare
Chief Executive Officer since 2016
Bachelor of Science in Physics from the University of Auckland, New Zealand
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