Obstructive Sleep Apnea Clinical Trial
Official title:
The Evaluation of an Alternative Sizing Model in Comparison of a Conventional Sizing Model for Full-face Masks in the Treatment of OSA in Terms of Performance and Comfort
The investigation is a prospective non-blinded and semi-randomized clinical investigation. The investigation is designed to assess the alternative sizing model which the trial mask concept is based on and how it compares to a conventional sizing present in the Prototype Full Face Mask (PFFM) mask.
The investigation is a prospective non-blinded and semi-randomized investigation. The
investigation is designed to assess the alternative sizing model which the trial mask concept
is based on and how it compares to a conventional sizing present in the Prototype Full Face
Mask (PFFM) mask. A cohort of up to 38 pre-determined current nasal and full face mask users
will be recruited by Fisher & Paykel Healthcare in Auckland New Zealand, Waikato DHB in
Hamilton New Zealand, Hawkes Bay DHB in Hastings New Zealand and WellSleep Centre in
Wellington New Zealand.
The study will involve baseline (visit one) gathering the participants' prescribed PAP
therapy pressure and their usual mask (to have up-to-date records). The next visit (visit 2)
7 ± 4 days after visit 1, the participants will be fit the Prototype Full Face Mask (PFFM)
mask or the alternative sizing based trial mask. At visit 3, which will be after 7 ± 4 days
from visit 2, the participants will be crossed over to the mask. At visit 4, 7 ± 4 days after
visit 3, all masks and devices will be collected from the participants.
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