Obstructive Sleep Apnea Clinical Trial
Official title:
Evaluation of a Full Face Mask and Headgear for the Treatment of Obstructive Sleep Apnea
Currently Fisher & Paykel Healthcare (FPH) is developing a new full face mask. The objective
of this clinical investigation is to evaluate the usability and acceptance of the
investigative mask, the effectiveness of the seal and headgear.
The participant will be randomised to use either full face mask prototype 1 or 2 as
according to the randomization log for 7 ± 3 days in home. The participant will then
crossover to the other full face mask prototype to use in home for 7 ± 3 days. Neither the
investigators or the participants will be blinded to the study.
n/a
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
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