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Evaluation of a Full Face Mask and Headgear for the Treatment of Obstructive Sleep Apnea

Fisher and Paykel Healthcare · 2014
ClinicalTrials.gov · Datasets · License: Public Domain · 2014
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naobstructive-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.
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