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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
11
Fisher & Paykel Healthcare Ltd.
Auckland, East Tamaki, New Zealand
The mask is comfortable and is effective for the participant during in-home use
Performance in relations to leak and comfort of each prototype and how it compares to their usual mask, as measured by a custom questionnaire, daily participant feedback log and PAP device data.
Time frame: 1 week for each mask prototype in-home
Acceptability of the Full Face mask prototypes
Preference for one of the Full Face Mask prototypes design through a custom questionnaire and a daily participant feedback log
Time frame: 1 week for each mask prototype in-home
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