This investigation is a prospective, non randomized, non blinded study. This investigation is designed to evaluate the performance, comfort and ease of use with the F\&P trial nasal mask amongst Obstructive Sleep Apnea (OSA) patients.
Visit 1 will involve the participants consented in to the trial. Visit 2 will involve the participants being fitted with the F\&P trial nasal mask for use in-home. The participant will then come in to return the mask (Visit Three) and have a final interview, this ensures the maximum time participants will be exposed to the trial mask in home will be 14 ± 4 days from visit two. The mask will be returned to the Institution at the conclusion of the trial and the participant will return to their previous mask. The Institution will recruit all patients within 1 week of the beginning of the study.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
30
Investigative Nasal Mask to be used for OSA therapy
Hastings Memorial Hospital
Hastings, New Zealand
WellSleep
Wellington, New Zealand
Ease of use
Subjective Questionnaire
Time frame: 2 weeks
Acceptability
Subjective Questionnaire
Time frame: 2 weeks
Objective leak data
Data obtained from participant's device - Objective
Time frame: 2 weeks
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