Obstructive Sleep Apnea Clinical Trial
Official title:
The Evaluation of a Novel Nasal Mask for the Treatment of Obstructive Sleep Apnea
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.
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