This investigation is a prospective, non-randomized, non-blinded study. This investigation is designed to evaluate the performance, comfort and ease of use of the F\&P Toffee nasal pillows mask amongst obstructive sleep apnea (OSA) patients. Up to 45 OSA patients will be recruited from the Ohio Sleep Medical Institute (OSMI)
Visit 1 will involve the participants being consented into the trial. Visit 2 will involve the participants being fitted with the F\&P Toffee nasal pillows 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 Toffee 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
38
Participants will be placed on this intervention for a total 14 ± 5 days from Visit 2. Participants will be using the Toffee nasal pillows mask during this treatment arm.
Ohio Sleep Medicine Institute
Dublin, Ohio, United States
Toffee Mask Usability
Questionnaire on usability during second visit - Subjective. Participants rated overall usability of the mask on a 5 point likert type scale ranging from very easy, easy, neither, difficult or very difficult.
Time frame: 14 ± 5 days in-Home
Toffee Mask Comfort
Determine from questionnaires - Subjective Participants rated overall comfort of the mask by indicating on a 5 point likert type scale the degree of comfort they felt. Answer responses ranges from very good, good, neither, poor, or very poor
Time frame: 14 ± 5 days in-Home
Toffee Mask Treatment Performance - Subjective
Determined from questionnaires - Subjective Participants rated overall performance of the mask on a 5 point likert type scale with responses including very good, good, neither, poor, or very poor
Time frame: 14 ± 5 days in-Home
Trial Mask Acceptability
Participant count regarding whether they would continue using the trial mask if given the choice.
Time frame: 14 ± 5 days in-Home
Toffee Mask Treatment Performance - Objective
Objective data recorded from PAP device - Objective Apnea hypopnea index (AHI) data extracted from participants therapy efficacy reports was used to assess this outcome. AHI is a measure of disease severity and is used to evaluate treatment efficacy. Data was reported as a "pass" or "fail" based on the change in AHI from baseline to the intervention. If AHI increased by a clinically significant amount (as reviewed by the PI/study staff) this was marked as a fail.
Time frame: 14 ± 5 days in-Home
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