The Evaluation of the Toffee Nasal Pillows Mask for the Treatment of Obstructive Sleep Apnea

Study Overview
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Brief Summary
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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)

Detailed Description
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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.

Official Title
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The Evaluation of the Toffee Nasal Pillows Mask for the Treatment of Obstructive Sleep Apnea

Conditions
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Obstructive Sleep Apnea

Intervention / Treatment
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* Device: Toffee Nasal Pillows Mask


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult (22+ years of age) Able to give informed consent Apnea hypopnea Index (AHI) ≥ 5 on diagnostic night Either prescribed Automatic positive airway pressure (APAP), Continuous positive airway pressure (CPAP) or Bi-level positive airway pressure (PAP) for OSA Fluent in spoken and written English Existing nasal pillows mask user Exclusion Criteria: Inability to give informed consent Participant intolerant to PAP Anatomical or physiological conditions making PAP therapy inappropriate Current diagnosis of respiratory disease or carbon Dioxide (CO2) retention Pregnant or may think they are pregnant.

Ages Eligible for Study
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Minimum Age: 22 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Toffee Nasal Pillows Mask<br>Participants will be placed on this arm for a total of 14 +- 5 days from visit 2. participants will be using the Toffee mask during this treatment arm | Device: Toffee Nasal Pillows Mask<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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 | 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 | 14 ± 5 days in-Home | 
| Trial Mask Acceptability | Participant count regarding whether they would continue using the trial mask if given the choice. | 14 ± 5 days in-Home | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 14 ± 5 days in-Home |