The Evaluation of the Toffee 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 mask amongst Obstructive Sleep Apnea (OSA) patients. Up to 45 OSA patients will be recruited from the Pulmonary Disease Specialists Research database.

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 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 2 weeks of the beginning of the study.

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

Conditions
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Obstructive Sleep Apnea

Intervention / Treatment
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* Device: Toffee Full Face 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 OSA 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 Full Face Mask<br>Participants will be placed on this arm for a total of 14+- 4 days from visit 2. Participants will be using the Toffee mask during this treatment arm. | Device: Toffee Full Face Mask<br>* Participants will be placed on this arm for a total of 14+- 4 days from visit 2. Participants will be using the Toffee 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 Acceptability | Participant preference for the Toffee mask over their usual mask. Determined from questionnaires -Subjective | 14±4 days in home | 
| Toffee Mask Comfort | Overall Toffee mask comfort determined from questionnaires-Subjective | 14±4 days in home | 
| Toffee Mask Treatment Seal Performance-Subjective | Sealing performance of Toffee mask determined from questionnaires - Subjective | 14±4 days in home | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Toffee Mask Treatment Performance-Objective | Objective Apnea Hypopnea Index (AHI) data recorded from the participants Positive Airway Pressure (PAP) device and compared to baseline AHI data - Objective | 14±4 days in home |