A Development Study to Evaluate a Full-Face Mask for the Treatment of Obstructive Sleep Apnea

Study Overview
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Brief Summary
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This investigation is designed to evaluate the comfort, ease of use and performance of a trial nasal mask for the treatment of Obstructive Sleep Apnea (OSA) in the home environment.

Detailed Description
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This investigation is a prospective, non-randomized, non-blinded study. Up to 45 OSA participants who currently use a full-face mask will be recruited. This study will involve a baseline (Visit One) data gathering with the participant's positive airway pressure (PAP) therapy and their usual mask. This will be followed by the participants being fitted with the trial full-face mask for use in-home (Visit Two). The participant then will come in to return the mask (Visit Three) and give their feedback on their experience using the mask in home in the form of a structured interview during Visit Three. The maximum amount of time the participants will be exposed to the trial mask in-home will be 14 ± 5 days from Visit Two. The mask and CPAP (if used from the research pool) will be returned to the institution at the conclusion of the trial and participant will return to their usual mask and therapy device for the treatment of their Obstructive Sleep Apnea. Neither the investigators nor the participants will be blinded to the study.

Official Title
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A Development Study to Evaluate a Full-Face Mask for the Treatment of Obstructive Sleep Apnea

Conditions
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Obstructive Sleep Apnea

Intervention / Treatment
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* Device: F&P Toffee mask


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: AHI ≥ 5 from the diagnostic night Aged 22 and over (FDA defined as default) Either prescribed APAP, CPAP or Bi-level PAP for OSA Existing Full-Face mask user Fluent in spoken and written English 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 CO2 retention Pregnant or think they may be 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
Interventional Model Description: After a period of baseline, all enrolled participants will be put on the same trial mask.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: F&P Toffee mask<br>Participants will be placed on this arm for a total of 14 ± 5 days from Visit two. Participants will be using the trial full-face mask during this treatment arm. | Device: F&P Toffee mask<br>* Trial Full-Face mask which comes with three seal sizes and two headgear sizes.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Trial Mask Comfort | Comfort comparison of trial mask compared to their usual mask. Determined from custom questionnaires - Subjective | 14 ± 5 days In-Home | 
| Trial Mask Performance - Objective | Performance data recorded from the PAP device comparing leak at baseline compared to with trial mask - Objective | 14 ± 5 days In-Home | 
| Trial Mask Performance - Subjective | Seal leak in comparison to their usual mask. Determine from questionnaires - Subjective | 14 ± 5 days In-Home | 
| Trial Mask Usability | Whether the patient got the correct orientation and positioning of mask without help. Usability interview - Subjective | During Visit Two - 20 minutes | 
| Trial Mask Ease-of-Use | Usability of trial mask compared to usual mask. Determined from questionnaires - Subjective | 14 ± 5 days In-Home | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mask Leak Data | Leak data recorded from PAP device - Objective | 14 ± 5 days In-Home | 
| Seal Size Determination | Did the sizing tool designed for the trial mask correctly predict which size was best suited for the participant. | 1 day-time appointment (1 hour) during Visit Two | 
| Efficacy Data | AHI data recorded from PAP device comparing trial mask use to baseline measurements - Objective | 14 ± 5 days In-Home |