The Evaluation of a Full Face Mask Seal for the Treatment of Obstructive Sleep Apnea

Study Overview
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Brief Summary
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The investigation is a prospective, randomized, single blinded, crossover study. The investigation is designed to evaluate the performance, comfort and ease of use of the F&P Trial Full Face Mask Seal amongst Obstructive Sleep Apnea (OSA) participants. A total number of 40-45 OSA participants will be recruited for the trial by the investigation site

Detailed Description
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This study will involve three visits to the investigation site. During visit one participants will be randomized to, fitted with and issued with the first trial mask seal for use in- home for 7 ±4 days. The participants will then come in to return the mask seal and be fitted and issued with the second trial seal for use in home for 7±4 days. Visit Three will involve the participants returning the second trial seal and providing feedback.

Official Title
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The Evaluation of a Full Face Mask Seal 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 with 'Improved Seal'
* Device: Toffee full face mask with 'Normal Seal'


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 F&P full face 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
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group A<br>Participants will be randomized to receive either the Improved Seal or Normal Seal Toffee full face mask for a total of 7 ± 4 days from visit 1. At visit 2 they will return the first mask and be switched to the remaining mask for a total of 7 ± 4 days from visit 2. | Device: Toffee full face mask with 'Improved Seal'<br>* Participants will be randomized to this arm for a total of 7 ± 4 days from visit 1. Participants will be using the Improved Seal in this treatment arm.<br>Device: Toffee full face mask with 'Normal Seal'<br>* Participants will be randomized to this arm for a total of 7 ± 4 days from visit 1. Participants will be using the Normal Seal in this treatment arm.<br>|
| Experimental: Group B<br>Participants will be randomized to receive either the Improved Seal or Normal Seal Toffee full face mask for a total of 7 ± 4 days from visit 1. At visit 2 they will return the first mask and be switched to the remaining mask for a total of 7 ± 4 days from visit 2. | Device: Toffee full face mask with 'Improved Seal'<br>* Participants will be randomized to this arm for a total of 7 ± 4 days from visit 1. Participants will be using the Improved Seal in this treatment arm.<br>Device: Toffee full face mask with 'Normal Seal'<br>* Participants will be randomized to this arm for a total of 7 ± 4 days from visit 1. Participants will be using the Normal Seal in this treatment arm.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Trial Mask Seal Comfort | Overall seal comfort determined from questionnaires- Subjective | 7 ± 4 days in-home | 
| Trial Mask Seal Acceptability | Preference for trial mask determined from questionnaires at the end of the trial - Subjective | 14 ± 4 days in-home | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Trial Mask Seal Treatment Performance - Objective | Objective Apnea Hypopnea Index (AHI) data recorded from Positive airway pressure (PAP) device, compared to baseline AHI data | 7 ± 4 days in-home | 
| Trial Mask Seal Usability | Usability interview during first visit- Subjective | 1 hour day-time appointment | 
| Trial Mask Seal Treatment Performance- Subjective | Seal performance determined from questionnaires - Subjective | 7 ± 4 days in-home |