A Development Study to Evaluate a Nasal 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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The investigation is a prospective, non-randomized, non-blinded study. Up to 45 OSA patients who currently use a nasal or nasal pillows mask will be recruited This study will involve a baseline (Visit One) data gathering with the participant's PAP therapy and their usual mask. This will be followed by the participants being fitted with the trial nasal mask for use in-home (Visit Two). The participant then will come in to return the mask (Visit Three) and give 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 loan 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 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 Nasal 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 Saturn


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: AHI ≥ 5 from diagnostic PSG night Aged 22 and over (FDA defined as adult) Either prescribed APAP, CPAP or Bi-Level PAP for OSA Existing nasal or nasal pillows mask users (preferable 70%:30% split) Fluent in spoken and written English Exclusion Criteria: Inability to give informed consent Patient intolerant to CPAP therapy 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: 18 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 Saturn<br>Participants will be placed on this arm for a total of 14 ± 5 days from Visit 2. Participants will be using the trial nasal mask during this treatment arm. | Device: F&P Saturn<br>* Participants will be placed on this arm for a total of 14 ± 5 days from Visit 2. Participants will be using the trial nasal mask during this treatment arm.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants Reporting Comfort Compared to Their Usual Mask. | Comfort reported from participants questionnaires to evaluate the use of the F&P nasal mask for treatment of Obstructive Sleep Apnea | 14 ± 5 days In-Home | 
| Number of Participants PAP Device Performance Reporting | Determined from data recorded from the PAP device to evaluate the use of the F&P nasal mask for treatment of Obstructive Sleep Apnea | 14 ± 5 days In-Home | 
| Number of Participants Subjective Performance Rating of the Nasal Mask | Performance reported from participants questionnaires to evaluate the use of the F&P nasal mask for treatment of Obstructive Sleep Apnea | 14 ± 5 days In-Home | 
| Number of Participants Subjective Reporting of Nasal Mask Usability | Usability reported from participants questionnaires to evaluate the use of the F&P nasal mask for treatment of Obstructive Sleep Apnea | During Visit Two - 20 minutes | 
| Number of Participants Subjective Recording of Ease of Nasal Mask Use. | Ease of use reported from participants questionnaires to evaluate the use of the F&P nasal mask for treatment of Obstructive Sleep Apnea | 14 ± 5 days In-Home | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants Leak Compared to Usual Mask | Leak data recorded from PAP device to evaluate the use of the F&P nasal mask for treatment of Obstructive Sleep Apnea | 14 ± 5 days In-Home | 
| Number of Participants With Correct Nasal Mask Size Determination | Sizing determined from a customized fitting tool to evaluate the use of the F&P nasal mask for treatment of Obstructive Sleep Apnea | 1 day-time appointment (1 hour) |