The Evaluation of a 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 with the F&P trial full face and nasal mask amongst Obstructive Sleep Apnea (OSA) patients. Up to 70 OSA patients will be recruited from the North Texas Lung and Sleep Clinic (NTLSC) database

Detailed Description
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Visit 1 will involve the participants being fitted with the F&P trial full face or nasal mask for use in-home. The participant will then come in to return the mask (Visit Two) and have a final interview, this ensures the maximum time participants will be exposed to the trial mask in home will be 14 ± 4 days from visit one. 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 three weeks of the beginning of the study.

Official Title
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The Evaluation of a Full Face and 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 Seal Improvement Project


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 oronasal and nasal 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: F&P Seal Improvement Project<br>participants will be placed on this arm for a total of 14 +- 4 days from visit 1. participants will be using the trial mask during this treatment arm | Device: F&P Seal Improvement Project<br>* Participants will be placed on this arm for a total 14 ± 4 days from Visit 1. Participants will be using the trial full face or 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 Subjective Usability Reporting | Usability reported from participants questionnaires to evaluate the use of the F&P mask for treatment of Obstructive Sleep Apnea | 14 ± 4 days in-Home | 
| Number or Participants Comparative Subjective Reported Comfort | Comfort reported from participants questionnaires to evaluate the use of the F&P mask for treatment of Obstructive Sleep Apnea compared to usual | 14 ± 4 days in-Home | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Objective Performance Reporting | Objective Apnea-Hypopnea Index (AHI) data recorded from the positive airway pressure (PAP) device to evaluate the use of the F&P mask for treatment of Obstructive Sleep Apnea | 14 ± 4 days in-Home | 
| Number of Participants Reported Mask Acceptability | Acceptability reported from participants questionnaires to evaluate the use of the F&P mask for treatment of Obstructive Sleep Apnea | 14 ± 4 days in-Home | 
| Number of Participants Subjective Comfort Reporting | Comfort reported from participants questionnaires to evaluate the use of the F&P mask for treatment of Obstructive Sleep Apnea | 14 ± 4 days in-Home | 
| Number or Participants Subjective Reporting of Seal Performance | Seal performance reported from participants questionnaires to evaluate the use of the F&P mask for treatment of Obstructive Sleep Apnea | 14 ± 4 days in-Home |