The Evaluation of an Alternative Sizing Model in Comparison of a Conventional Sizing Model for Full Face Masks in the Treatment of OSA in Terms of Performance and Comfort

Study Overview
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Brief Summary
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The investigation is a prospective non-blinded and semi-randomized clinical investigation. The investigation is designed to assess the alternative sizing model which the trial mask concept is based on and how it compares to a conventional sizing present in the Prototype Full Face Mask (PFFM) mask.

Detailed Description
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The investigation is a prospective non-blinded and semi-randomized investigation. The investigation is designed to assess the alternative sizing model which the trial mask concept is based on and how it compares to a conventional sizing present in the Prototype Full Face Mask (PFFM) mask. A cohort of up to 38 pre-determined current nasal and full face mask users will be recruited by Fisher & Paykel Healthcare in Auckland New Zealand, Waikato DHB in Hamilton New Zealand, Hawkes Bay DHB in Hastings New Zealand and WellSleep Centre in Wellington New Zealand. The study will involve baseline (visit one) gathering the participants' prescribed PAP therapy pressure and their usual mask (to have up-to-date records). The next visit (visit 2) 7 ± 4 days after visit 1, the participants will be fit the Prototype Full Face Mask (PFFM) mask or the alternative sizing based trial mask. At visit 3, which will be after 7 ± 4 days from visit 2, the participants will be crossed over to the mask. At visit 4, 7 ± 4 days after visit 3, all masks and devices will be collected from the participants.

Official Title
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The Evaluation of an Alternative Sizing Model in Comparison of a Conventional Sizing Model for Full-face Masks in the Treatment of OSA in Terms of Performance and Comfort

Conditions
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Sleep Disordered Breathing, Obstructive Sleep Apnea

Intervention / Treatment
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* Device: Alternative sizing model based trial mask
* Device: Prototype Full Face Mask


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult (18+ years of age) Able to give consent Apnea Hypopnea Index (AHI) ≥ 5 on diagnostic night Prescribed a Continuous Positive Airway Pressure (CPAP) device after successful OSA diagnosis Existing nasal or full face mask user. Exclusion Criteria: Inability to give consent Patients who are in a coma or a decreased level of consciousness. Anatomical or physiological conditions making APAP therapy inappropriate (e.g. unconsolidated facial structure) Commercial drivers who are investigated by New Zealand Transport Agency (NZTA) Current diagnosis of CO2 retention Pregnant or may think they are 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
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Alternative sizing model trial mask<br>In this arm participants who are randomized to the alternative sizing model based mask will be given the alternative sizing model based mask to use in home for the duration of this arm. | Device: Alternative sizing model based trial mask<br>* A trial full face mask to be used for this trial for the treatment of obstructive sleep apnea using CPAP therapy.<br>|
| Active Comparator: Prototype Full Face Mask (PFFM)<br>In this arm, participants who are randomized to the PFFM will be given the PFFM to use in-home for the duration of this arm. | Device: Prototype Full Face Mask<br>* A prototype full face mask with previous clinical trial experience used for the treatment of obstructive sleep apnea using CPAP therapy.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Seal Comfort | Obtained from subjective questionnaire | Up to 3 weeks in-home | 
| Subjective Seal Leak | Obtained from subjective questionnaire | Up to 3 weeks in-home | 
| Objective Seal Leak | Measured by device data | Up to 3 weeks in-home | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Objective correct mask selection | Measured by device leak data | Up to 3 weeks in-home | 
| Subjective correct mask selection | Measured by subjective questionnaire | Up to 3 weeks in-home |