Usability Evaluation of Menai CPAP Masks

Study Overview
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Brief Summary
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The primary objective of this study is to evaluate the subjective performance of the Menai mask systems (full face, nasal, and pillows variants), compared against Comparison mask systems.

Detailed Description
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The study will evaluate the subjective seal, comfort, stability, usability, and humidification performance of the prototype mask systems in CPAP established patients. The performance of the prototype Menai mask systems (full face, nasal, and pillows variants) will be subjectively assessed through user questionnaires based on an 11-point Likert scale, and will be compared against Comparison masks. The prototype masks share the same parts (cushion, frame, headgear), with the difference being that the Menai masks feature a novel vent and humidification system.

Official Title
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Menai Mask Systems - Clinical Study 1

Conditions
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Obstructive Sleep Apnea

Intervention / Treatment
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* Device: Menai mask (full face)
* Device: Menai Standard mask (full face)
* Device: Menai mask (nasal)
* Device: Menai Standard mask (nasal)
* Device: Menai mask (pillows)
* Device: Menai Standard mask (pillows)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Participants willing to provide written informed consent Participants who can read and comprehend written and spoken English Participants who are over 18 years of age Participants who have been diagnosed with OSA Participants who have been established on CPAP for ≥ 6 months Participants who are currently using the same mask type/variant as the interventional mask system to be evaluated Exclusion Criteria: Participants who are not able to provide written informed consent Participants who are unable to comprehend written and spoken English Participants who are pregnant Participants who are unsuitable to participate in the study in the opinion of the researcher Participants with a pre-existing lung disease or a condition that would predispose them to pneumothorax (e.g. COPD, lung cancer; fibrosis of the lungs; recent (< 2years) case of pneumonia or lung infection, lung injury) Participants who cannot participate for the duration of the trial Participants who are established on bi-level support therapy Participants who are not currently using the same mask type/variant as the interventional mask system to be evaluated

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 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: Supportive Care
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Full Face<br>Participants will trial the same mask type/variant (full face, nasal, pillows) as the variant they are using as part of their current treatment. Participants in this arm will trial the Menai mask (full face) and Comparison Menai Standard mask (full face) for 7 nights each. | Device: Menai mask (full face)<br>* Prototype mask system (full face variant) with novel vent and humidification system<br>Device: Menai Standard mask (full face)<br>* Prototype mask system (full face variant) with conventional vent and humidification system<br>|
| Experimental: Nasal<br>Participants will trial the same mask type/variant (full face, nasal, pillows) as the variant they are using as part of their current treatment. Participants in this arm will trial the Menai mask (nasal) and Comparison Menai Standard mask (nasal) for 7 nights each. | Device: Menai mask (nasal)<br>* Prototype mask system (nasal variant) with novel vent and humidification system<br>Device: Menai Standard mask (nasal)<br>* Prototype mask system (nasal variant) with conventional vent and humidification system<br>|
| Experimental: Pillows<br>Participants will trial the same mask type/variant (full face, nasal, pillows) as the variant they are using as part of their current treatment. Participants in this arm will trial the Menai mask (pillows) and Comparison Menai Standard mask (pillows) for 7 nights each. | Device: Menai mask (pillows)<br>* Prototype mask system (pillows variant) with conventional vent and humidification system<br>Device: Menai Standard mask (pillows)<br>* Prototype mask system (pillows variant) with conventional vent and humidification system<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Usability Performance Evaluation | Evaluation of the usability performance (seal, comfort, etc) of the Menai masks, compared to the Comparison Menai Standard masks. | 2 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Humidification Performance Evaluation | Evaluation of the humidification performance of the Menai masks (passive humidification), compared to the Comparison Menai Standard masks (active humidification). | 2 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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sleep, apnea, OSA, CPAP