Usability Evaluation of Menai CPAP Masks

ResMed30 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

NONE

Enrollment

Conditions

Obstructive Sleep Apnea

Interventions

Menai mask (full face)DEVICE

Prototype mask system (full face variant) with novel vent and humidification system

Menai Standard mask (full face)DEVICE

Prototype mask system (full face variant) with conventional vent and humidification system

Menai mask (nasal)DEVICE

Prototype mask system (nasal variant) with novel vent and humidification system

Eligibility

Sex: ALLMin age: 18 YearsMax age: 90 Years

Medical Language ↔ Plain English

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

Locations (1)

ResMed Sleep Research Centre

Sydney, New South Wales, Australia

Outcomes

Primary Outcomes

Usability Performance Evaluation

Evaluation of the usability performance (seal, comfort, etc) of the Menai masks, compared to the Comparison Menai Standard masks.

Time frame: 2 weeks

Secondary Outcomes

Humidification Performance Evaluation

Evaluation of the humidification performance of the Menai masks (passive humidification), compared to the Comparison Menai Standard masks (active humidification).

Time frame: 2 weeks

Data from ClinicalTrials.gov

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