Obstructive Sleep Apnea
Conditions
Keywords
sleep, apnea, OSA, CPAP
Brief summary
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
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.
Interventions
DEVICEMenai mask (full face)
Prototype mask system (full face variant) with novel vent and humidification system
DEVICEMenai Standard mask (full face)
Prototype mask system (full face variant) with conventional vent and humidification system
DEVICEMenai mask (nasal)
Prototype mask system (nasal variant) with novel vent and humidification system
DEVICEMenai Standard mask (nasal)
Prototype mask system (nasal variant) with conventional vent and humidification system
DEVICEMenai mask (pillows)
Prototype mask system (pillows variant) with conventional vent and humidification system
DEVICEMenai Standard mask (pillows)
Prototype mask system (pillows variant) with conventional vent and humidification system
Sponsors
ResMed
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Usability Performance Evaluation | 2 weeks | Evaluation of the usability performance (seal, comfort, etc) of the Menai masks, compared to the Comparison Menai Standard masks. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Humidification Performance Evaluation | 2 weeks | Evaluation of the humidification performance of the Menai masks (passive humidification), compared to the Comparison Menai Standard masks (active humidification). |
Countries
Australia
Outcome results
None listed