Obstructive Sleep Apnoea
Conditions
Brief summary
Randomised crossover trial of a novel and traditional Continuous Positive Airway Pressure (CPAP) system in Obstructive Sleep Apnoea patients.
Interventions
DEVICENovel System
A Novel full Continuous Positive Airway Pressure (CPAP) system - Prototype Device, Mask + Accessories
DEVICETraditional System
A Traditional full Continuous Positive Airway Pressure (CPAP) system- Released Device + Accessories, Prototype Mask
Sponsors
ResMed
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Participant is willing to provide written informed consent * Participant is able to read and comprehend written and spoken English * Participant is ≥ 18 years of age * Participant has been diagnosed with Obstructive Sleep Apnoea (OSA) * Participants has been established on Continuous Positive Airway Pressure (CPAP) for ≥ 6 months * Participants is currently using the same mask type/variant as the interventional mask system to be evaluated * Participants is able to participate for the duration of the study
Exclusion criteria
* Participant is not willing to provide written informed consent * Participant is unable to read and comprehend written and spoken English * Participant is \< 18 years of age * Participant has not been diagnosed with Obstructive Sleep Apnoea (OSA) * Participant has not been established on Continuous Positive Airway Pressure (CPAP) for ≥ 6 months * Participant is not currently using the same mask type/variant as the interventional mask system to be evaluated * Participant is unable to participate for the duration of the study * Participant is pregnant * Participant is established on bi-level support therapy * Participant, or participants bed partner, has metallic implants in head neck or chest * Participant has a with a pre-existing lung disease or a condition that would predispose them to pneumothorax (e.g. Chronic Obstructive Pulmonary Disease (COPD), lung cancer; fibrosis of the lungs; recent (\< 2years) case of pneumonia or lung infection, lung injury) * Participant is unsuitable to participate in the study in the opinion of the researcher
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Subjective usability ratings of the prototype system using a visual analogue scale, compared to a reference level and the second full system. | 1 year | Participants will be asked to complete a short questionnaire at the end of each week to evaluate the general usability of the system. The questionnaire will include questions related to system use and comfort. The participants will answer the questions using an 11-point Likert scale. |
Countries
Australia
Outcome results
None listed