Comparison of Two Continuous Positive Airway Pressure Systems

Study Overview
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Brief Summary
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Randomised crossover trial of a novel and traditional Continuous Positive Airway Pressure (CPAP) system in Obstructive Sleep Apnoea patients.

Official Title
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Comparison of the Subjective and Objective Performance of a Novel Continuous Positive Airway Pressure (CPAP) System With a Traditional Continuous Positive Airway Pressure (CPAP) System.

Conditions
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Obstructive Sleep Apnoea

Intervention / Treatment
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* Device: Novel System
* Device: Traditional System


Participation Criteria
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Eligibility Criteria
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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

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 |
| --- | --- |
| Active Comparator: Arm 1<br>Participants randomised to Arm 1 will receive an intervention of 7 nights with the Novel system followed by 7 nights with theTraditional system | Device: Novel System<br>* A Novel full Continuous Positive Airway Pressure (CPAP) system - Prototype Device, Mask + Accessories<br>Device: Traditional System<br>* A Traditional full Continuous Positive Airway Pressure (CPAP) system- Released Device + Accessories, Prototype Mask<br>* Other names: AirSense System;|
| Active Comparator: Arm 2<br>Participants randomised to Arm 1 will receive an intervention of 7 nights with the Traditional system followed by 7 nights with the Novel system | Device: Novel System<br>* A Novel full Continuous Positive Airway Pressure (CPAP) system - Prototype Device, Mask + Accessories<br>Device: Traditional System<br>* A Traditional full Continuous Positive Airway Pressure (CPAP) system- Released Device + Accessories, Prototype Mask<br>* Other names: AirSense System;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Subjective usability ratings of the prototype system using a visual analogue scale, compared to a reference level and the second full system. | 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. | 1 year |