Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
30 participants
INTERVENTIONAL
2015-05-31
2015-07-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
CROSSOVER
SUPPORTIVE_CARE
NONE
Study Groups
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Full Face
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.
Menai mask (full face)
Prototype mask system (full face variant) with novel vent and humidification system
Menai Standard mask (full face)
Prototype mask system (full face variant) with conventional vent and humidification system
Nasal
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.
Menai mask (nasal)
Prototype mask system (nasal variant) with novel vent and humidification system
Menai Standard mask (nasal)
Prototype mask system (nasal variant) with conventional vent and humidification system
Pillows
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.
Menai mask (pillows)
Prototype mask system (pillows variant) with conventional vent and humidification system
Menai Standard mask (pillows)
Prototype mask system (pillows variant) with conventional vent and humidification system
Interventions
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Menai mask (full face)
Prototype mask system (full face variant) with novel vent and humidification system
Menai Standard mask (full face)
Prototype mask system (full face variant) with conventional vent and humidification system
Menai mask (nasal)
Prototype mask system (nasal variant) with novel vent and humidification system
Menai Standard mask (nasal)
Prototype mask system (nasal variant) with conventional vent and humidification system
Menai mask (pillows)
Prototype mask system (pillows variant) with conventional vent and humidification system
Menai Standard mask (pillows)
Prototype mask system (pillows variant) with conventional vent and humidification system
Eligibility Criteria
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Inclusion Criteria
* 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 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
18 Years
90 Years
ALL
No
Sponsors
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ResMed
INDUSTRY
Responsible Party
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Principal Investigators
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Klaus Schindhelm, BE PhD
Role: PRINCIPAL_INVESTIGATOR
Graduate School of Biomedical Engineering, University of New South Wales, Sydney Australia and Applied Research, ResMed Ltd Sydney Australia
Locations
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ResMed Sleep Research Centre
Sydney, New South Wales, Australia
Countries
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Other Identifiers
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MA220115
Identifier Type: -
Identifier Source: org_study_id
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