Study Results
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View full resultsBasic Information
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COMPLETED
NA
20 participants
INTERVENTIONAL
2011-08-31
2012-12-31
Brief Summary
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1. Whether using nasal pillows at high pressures has comparable outcomes to nasal masks
2. Patient mask type preferences at high pressures
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
NONE
Study Groups
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Nasal Mask First, then Pillows Mask
Nasal mask is used for 7 nights, then followed by Pillows mask for 7 nights.
\[Nasal mask=Mirage Activa, Micro, FX; Pillows mask=Swift FX\]
Nasal mask
Nasal mask (Mirage Activa, Micro, FX)
Pillows mask
Nasal pillows mask (Swift FX)
Pillows Mask, then Nasal Mask
Pillows mask for 7 nights, then followed by Nasal mask is used for 7 nights. \[Nasal mask=MMirage Activa, Micro, FX; Pillows mask=Swift FX\]
Nasal mask
Nasal mask (Mirage Activa, Micro, FX)
Pillows mask
Nasal pillows mask (Swift FX)
Interventions
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Nasal mask
Nasal mask (Mirage Activa, Micro, FX)
Pillows mask
Nasal pillows mask (Swift FX)
Eligibility Criteria
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Inclusion Criteria
* Patients who can read and comprehend English
* Patients being treated for OSA for \>6 months
* Patients ≥ 18 years of age
* Patients using nasal mask systems with fixed pressure ≥ 12 cm H2O
* Patients who can trial the trial masks up to 14 nights
* Patients naive to pillows mask systems
Exclusion Criteria
* Patients using Bilevel flow generators
* Patients who are pregnant
* Patients who have a pre-existing lung disease/ condition that would predispose them to pneumothorax (for example: COPD, lung cancer; fibrosis of the lungs; recent (\< 2years) case of pneumonia or lung infection; lung injury)
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, Prof
Role: PRINCIPAL_INVESTIGATOR
ResMed
Locations
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ResMed
Sydney, New South Wales, Australia
Countries
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References
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Zhu X, Wimms AJ, Benjafield AV. Assessment of the performance of nasal pillows at high CPAP pressures. J Clin Sleep Med. 2013 Sep 15;9(9):873-7. doi: 10.5664/jcsm.2984.
Other Identifiers
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MA000-1442
Identifier Type: -
Identifier Source: org_study_id
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