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Nasal Pillows vs. Nasal Masks at High CPAP Pressure

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01690923
Recruitment Status : Completed
First Posted : September 24, 2012
Results First Posted : October 8, 2014
Last Update Posted : October 8, 2014
Sponsor:
Information provided by (Responsible Party):
ResMed

Study Description
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Brief Summary:

The aim of this evaluation is to test:

  1. Whether using nasal pillows at high pressures has comparable outcomes to nasal masks
  2. Patient mask type preferences at high pressures

Condition or disease Intervention/treatment Phase
OSA Device: Nasal mask Device: Pillows mask Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Nasal Pillows at High CPAP Pressure
Study Start Date : August 2011
Actual Primary Completion Date : December 2012
Actual Study Completion Date : December 2012
Arms and Interventions
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Arm Intervention/treatment
Experimental: 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]

 Device: Nasal mask
Nasal mask (Mirage Activa, Micro, FX)

Device: Pillows mask
Nasal pillows mask (Swift FX)
Experimental: 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]
 Device: Nasal mask
Nasal mask (Mirage Activa, Micro, FX)

Device: Pillows mask
Nasal pillows mask (Swift FX)


Outcome Measures
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Primary Outcome Measures :
  1. AHI on Nasal Mask and Pillows Mask [ Time Frame: 7 days ]
    AHI (measure of sleep-disordered breathing severity) on nasal mask and nasal pillows measured as average events/hour


Secondary Outcome Measures :
  1. Usability [ Time Frame: After 7 days of use ]
    Participant's feedback of performance of the study devices. Likert Scale 0-10 (0=very bad, 10=very good)


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients willing to give written informed consent
  • 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 an inappropriate mask system
  • 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)
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01690923


Locations
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Australia, New South Wales
ResMed
Sydney, New South Wales, Australia, 2153
Sponsors and Collaborators
ResMed
Investigators
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Principal Investigator: Klaus Schindhelm, Prof ResMed
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: ResMed
ClinicalTrials.gov Identifier: NCT01690923    
Other Study ID Numbers: MA000-1442
First Posted: September 24, 2012    Key Record Dates
Results First Posted: October 8, 2014
Last Update Posted: October 8, 2014
Last Verified: September 2014