Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Nasal Pillows vs. Nasal Masks at High CPAP Pressure

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
ResMed
ClinicalTrials.gov Identifier:
NCT01690923
First received: September 16, 2012
Last updated: October 7, 2014
Last verified: September 2014
  Purpose

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 Intervention
OSA
Device: Nasal mask
Device: Pillows mask

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Nasal Pillows at High CPAP Pressure

Further study details as provided by ResMed:

Primary Outcome Measures:
  • AHI on Nasal Mask and Pillows Mask [ Time Frame: 7 days ] [ Designated as safety issue: No ]
    AHI (measure of sleep-disordered breathing severity) on nasal mask and nasal pillows measured as average events/hour


Secondary Outcome Measures:
  • Usability [ Time Frame: After 7 days of use ] [ Designated as safety issue: No ]
    Participant's feedback of performance of the study devices. Likert Scale 0-10 (0=very bad, 10=very good)


Enrollment: 20
Study Start Date: August 2011
Study Completion Date: December 2012
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01690923

Locations
Australia, New South Wales
ResMed
Sydney, New South Wales, Australia, 2153
Sponsors and Collaborators
ResMed
Investigators
Principal Investigator: Klaus Schindhelm, Prof ResMed
  More Information

No publications provided by ResMed

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: ResMed
ClinicalTrials.gov Identifier: NCT01690923     History of Changes
Other Study ID Numbers: MA000-1442
Study First Received: September 16, 2012
Results First Received: September 26, 2014
Last Updated: October 7, 2014
Health Authority: Australia: Human Research Ethics Committee

ClinicalTrials.gov processed this record on November 20, 2014