Nasal Pillows vs. Nasal Masks at High CPAP Pressure

Nasal Pillows at High CPAP Pressure

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

Study Overview

• Status: Completed
• Conditions: OSA
• Intervention / Treatment: Device: Nasal mask; Device: Pillows mask

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Australia
  • New South Wales
    • Sydney, New South Wales, Australia, 2153
      • ResMed

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
AHI on Nasal Mask and Pillows Mask	AHI (measure of sleep-disordered breathing severity) on nasal mask and nasal pillows measured as average events/hour	7 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Usability	Participant's feedback of performance of the study devices. Likert Scale 0-10 (0=very bad, 10=very good)	After 7 days of use

Collaborators and Investigators

• Sponsor: ResMed
• Investigators: Principal Investigator: Klaus Schindhelm, Prof, ResMed

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: August 1, 2011
• Primary Completion (Actual): December 1, 2012
• Study Completion (Actual): December 1, 2012

Study Registration Dates

• First Submitted: September 16, 2012
• First Submitted That Met QC Criteria: September 19, 2012
• First Posted (Estimate): September 24, 2012

Study Record Updates

• Last Update Posted (Estimate): October 8, 2014
• Last Update Submitted That Met QC Criteria: October 7, 2014
• Last Verified: September 1, 2014

More Information

Terms related to this study

• Other Study ID Numbers: MA000-1442