Nasal Pillows vs. Nasal Masks at High CPAP Pressure

Overview

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

Full Title of Study: “Nasal Pillows at High CPAP Pressure”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Crossover Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: December 2012

Interventions

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

Arms, Groups and Cohorts

  • 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]
  • 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]

Clinical Trial Outcome Measures

Primary Measures

  • 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 Measures

  • 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)

Participating in This Clinical Trial

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)

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 90 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • ResMed
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Klaus Schindhelm, Prof, Principal Investigator, ResMed

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