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OpenTrials
Completed

NCT Number: NCT01690923

Nasal Pillows vs. Nasal Masks 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

Completed

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Key information

Conditions

OSA

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

ResMed

Sydney, New South Wales, 2153, Australia

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

NASAL MASK

Device

Nasal mask (Mirage Activa, Micro, FX)

Pillows mask

Device

Nasal pillows mask (Swift FX)

Primary outcomes

  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 outcomes

  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)

Sponsors and collaborators

Lead sponsor

ResMed

Industry

Registry information

Official study title

Nasal Pillows at High CPAP Pressure

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Sep 24, 2012
Registry last updated
Oct 8, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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