Nasal Pillows vs. Nasal Masks at High CPAP Pressure

Not Applicable

Completed

• Conditions: OSA
• Interventions: Device: Nasal mask; Device: Pillows mask

• Registration Number: NCT01690923
• Lead Sponsor: ResMed

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

Detailed Description

Not available

Study Timeline

• Study Start: 2011-08
• Study First Submitted: 2012-09-16
• Study First Submitted QC: 2012-09-19
• Study First Posted: 2012-09-24
• Primary Completion: 2012-12
• Study Completion: 2012-12
• Status Verified: 2014-09
• Results First Submitted: 2014-09-26
• Results First Submitted QC: 2014-10-07
• Last Update Submitted: 2014-10-07
• Results First Posted: 2014-10-08
• Last Update Posted: 2014-10-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Nasal Mask First, then Pillows Mask	Pillows mask	Nasal mask is used for 7 nights, then followed by Pillows mask for 7 nights. \[Nasal mask=Mirage Activa, Micro, FX; Pillows mask=Swift FX\]
Pillows Mask, then Nasal Mask	Nasal mask	Pillows mask for 7 nights, then followed by Nasal mask is used for 7 nights. \[Nasal mask=MMirage Activa, Micro, FX; Pillows mask=Swift FX\]
Pillows Mask, then Nasal Mask	Pillows mask	Pillows mask for 7 nights, then followed by Nasal mask is used for 7 nights. \[Nasal mask=MMirage Activa, Micro, FX; Pillows mask=Swift FX\]
Nasal Mask First, then Pillows Mask	Nasal mask	Nasal mask is used for 7 nights, then followed by Pillows mask for 7 nights. \[Nasal mask=Mirage Activa, Micro, FX; Pillows mask=Swift FX\]

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

ResMed; 🇦🇺 Sydney, New South Wales, Australia