Nasal Pillows vs. Nasal Masks at High CPAP Pressure

OSA Clinical Trial

Official title:

Nasal Pillows at High CPAP Pressure

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01690923
• Other study ID #: MA000-1442
• Status: Completed
• Phase: N/A
• First received: September 16, 2012
• Last updated: October 7, 2014
• Start date: August 2011
• Est. completion date: December 2012

Study information

• Verified date: September 2014
• Source: ResMed
• Contact: n/a
• Is FDA regulated: No
• Health authority: Australia: Human Research Ethics Committee
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: December 2012
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• OSA

Intervention

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

Locations

Country	Name	City	State
Australia	ResMed	Sydney	New South Wales

Sponsors (1)

Lead Sponsor	Collaborator
ResMed

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No