MedTrace Logo

Foam Mask - Assessment of Bioburden in a New Mask Seal Material

NCT00773721 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2021-02-04

No results posted yet for this study

Summary

Obstructive sleep apnoea (OSA) is characterised by a partial or complete collapse of the upper airway during sleep. The treatment of choice for OSA is Continuous Positive Airway Pressure (CPAP). CPAP acts as a positive airway splint, delivering a fixed positive airway pressure to the upper airway via a tube and mask. Compliance, however, to therapy requires that the mask is suitably comfortable so as not to disturb sleep.

A key contributor to comfort is the seal component of the mask system. Current mask seals are mainly silicone elastomers, which though well understood and accepted, are often uncomfortable. It is proposed to replace the solid elastomer with a soft polymer foam.

The foam is highly porous, and has open cells at its surface. It is therefore more likely to accumulate biological material with repeated use. The current (silicone) material does not present any problematic bioburden issues. Therefore it is important to investigate whether the foam will present bioburden problems to patients, within specified usage parameters.

The aims of this study therefore are:

1. to observe the rate of bacterial accumulation on foam mask seal material (polyether polyurethane,)
2. to determine the replacement interval for a foam mask seal, and
3. assess the comfort and function of a foam mask seal.

Conditions

  • Obstructive Sleep Apnea (OSA)

Interventions

DEVICE

CPAP mask

Current CPAP masks are mainly silicone elastomers, which though well understood and accepted, are often uncomfortable. Test Units: The test unit is a foam seal component which directly replaces the patients existing silicone mask cushion, and is fitted to the patients existing mask frame. Subjects will wear the test unit mask, instead of their current CPAP mask, each night whilst sleeping.

Sponsors & Collaborators

  • ResMed

    lead INDUSTRY

Principal Investigators

  • Klaus Schindhelm, PhD · ResMed/ The University of New South Wales

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-10-31
Primary Completion
2008-12-31
Completion
2009-05-31

Countries

  • Australia

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00773721 on ClinicalTrials.gov