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

NCT00773721 | Completed

• 1 other identifier: MA131008
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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

Conditions

Obstructive Sleep Apnea (OSA)

Outcome Measures

Primary Outcomes (1)

• Measurement of bacterial accumulation in the new material.

  up to 35 days (5 weeks).

Study Arms (1)

1

EXPERIMENTAL

Volunteers who are currently using CPAP treatment will trial a new mask system for up to five weeks

Device: CPAP mask

Interventions

CPAP mask DEVICE

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.

1

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients who are 18+
• Patients willing to give written informed consent
• Patients who can read and comprehend English
• Patients being treated for OSA with CPAP for \>6 months
• Patients using ResMed Masks

You may not qualify if:

• Known to have any pre-existing dermatological condition
• Has been treated with antibiotics in the previous month
• Any condition which, in the opinion of the investigator, would make the subject unsuitable or unsafe for enrolment, or could interfere with the subject participating in and completing the protocol.
• Patients currently using ResMed masks: Swift, Activa, or Liberty.

Sponsors & Collaborators

• ResMed: lead

Study Sites (1)

Resmed Centre for Healthy Sleep

Sydney, New South Wales, 2153, Australia

Location

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Condition Hierarchy (Ancestors)

Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Study Officials

• Klaus Schindhelm, PhD

  ResMed/ The University of New South Wales

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 15, 2008
• First Posted: October 16, 2008
• Study Start: October 1, 2008
• Primary Completion: December 1, 2008
• Study Completion: May 1, 2009
• Last Updated: February 4, 2021

Record last verified: 2021-02

Locations

AU (1)