Bioburden and Usability Evaluation of a Nasal Prototype CPAP Mask

Not Applicable

Completed

• Conditions: Obstructive Sleep Apnea
• Interventions: Device: Geelong Prototype Mask

• Registration Number: NCT02255539
• Lead Sponsor: ResMed

Brief Summary

AIM AND HYPOTHESIS: The purpose of this study is to monitor the bioburden and impedance characteristics of a prototype mask system and to evaluate the usability of the mask system. The mask system will be assessed according to objective data recordings and user questionnaires. It is hypothesised that the prototype mask components will not pose a health risk (with regards to bioburden and impedance) and that the mask system will pass usability objectives to adequately deliver CPAP treatment.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-09-24
• Study First Submitted QC: 2014-09-29
• Study First Posted: 2014-10-02
• Study Start: 2015-01
• Primary Completion: 2015-03
• Study Completion: 2015-03
• Status Verified: 2021-01
• Last Update Submitted: 2021-01-27
• Last Update Posted: 2021-02-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 42

Inclusion Criteria

• Participants willing to give written informed consent
• Participants who can read and comprehend written and spoken English
• Participants who are over 18 years of age
• Participants who have been diagnosed with OSA
• Participants who have been established on CPAP for ≥ 6 months
• Participants currently using a ResMed nasal pillows mask

Exclusion Criteria

• Participants who are not able to provide written informed consent
• Participants who are unable to comprehend written and spoken English
• Participants who are pregnant
• Participants who are unsuitable to participate in the study in the opinion of the researcher
• Participants with a pre-existing lung disease or a condition that would predispose them to pneumothorax (e.g. COPD, lung cancer; fibrosis of the lungs; recent (< 2years) case of pneumonia or lung infection, lung injury)
• Participants who cannot participate for the duration of the trial
• Participants who are established on bi-level support therapy
• Participants who are not established on a ResMed nasal pillows mask

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
CPAP Nasal Mask	Geelong Prototype Mask	Geelong Prototype Mask

Primary Outcome Measures

Name	Time	Method
Changes from baseline in Bioburden and Impedance of the prototype mask components at 6 weeks	6 weeks	The population of microorganisms on mask components will be measured after 6 weeks of continuous use by a participant on their PAP therapy device to assess the safe replacement interval of the component. The impedance of the mask will also be measured to assess whether the build up of microorganisms on the mask component will affect the usability and effectiveness of the mask. Bioburden and impedance testing will be conducted in a lab environment on return of the prototype mask and components.

Secondary Outcome Measures

Name	Time	Method
Usability ratings of the prototype mask using a visual analog scale, compared to a reference level and the participant's current mask	6 weeks	Participants will be asked to complete a short questionnaire at the end of each week to evaluate the general usability of the mask system. The questionnaire will include questions related to mask comfort. The participants will answer the questions using an 11-point Likert scale.

Trial Locations

Locations (1)

ResMed Ltd; 🇦🇺 Sydney, New South Wales, Australia