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Bioburden and Usability Evaluation of a Nasal Prototype CPAP Mask

Primary Purpose

Obstructive Sleep Apnea

Status
Completed
Phase
Not Applicable
Locations
Australia
Study Type
Interventional
Intervention
Geelong Prototype Mask
Sponsored by
ResMed
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Obstructive Sleep Apnea focused on measuring sleep, sleep apnea, OSA, CPAP

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • ResMed Ltd

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

CPAP Nasal Mask

Arm Description

Geelong Prototype Mask

Outcomes

Primary Outcome Measures

Changes from baseline in Bioburden and Impedance of the prototype mask components at 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

Usability ratings of the prototype mask using a visual analog scale, compared to a reference level and the participant's current mask
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.

Full Information

First Posted
September 24, 2014
Last Updated
January 27, 2021
Sponsor
ResMed
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1. Study Identification

Unique Protocol Identification Number
NCT02255539
Brief Title
Bioburden and Usability Evaluation of a Nasal Prototype CPAP Mask
Official Title
Bioburden and Usability Study of the Geelong Mask System
Study Type
Interventional

2. Study Status

Record Verification Date
January 2021
Overall Recruitment Status
Completed
Study Start Date
January 2015 (undefined)
Primary Completion Date
March 2015 (Actual)
Study Completion Date
March 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
ResMed

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obstructive Sleep Apnea
Keywords
sleep, sleep apnea, OSA, CPAP

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
42 (Actual)

8. Arms, Groups, and Interventions

Arm Title
CPAP Nasal Mask
Arm Type
Experimental
Arm Description
Geelong Prototype Mask
Intervention Type
Device
Intervention Name(s)
Geelong Prototype Mask
Intervention Description
A nasal pillows prototype mask to be trialled with a PAP therapy device for a period of 6 weeks. Participants will wear the mask in place of their current mask for the duration of the trial.
Primary Outcome Measure Information:
Title
Changes from baseline in Bioburden and Impedance of the prototype mask components at 6 weeks
Description
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.
Time Frame
6 weeks
Secondary Outcome Measure Information:
Title
Usability ratings of the prototype mask using a visual analog scale, compared to a reference level and the participant's current mask
Description
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.
Time Frame
6 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Klaus Schindhelm, BE PhD
Organizational Affiliation
Graduate School of Biomedical Engineering, University of New South Wales, Sydney Australia and Applied Research, ResMed Ltd Sydney Australia
Official's Role
Principal Investigator
Facility Information:
Facility Name
ResMed Ltd
City
Sydney
State/Province
New South Wales
ZIP/Postal Code
2153
Country
Australia

12. IPD Sharing Statement

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Bioburden and Usability Evaluation of a Nasal Prototype CPAP Mask

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