<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT02255539</url>
  </required_header>
  <id_info>
    <org_study_id>MA110914</org_study_id>
    <nct_id>NCT02255539</nct_id>
  </id_info>
  <brief_title>Bioburden and Usability Evaluation of a Nasal Prototype CPAP Mask</brief_title>
  <official_title>Bioburden and Usability Study of the Geelong Mask System</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>ResMed</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>ResMed</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      AIM AND HYPOTHESIS: The purpose of this study is to monitor the bioburden and impedance&#xD;
      characteristics of a prototype mask system and to evaluate the usability of the mask system.&#xD;
      The mask system will be assessed according to objective data recordings and user&#xD;
      questionnaires. It is hypothesised that the prototype mask components will not pose a health&#xD;
      risk (with regards to bioburden and impedance) and that the mask system will pass usability&#xD;
      objectives to adequately deliver CPAP treatment.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>January 2015</start_date>
  <completion_date type="Actual">March 2015</completion_date>
  <primary_completion_date type="Actual">March 2015</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Changes from baseline in Bioburden and Impedance of the prototype mask components at 6 weeks</measure>
    <time_frame>6 weeks</time_frame>
    <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.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Usability ratings of the prototype mask using a visual analog scale, compared to a reference level and the participant's current mask</measure>
    <time_frame>6 weeks</time_frame>
    <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.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">42</enrollment>
  <condition>Obstructive Sleep Apnea</condition>
  <arm_group>
    <arm_group_label>CPAP Nasal Mask</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Geelong Prototype Mask</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Geelong Prototype Mask</intervention_name>
    <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.</description>
    <arm_group_label>CPAP Nasal Mask</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Participants willing to give written informed consent&#xD;
&#xD;
          -  Participants who can read and comprehend written and spoken English&#xD;
&#xD;
          -  Participants who are over 18 years of age&#xD;
&#xD;
          -  Participants who have been diagnosed with OSA&#xD;
&#xD;
          -  Participants who have been established on CPAP for ≥ 6 months&#xD;
&#xD;
          -  Participants currently using a ResMed nasal pillows mask&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Participants who are not able to provide written informed consent&#xD;
&#xD;
          -  Participants who are unable to comprehend written and spoken English&#xD;
&#xD;
          -  Participants who are pregnant&#xD;
&#xD;
          -  Participants who are unsuitable to participate in the study in the opinion of the&#xD;
             researcher&#xD;
&#xD;
          -  Participants with a pre-existing lung disease or a condition that would predispose&#xD;
             them to pneumothorax (e.g. COPD, lung cancer; fibrosis of the lungs; recent (&lt; 2years)&#xD;
             case of pneumonia or lung infection, lung injury)&#xD;
&#xD;
          -  Participants who cannot participate for the duration of the trial&#xD;
&#xD;
          -  Participants who are established on bi-level support therapy&#xD;
&#xD;
          -  Participants who are not established on a ResMed nasal pillows mask&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>90 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Klaus Schindhelm, BE PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Graduate School of Biomedical Engineering, University of New South Wales, Sydney Australia and Applied Research, ResMed Ltd Sydney Australia</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>ResMed Ltd</name>
      <address>
        <city>Sydney</city>
        <state>New South Wales</state>
        <zip>2153</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Australia</country>
  </location_countries>
  <verification_date>January 2021</verification_date>
  <study_first_submitted>September 24, 2014</study_first_submitted>
  <study_first_submitted_qc>September 29, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 2, 2014</study_first_posted>
  <last_update_submitted>January 27, 2021</last_update_submitted>
  <last_update_submitted_qc>January 27, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">February 1, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>sleep</keyword>
  <keyword>sleep apnea</keyword>
  <keyword>OSA</keyword>
  <keyword>CPAP</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Sleep Apnea Syndromes</mesh_term>
    <mesh_term>Sleep Apnea, Obstructive</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02255539
org study id: MA110914
nct id: NCT02255539
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
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.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Supportive Care
masking: None (Open Label)
measure: Changes from baseline in Bioburden and Impedance of the prototype mask components at 6 weeks
time frame: 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.
measure: Usability ratings of the prototype mask using a visual analog scale, compared to a reference level and the participant's current mask
time frame: 6 weeks
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.
arm group label: CPAP Nasal Mask
arm group type: Experimental
description: Geelong Prototype Mask
intervention type: Device
intervention name: Geelong Prototype Mask
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.
arm group label: CPAP Nasal Mask
criteria: 
gender: All
minimum age: 18 Years
maximum age: 90 Years
healthy volunteers: No
last name: Klaus Schindhelm, BE PhD
role: Principal Investigator
affiliation: Graduate School of Biomedical Engineering, University of New South Wales, Sydney Australia and Applied Research, ResMed Ltd Sydney Australia
facility: 
country: Australia
responsible party type: Sponsor
mesh term: Sleep Apnea Syndromes
mesh term: Sleep Apnea, Obstructive