xml: <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/NCT06036329</url>
    </required_header>
    <id_info>
      <org_study_id>SLP-23-02-01</org_study_id>
      <secondary_id>D638-1118</secondary_id>
      <nct_id>NCT06036329</nct_id>
    </id_info>
    <brief_title>Whitsundays (Nasal) Mask Take Home Study (90 Days)</brief_title>
    <official_title>Evaluating the Usability and Performance of a PAP Mask System in the Home Environment</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>ResMed</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>ResMed</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>Yes</is_fda_regulated_device>
      <is_unapproved_device>Yes</is_unapproved_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        The goal of this multi-site, prospective, randomized, double arm study without blinding is to&#xD;
        test the usability of the Whitsundays mask system at home by patients with Obstructive Sleep&#xD;
        Apnea. The main questions it aims to answer are:&#xD;
  &#xD;
          -  How the Whitsundays masks performs in the home environment&#xD;
  &#xD;
          -  What is the subject's first impression of the Whitsundays mask and what is their&#xD;
             preference compared to their own mask&#xD;
  &#xD;
          -  What is the difference between the subject's objective therapy data when using the&#xD;
             Whitsundays mask compared to their own mask&#xD;
  &#xD;
          -  Is there wear and tear of the Whitsundays mask and how frequently do the cushions need&#xD;
             replacement Participants will be asked to use the Whitsundays mask for 90 days, answer&#xD;
             questionnaires about the initial impression of the mask, the performance of the mask,&#xD;
             and their preference compared to their own mask. Researchers will compare one group of&#xD;
             subjects who will be provided with cushion replacements to another group who will only&#xD;
             be provided with cushion replacements upon request to determine the need for cushion&#xD;
             replacement, its frequency, and the reasons for cushion replacement during home usage.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Enrolling by invitation</overall_status>
    <start_date type="Actual">May 31, 2023</start_date>
    <completion_date type="Anticipated">December 8, 2023</completion_date>
    <primary_completion_date type="Anticipated">November 17, 2023</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Randomized</allocation>
      <intervention_model>Parallel Assignment</intervention_model>
      <primary_purpose>Other</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>11 point Likert Scale Questionnaire</measure>
      <time_frame>90 days</time_frame>
      <description>• Subjective scores will be collected from subjects on each attribute being assessed (e.g. visual appeal, ease of use, ease of cleaning, seal, comfort, overall performance etc.). Scores will be collected using an 11-point Likert Scale Questionnaire. Minimum value will be zero. Maximum value will be 10. A higher score indicates better outcomes. A score of 10 is considered very favorable, and a score of 0 is very unfavorable.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>11 point Likert Scale Questionnaire</measure>
      <time_frame>90 days</time_frame>
      <description>• Subject's subjective impression and comments comparing the prototype mask (Whitsundays Nasal) to the subject's current mask with regards to ease of use, visual appearance, seal, comfort, facial markings, noise and overall performance. • Scores will be collected using an 11-point Likert Scale Questionnaire. Minimum value will be zero. Maximum value will be 10. A higher score indicates better outcomes. A score of 10 is considered very favorable, and a score of 0 is very unfavorable.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Apnea Hypopnea Index (AHI)</measure>
      <time_frame>90 days</time_frame>
      <description>• The AHI recorded by the subject's PAP device while using their own mask will be compared to the AHI recorded by the subject's PAP device while using the Whitsundays mask. The AHI will be obtained from the ResMed AirView Compliance Reports downloaded from the subject's PAP device during the study visits.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Compliance</measure>
      <time_frame>90 days</time_frame>
      <description>• The subject's average daily hours of use of PAP therapy recorded by the subject's PAP device while using their own mask will be compared to the average daily hours of use recorded by the subject's PAP device while using the Whitsundays mask. The average daily hours of use will be obtained from the ResMed AirView Compliance Reports downloaded from the subject's PAP device during the study visits.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Leak</measure>
      <time_frame>90 days</time_frame>
      <description>The median air leak (L/minute) recorded by the subject's PAP device while using their own mask will be compared to the median air leak (L/minute) recorded by the subject's PAP device while using the Whitsundays mask. The median air leak will be obtained from the ResMed AirView Compliance Reports downloaded during the study visits.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Pressure Differences</measure>
      <time_frame>90 days</time_frame>
      <description>The median air pressure (cmH2O) used during PAP therapy recorded by the subject's PAP device while using their own mask will be compared to the median air pressure (cmH2O) recorded by the subject's PAP device while using the Whitsundays mask. The median air pressure levels will be obtained from the ResMed AirView Compliance Reports downloaded from the subject's PAP device during the study visits.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Frequency of Cushion Replacement</measure>
      <time_frame>90 days</time_frame>
      <description>• Subject's frequency of cushion replacement will be recorded using the Mask Cushion Change Form to be provided to Group B participants on Day 14 and every 2 weeks for the duration of the study. The Mask Cushion Change form will be provided to Group A participants who request a cushion change.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Reason for Cushion Replacement</measure>
      <time_frame>90 days</time_frame>
      <description>• Subject's reason for cushion replacement will be recorded using the Mask Cushion Change Form to be provided to Group B participants on Day 14 and every 2 weeks for the duration of the study. The Mask Cushion Change form will be provided to Group A participants who request a cushion change.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Deterioration of Mask</measure>
      <time_frame>90 days</time_frame>
      <description>• Photos of the subject's prototype mask system taken at 2-week intervals to observe any visual deterioration such as cracking, crazing, tears, dirt or stain build up</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">120</enrollment>
    <condition>Obstructive Sleep Apnea</condition>
    <arm_group>
      <arm_group_label>Group A provided with 1 Whitsundays Nasal mask without a spare mask cushion</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>• Provided with 1 Whitsundays Nasal mask without a spare mask cushion (To be provided as requested)</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Group B provided with 1 Whitsundays Nasal mask with 2 spare mask cushions</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>• Provided with 1 Whitsundays Nasal mask with 2 spare mask cushions</description>
    </arm_group>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>Group A : provided with 1 Whitsundays Nasal mask without a spare mask cushion</intervention_name>
      <description>Group A will be provided with 1 Whitsundays Nasal mask without a spare mask cushion (replacement cushions will only be provided when requested)</description>
      <arm_group_label>Group A provided with 1 Whitsundays Nasal mask without a spare mask cushion</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>Group B : provided with 1 Whitsundays Nasal mask with 2 spare mask cushions</intervention_name>
      <description>Group B will be provided with 1 Whitsundays Nasal mask with 2 spare mask cushions</description>
      <arm_group_label>Group B provided with 1 Whitsundays Nasal mask with 2 spare mask cushions</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Patients willing to give written informed consent&#xD;
  &#xD;
            -  Patients who can read and comprehend English&#xD;
  &#xD;
            -  Patients who ≥ 18 years of age&#xD;
  &#xD;
            -  Patients being treated for OSA with a PAP device for ≥ 6 months&#xD;
  &#xD;
            -  Patients currently using a ResMed PAP device (S9, AirSense 10 &amp; AirSense 11)&#xD;
               compatible with AirView (with cellular data connectivity and has been sending device&#xD;
               data to the cloud)&#xD;
  &#xD;
            -  Patients currently using ResMed AirFit N30i or Philips DreamWear™ Nasal&#xD;
  &#xD;
            -  Patients who are willing to try the prototype mask for up to 90 nights&#xD;
  &#xD;
            -  Patients who are willing to take photos of the prototype mask every 2 weeks for the&#xD;
               duration of the study&#xD;
  &#xD;
            -  Patients who reside in the USA and intend to stay in the USA for the next 6 months&#xD;
  &#xD;
            -  Patients with access to the internet (such as a smartphone or laptop) to complete&#xD;
               online surveys&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Patients using Bilevel flow generators&#xD;
  &#xD;
            -  Patients who are or may be pregnant&#xD;
  &#xD;
            -  Patients with a preexisting lung disease/condition that would predispose them to&#xD;
               pneumothorax (for example: COPD, lung cancer; fibrosis of the lungs; recent (&lt; 2years)&#xD;
               case of pneumonia or lung infection; lung injury.&#xD;
  &#xD;
            -  If you are pregnant or planning to become pregnant&#xD;
  &#xD;
            -  Patients believed to be unsuitable for inclusion by the researcher&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>William Hevener, RPSGT</last_name>
      <role>Principal Investigator</role>
      <affiliation>Sleep Data</affiliation>
    </overall_official>
    <overall_official>
      <last_name>Matthew Uhles, MS</last_name>
      <role>Principal Investigator</role>
      <affiliation>Clayton Sleep Institute</affiliation>
    </overall_official>
    <location>
      <facility>
        <name>Sleep Data</name>
        <address>
          <city>San Diego</city>
          <state>California</state>
          <zip>92123</zip>
          <country>United States</country>
        </address>
      </facility>
    </location>
    <location>
      <facility>
        <name>Clayton Sleep Institute</name>
        <address>
          <city>Saint Louis</city>
          <state>Missouri</state>
          <zip>63123</zip>
          <country>United States</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>July 18, 2023</study_first_submitted>
    <study_first_submitted_qc>September 6, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 13, 2023</study_first_posted>
    <last_update_submitted>September 6, 2023</last_update_submitted>
    <last_update_submitted_qc>September 6, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 13, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Sleep Apnea, Obstructive</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06036329
  org study id: SLP-23-02-01
  secondary id: D638-1118
  nct id: NCT06036329
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: Yes
  is unapproved device: Yes
  The goal of this multi-site, prospective, randomized, double arm study without blinding is to
        test the usability of the Whitsundays mask system at home by patients with Obstructive Sleep
        Apnea. The main questions it aims to answer are:
  
          -  How the Whitsundays masks performs in the home environment
  
          -  What is the subject's first impression of the Whitsundays mask and what is their
             preference compared to their own mask
  
          -  What is the difference between the subject's objective therapy data when using the
             Whitsundays mask compared to their own mask
  
          -  Is there wear and tear of the Whitsundays mask and how frequently do the cushions need
             replacement Participants will be asked to use the Whitsundays mask for 90 days, answer
             questionnaires about the initial impression of the mask, the performance of the mask,
             and their preference compared to their own mask. Researchers will compare one group of
             subjects who will be provided with cushion replacements to another group who will only
             be provided with cushion replacements upon request to determine the need for cushion
             replacement, its frequency, and the reasons for cushion replacement during home usage.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Other
  masking: None (Open Label)
  measure: 11 point Likert Scale Questionnaire
  time frame: 90 days
  description: • Subjective scores will be collected from subjects on each attribute being assessed (e.g. visual appeal, ease of use, ease of cleaning, seal, comfort, overall performance etc.). Scores will be collected using an 11-point Likert Scale Questionnaire. Minimum value will be zero. Maximum value will be 10. A higher score indicates better outcomes. A score of 10 is considered very favorable, and a score of 0 is very unfavorable.
  measure: 11 point Likert Scale Questionnaire
  time frame: 90 days
  description: • Subject's subjective impression and comments comparing the prototype mask (Whitsundays Nasal) to the subject's current mask with regards to ease of use, visual appearance, seal, comfort, facial markings, noise and overall performance. • Scores will be collected using an 11-point Likert Scale Questionnaire. Minimum value will be zero. Maximum value will be 10. A higher score indicates better outcomes. A score of 10 is considered very favorable, and a score of 0 is very unfavorable.
  measure: Apnea Hypopnea Index (AHI)
  time frame: 90 days
  description: • The AHI recorded by the subject's PAP device while using their own mask will be compared to the AHI recorded by the subject's PAP device while using the Whitsundays mask. The AHI will be obtained from the ResMed AirView Compliance Reports downloaded from the subject's PAP device during the study visits.
  measure: Compliance
  time frame: 90 days
  description: • The subject's average daily hours of use of PAP therapy recorded by the subject's PAP device while using their own mask will be compared to the average daily hours of use recorded by the subject's PAP device while using the Whitsundays mask. The average daily hours of use will be obtained from the ResMed AirView Compliance Reports downloaded from the subject's PAP device during the study visits.
  measure: Leak
  time frame: 90 days
  description: The median air leak (L/minute) recorded by the subject's PAP device while using their own mask will be compared to the median air leak (L/minute) recorded by the subject's PAP device while using the Whitsundays mask. The median air leak will be obtained from the ResMed AirView Compliance Reports downloaded during the study visits.
  measure: Pressure Differences
  time frame: 90 days
  description: The median air pressure (cmH2O) used during PAP therapy recorded by the subject's PAP device while using their own mask will be compared to the median air pressure (cmH2O) recorded by the subject's PAP device while using the Whitsundays mask. The median air pressure levels will be obtained from the ResMed AirView Compliance Reports downloaded from the subject's PAP device during the study visits.
  measure: Frequency of Cushion Replacement
  time frame: 90 days
  description: • Subject's frequency of cushion replacement will be recorded using the Mask Cushion Change Form to be provided to Group B participants on Day 14 and every 2 weeks for the duration of the study. The Mask Cushion Change form will be provided to Group A participants who request a cushion change.
  measure: Reason for Cushion Replacement
  time frame: 90 days
  description: • Subject's reason for cushion replacement will be recorded using the Mask Cushion Change Form to be provided to Group B participants on Day 14 and every 2 weeks for the duration of the study. The Mask Cushion Change form will be provided to Group A participants who request a cushion change.
  measure: Deterioration of Mask
  time frame: 90 days
  description: • Photos of the subject's prototype mask system taken at 2-week intervals to observe any visual deterioration such as cracking, crazing, tears, dirt or stain build up
  arm group label: Group A provided with 1 Whitsundays Nasal mask without a spare mask cushion
  arm group type: Experimental
  description: • Provided with 1 Whitsundays Nasal mask without a spare mask cushion (To be provided as requested)
  arm group label: Group B provided with 1 Whitsundays Nasal mask with 2 spare mask cushions
  arm group type: Experimental
  description: • Provided with 1 Whitsundays Nasal mask with 2 spare mask cushions
  intervention type: Device
  intervention name: Group A : provided with 1 Whitsundays Nasal mask without a spare mask cushion
  description: Group A will be provided with 1 Whitsundays Nasal mask without a spare mask cushion (replacement cushions will only be provided when requested)
  arm group label: Group A provided with 1 Whitsundays Nasal mask without a spare mask cushion
  intervention type: Device
  intervention name: Group B : provided with 1 Whitsundays Nasal mask with 2 spare mask cushions
  description: Group B will be provided with 1 Whitsundays Nasal mask with 2 spare mask cushions
  arm group label: Group B provided with 1 Whitsundays Nasal mask with 2 spare mask cushions
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: William Hevener, RPSGT
  role: Principal Investigator
  affiliation: Sleep Data
  last name: Matthew Uhles, MS
  role: Principal Investigator
  affiliation: Clayton Sleep Institute
  facility: 
  facility: 
  country: United States
  responsible party type: Sponsor
  mesh term: Sleep Apnea, Obstructive
  sharing ipd: No