<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/NCT03752580</url>
  </required_header>
  <id_info>
    <org_study_id>CIA-240</org_study_id>
    <nct_id>NCT03752580</nct_id>
  </id_info>
  <brief_title>An Investigation to Test a Prototype Nasal Mask in the Home Setting</brief_title>
  <official_title>An Investigation to Test a Prototype Nasal Mask in the Home Setting</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Fisher and Paykel Healthcare</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Fisher and Paykel Healthcare</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>
      This investigation is a prospective non-blinded and non-randomized clinical investigation.&#xD;
      This investigation is to test the interpretation of user instructions of a prototype nasal&#xD;
      mask on participants. The clinical investigation will be conducted in New Zealand and&#xD;
      participants will interact with the user instructions in a one hour daytime visit. A minimum&#xD;
      of 15 participants will participate in this trial.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This investigation is to test the interpretation of user instructions of a prototype nasal&#xD;
      mask on participants. The clinical investigation will be conducted in New Zealand and&#xD;
      participants will interact with the user instructions in a one hour daytime visit. This&#xD;
      investigation is designed to evaluate the interpretation by participants of the user&#xD;
      instructions. A total number of 20 participants, diagnosed with OSA will be recruited for the&#xD;
      trial. The participants will be recruited from the Fisher and Paykel Healthcare Database of&#xD;
      subjects (Ethics reference 18/NTA/62).&#xD;
&#xD;
      Fisher and Paykel Healthcare will act as the investigator and sponsor for this investigation.&#xD;
      This study will be conducted in accordance with ICH/GCP Guidelines. No deviation from&#xD;
      protocol will be implemented without prior review and approval of the sponsor except where it&#xD;
      may be necessary to eliminate an immediate hazard to a research participant. In such case,&#xD;
      the deviation will be reported to the sponsor (Bhavi Ogra) as soon as possible.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 15, 2018</start_date>
  <completion_date type="Actual">October 19, 2018</completion_date>
  <primary_completion_date type="Actual">October 18, 2018</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>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Mask User Instructions Interpretation</measure>
    <time_frame>3 days</time_frame>
    <description>Determined as interpreted by participants from open-ended questions (Open ended questionnaire, very easy - very difficult)- Subjective</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">20</enrollment>
  <condition>Sleep Disordered Breathing</condition>
  <condition>Obstructive Sleep Apnea</condition>
  <arm_group>
    <arm_group_label>Arm</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Experimental: User Instructions of a Novel Nasal Mask Participants to interpret user instructions in a one hour daytime visit.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>User Instructions of novel nasal mask</intervention_name>
    <description>User Unstructions interpretation of novel nasal mask for the treatment of obstructive sleep apnea (OSA).</description>
    <arm_group_label>Arm</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  OSA Mask Users&#xD;
&#xD;
          -  18+ years of age&#xD;
&#xD;
          -  Ability to give informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Inability to give informed consent&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Fisher &amp; Paykel Healthcare</name>
      <address>
        <city>Auckland</city>
        <zip>2013</zip>
        <country>New Zealand</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>New Zealand</country>
  </location_countries>
  <verification_date>July 2018</verification_date>
  <study_first_submitted>November 20, 2018</study_first_submitted>
  <study_first_submitted_qc>November 21, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 26, 2018</study_first_posted>
  <last_update_submitted>January 22, 2019</last_update_submitted>
  <last_update_submitted_qc>January 22, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">January 24, 2019</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 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/NCT03752580
org study id: CIA-240
nct id: NCT03752580
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
This investigation is a prospective non-blinded and non-randomized clinical investigation.
      This investigation is to test the interpretation of user instructions of a prototype nasal
      mask on participants. The clinical investigation will be conducted in New Zealand and
      participants will interact with the user instructions in a one hour daytime visit. A minimum
      of 15 participants will participate in this trial.
This investigation is to test the interpretation of user instructions of a prototype nasal
      mask on participants. The clinical investigation will be conducted in New Zealand and
      participants will interact with the user instructions in a one hour daytime visit. This
      investigation is designed to evaluate the interpretation by participants of the user
      instructions. A total number of 20 participants, diagnosed with OSA will be recruited for the
      trial. The participants will be recruited from the Fisher and Paykel Healthcare Database of
      subjects (Ethics reference 18/NTA/62).

      Fisher and Paykel Healthcare will act as the investigator and sponsor for this investigation.
      This study will be conducted in accordance with ICH/GCP Guidelines. No deviation from
      protocol will be implemented without prior review and approval of the sponsor except where it
      may be necessary to eliminate an immediate hazard to a research participant. In such case,
      the deviation will be reported to the sponsor (Bhavi Ogra) as soon as possible.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Mask User Instructions Interpretation
time frame: 3 days
description: Determined as interpreted by participants from open-ended questions (Open ended questionnaire, very easy - very difficult)- Subjective
arm group label: Arm
arm group type: Experimental
description: Experimental: User Instructions of a Novel Nasal Mask Participants to interpret user instructions in a one hour daytime visit.
intervention type: Device
intervention name: User Instructions of novel nasal mask
description: User Unstructions interpretation of novel nasal mask for the treatment of obstructive sleep apnea (OSA).
arm group label: Arm
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: New Zealand
responsible party type: Sponsor
mesh term: Sleep Apnea Syndromes
mesh term: Sleep Apnea, Obstructive