<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/NCT03247907</url>
  </required_header>
  <id_info>
    <org_study_id>CIA-191</org_study_id>
    <nct_id>NCT03247907</nct_id>
  </id_info>
  <brief_title>Humidification Needs</brief_title>
  <official_title>Humidification Needs</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>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      A study undertaken to investigate mouth leak for airway discomfort/dryness while using CPAP.&#xD;
      This study will also measure how much humidification is required to treat subsequent upper&#xD;
      airway discomfort/dryness from mouth leak by utilizing different levels and types of&#xD;
      humidification.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Trial was terminated by investigators due to equipment difficulties&#xD;
  </why_stopped>
  <start_date type="Actual">October 9, 2017</start_date>
  <completion_date type="Actual">September 30, 2018</completion_date>
  <primary_completion_date type="Actual">September 30, 2018</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>Crossover Assignment</intervention_model>
    <primary_purpose>Other</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Nasal Resistance</measure>
    <time_frame>8 Days</time_frame>
    <description>Will be measured by rhinomanometer or acoustic rhinometry</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Evaluation of Nasal Dryness and Discomfort</measure>
    <time_frame>8 Days</time_frame>
    <description>Reported by participants using the Xero Questionnaire</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Preference of Testing Condition</measure>
    <time_frame>8 Days</time_frame>
    <description>Measured by custom preference questionnaire</description>
  </secondary_outcome>
  <number_of_arms>8</number_of_arms>
  <enrollment type="Actual">10</enrollment>
  <condition>Obstructive Sleep Apnea</condition>
  <arm_group>
    <arm_group_label>Condition A: CPAP with No Humidification</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>CPAP with No Humidification with no mouth leak</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Condition B: CPAP with No Humidification</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>CPAP with No Humidification with mouth leak</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Condition C: CPAP with Cold Passover humidifier</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>CPAP with Cold Passover humidifier with mouth leak</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Condition D: CPAP with Modified Humidifier</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>CPAP with Modified Humidifier with mouth leak</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Condition E: CPAP with Ambient Tracking</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>CPAP with Ambient Tracking with mouth leak</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Condition F: CPAP with Heated Humidification</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>CPAP with Heated Humidification at default setting with mouth leak</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Condition G: CPAP with Heated Humidification</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>CPAP with Heated Humidification at max setting with mouth leak</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Condition H: CPAP with New level humidification</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>CPAP with New level humidification with mouth leak</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Condition A: CPAP with No Humidification</intervention_name>
    <description>CPAP with No Humidification with no mouth leak</description>
    <arm_group_label>Condition A: CPAP with No Humidification</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Condition B: CPAP with No Humidification</intervention_name>
    <description>CPAP with No Humidification with mouth leak</description>
    <arm_group_label>Condition B: CPAP with No Humidification</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Condition C: CPAP with Cold Passover</intervention_name>
    <description>CPAP with Cold Passover with mouth leak</description>
    <arm_group_label>Condition C: CPAP with Cold Passover humidifier</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Condition D: CPAP with Modified humidifier</intervention_name>
    <description>CPAP with Modified humidifier with mouth leak</description>
    <arm_group_label>Condition D: CPAP with Modified Humidifier</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Condition E: CPAP with Ambient Tracking</intervention_name>
    <description>CPAP with Ambient Tracking with mouth leak</description>
    <arm_group_label>Condition E: CPAP with Ambient Tracking</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Condition F: CPAP with Heated Humidification</intervention_name>
    <description>CPAP with Heated Humidification at default setting with mouth leak</description>
    <arm_group_label>Condition F: CPAP with Heated Humidification</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Condition G: CPAP with Heated Humidification</intervention_name>
    <description>CPAP with Heated Humidification at max setting with mouth leak</description>
    <arm_group_label>Condition G: CPAP with Heated Humidification</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Condition H: CPAP with New level humidification</intervention_name>
    <description>CPAP with New level humidification with mouth leak</description>
    <arm_group_label>Condition H: CPAP with New level humidification</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Aged 18 and over&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Inability to give consent&#xD;
&#xD;
          -  Currently pregnant or think they may be pregnant&#xD;
&#xD;
          -  Current nasal symptoms or chronic nasal disease&#xD;
&#xD;
          -  Contraindicated for PAP therapy&#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 and Paykel Healthcare</name>
      <address>
        <city>East Tamaki</city>
        <state>Auckland</state>
        <zip>2013</zip>
        <country>New Zealand</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>New Zealand</country>
  </location_countries>
  <verification_date>April 2019</verification_date>
  <study_first_submitted>August 7, 2017</study_first_submitted>
  <study_first_submitted_qc>August 9, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 14, 2017</study_first_posted>
  <last_update_submitted>April 17, 2019</last_update_submitted>
  <last_update_submitted_qc>April 17, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">April 19, 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, 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/NCT03247907
org study id: CIA-191
nct id: NCT03247907
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
is us export: No
A study undertaken to investigate mouth leak for airway discomfort/dryness while using CPAP.
      This study will also measure how much humidification is required to treat subsequent upper
      airway discomfort/dryness from mouth leak by utilizing different levels and types of
      humidification.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Other
masking: Single (Participant)
measure: Nasal Resistance
time frame: 8 Days
description: Will be measured by rhinomanometer or acoustic rhinometry
measure: Evaluation of Nasal Dryness and Discomfort
time frame: 8 Days
description: Reported by participants using the Xero Questionnaire
measure: Preference of Testing Condition
time frame: 8 Days
description: Measured by custom preference questionnaire
arm group label: Condition A: CPAP with No Humidification
arm group type: Active Comparator
description: CPAP with No Humidification with no mouth leak
arm group label: Condition B: CPAP with No Humidification
arm group type: Active Comparator
description: CPAP with No Humidification with mouth leak
arm group label: Condition C: CPAP with Cold Passover humidifier
arm group type: Active Comparator
description: CPAP with Cold Passover humidifier with mouth leak
arm group label: Condition D: CPAP with Modified Humidifier
arm group type: Active Comparator
description: CPAP with Modified Humidifier with mouth leak
arm group label: Condition E: CPAP with Ambient Tracking
arm group type: Active Comparator
description: CPAP with Ambient Tracking with mouth leak
arm group label: Condition F: CPAP with Heated Humidification
arm group type: Active Comparator
description: CPAP with Heated Humidification at default setting with mouth leak
arm group label: Condition G: CPAP with Heated Humidification
arm group type: Active Comparator
description: CPAP with Heated Humidification at max setting with mouth leak
arm group label: Condition H: CPAP with New level humidification
arm group type: Active Comparator
description: CPAP with New level humidification with mouth leak
intervention type: Device
intervention name: Condition A: CPAP with No Humidification
description: CPAP with No Humidification with no mouth leak
arm group label: Condition A: CPAP with No Humidification
intervention type: Device
intervention name: Condition B: CPAP with No Humidification
description: CPAP with No Humidification with mouth leak
arm group label: Condition B: CPAP with No Humidification
intervention type: Device
intervention name: Condition C: CPAP with Cold Passover
description: CPAP with Cold Passover with mouth leak
arm group label: Condition C: CPAP with Cold Passover humidifier
intervention type: Device
intervention name: Condition D: CPAP with Modified humidifier
description: CPAP with Modified humidifier with mouth leak
arm group label: Condition D: CPAP with Modified Humidifier
intervention type: Device
intervention name: Condition E: CPAP with Ambient Tracking
description: CPAP with Ambient Tracking with mouth leak
arm group label: Condition E: CPAP with Ambient Tracking
intervention type: Device
intervention name: Condition F: CPAP with Heated Humidification
description: CPAP with Heated Humidification at default setting with mouth leak
arm group label: Condition F: CPAP with Heated Humidification
intervention type: Device
intervention name: Condition G: CPAP with Heated Humidification
description: CPAP with Heated Humidification at max setting with mouth leak
arm group label: Condition G: CPAP with Heated Humidification
intervention type: Device
intervention name: Condition H: CPAP with New level humidification
description: CPAP with New level humidification with mouth leak
arm group label: Condition H: CPAP with New level humidification
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, Obstructive