<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/NCT03013283</url>
  </required_header>
  <id_info>
    <org_study_id>RECHMPL16_0337</org_study_id>
    <nct_id>NCT03013283</nct_id>
  </id_info>
  <brief_title>CPAP and NIV Interfaces : Side-effects in Home Care Patients</brief_title>
  <acronym>InterfaceVent</acronym>
  <official_title>Descriptional Study of the Side Effects Related to the Use of the Interface in Home Care Patients Treated for at Least 3 Months by Continuous Positive Pressure or Non-Invasive Ventilation.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Montpellier</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Hospital, Montpellier</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Home ventilation techniques consist mainly of two techniques, Continuous Positive Airway&#xD;
      Pressure or CPAP and Non Invasive Ventilation or NIV. Whether for CPAP or NIV, pressures are&#xD;
      delivered to the patient via an interface.&#xD;
&#xD;
      The efficacy of CPAP and NIV is conditioned in part by the observance of the patients to the&#xD;
      device. Because the comfort and degree of satisfaction of the patients to its interface is a&#xD;
      key factor of the observance, side-effects and satisfaction of patients need to be&#xD;
      continuously evaluated with available interfaces for CPAP and NIV treated patients.&#xD;
&#xD;
      The purpose of the research is the evaluation of interface side-effects and the degree of&#xD;
      satisfaction of home care patients treated for at least three months with CPAP or NIV.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Home ventilation techniques consist mainly of two techniques, Continuous Positive Airway&#xD;
      Pressure or CPAP (the level of pressure delivered being constant) and Non Invasive&#xD;
      Ventilation or NIV (pressure level varies from an expiratory pressure to an inspiratory&#xD;
      pressure). Whether for CPAP or NIV, pressures are delivered to the patient via an interface.&#xD;
      Many manufacturers produce interfaces and these interfaces are the subject of regular&#xD;
      technological innovations with the introduction on the market of new product ranges.&#xD;
&#xD;
      Because of the lack of dedicated and actualized studies, there is poor evidence based of&#xD;
      difference between old and new interfaces, there is also poor evidence based of differences&#xD;
      between manufacturer products.&#xD;
&#xD;
      The efficacy of CPAP and NIV is conditioned in part by the observance of the patients to the&#xD;
      device. Because the comfort and degree of satisfaction of the patients to its interface is a&#xD;
      key factor of the observance, side-effects and satisfaction of patients need to be&#xD;
      continuously evaluated with available interfaces for CPAP and NIV treated patients.&#xD;
&#xD;
      The purpose of the research is the evaluation of interface side-effects and the degree of&#xD;
      satisfaction of home care patients treated for at least three months with CPAP or NIV. A&#xD;
      visual analog scale is used to assess the patient perception of its interface. A measure of&#xD;
      the quality of life and a home care technician evaluation are performed simultaneously. Using&#xD;
      the device manufacturer software, a measure of the observance, level of pressure and leak is&#xD;
      realised.&#xD;
&#xD;
      A first intermediate analysis will be made after approximately 1000 inclusions (the&#xD;
      Sleepileaks (determinants of residual excessive sleapiness), Threshleaks (high leak levels&#xD;
      and machine adherence as defined by the American Thoracic Society) and Complileaks studies&#xD;
      (all leaks and machine adherence as continuous variables)). A second validating analysis will&#xD;
      be made at the end of inclusions.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 7, 2017</start_date>
  <completion_date type="Actual">April 1, 2019</completion_date>
  <primary_completion_date type="Actual">April 1, 2019</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Interface side effects and degree of satisfaction of the patients</measure>
    <time_frame>1 day</time_frame>
    <description>During a scheduled home visit of the technician. The primary endpoint is a composite criterion corresponding to the patients' responses to a self-administered questionnaire.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Identification by the technician of the problems of pain</measure>
    <time_frame>1 day</time_frame>
    <description>During a scheduled home visit of the technician : Identification by the technician of the problems of pain, erythema and leak, localization of these problems.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of patients with oxygen therapy, heated humidifier, chinstrap.</measure>
    <time_frame>1 day</time_frame>
    <description>During a scheduled home visit of the technician : Percentage of patients with oxygen therapy, heated humidifier, chinstrap.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Collection by technician of the type of interface</measure>
    <time_frame>1 day</time_frame>
    <description>During a scheduled home visit of the technician : Collection by technician of the type of interface (nasal pillows, nasal and oronasal, custom made interface), manufacturer name and interface size, type (CPAP/NIV) and manufacturer name of the device.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Compliance</measure>
    <time_frame>1 day</time_frame>
    <description>During a scheduled home visit of the technician : Device software data: compliance (hour per day) over the last 3 months</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Average level of intentional or unintentional leakage</measure>
    <time_frame>1 day</time_frame>
    <description>During a scheduled home visit of the technician : Device software data: average level of intentional or unintentional leakage (l/min)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Residual AHI</measure>
    <time_frame>1 day</time_frame>
    <description>During a scheduled home visit of the technician : Device software data: residual AHI (event/hour)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Average pressure level and pressure</measure>
    <time_frame>1 day</time_frame>
    <description>During a scheduled home visit of the technician :Device software data: average pressure level and pressure at the 90/95th percentile (cmH2O).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient quality of life questionnaire</measure>
    <time_frame>1 day</time_frame>
    <description>Patient quality of life questionnaire (EQ-5D 3L, Epworth).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Date of first installation of the first ventilation device</measure>
    <time_frame>1 day</time_frame>
    <description>Date of first installation of the first ventilation device</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportion of patient responding to self-help questionnaire without assistance</measure>
    <time_frame>1 day</time_frame>
    <description>Proportion of patient responding to self-help questionnaire without assistance</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportion of patients able to position the interface without assistance</measure>
    <time_frame>1 day</time_frame>
    <description>Proportion of patients able to position the interface without assistance</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time taken by the patient and the technician to answer the patient's self-questionnaire and the technician record respectively.</measure>
    <time_frame>1 day</time_frame>
    <description>Time taken by the patient and the technician to answer the patient's self-questionnaire and the technician record respectively.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportion of patient waiting for a new interface</measure>
    <time_frame>1 day</time_frame>
    <description>Proportion of patient waiting for a new interface</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportion of patients wishing to participate in research on the subject.</measure>
    <time_frame>1 day</time_frame>
    <description>Proportion of patients wishing to participate in research on the subject.</description>
  </secondary_outcome>
  <enrollment type="Actual">6000</enrollment>
  <condition>Interface, Mask</condition>
  <condition>Continuous Positive Airway Pressure (CPAP)</condition>
  <condition>Non Invasive Ventilation (NIV)</condition>
  <condition>Hyperventilation Anxiety</condition>
  <condition>Sleep Apnea Syndrome (OSAS)</condition>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>self questionnaire</intervention_name>
    <description>Interface side effects and degree of satisfaction of the patients&#xD;
Technician evaluation and device measures.</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        The patients included in the study corresponded to the annual cohort of patients cared by&#xD;
        the APARD home care provider. Patients are were treated with CPAP or VIN for more than 3&#xD;
        months according to the criteria of care and reimbursement of the French Social Security&#xD;
        rules.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Written informed consent&#xD;
&#xD;
          -  Age more than 18 years (inclusive)&#xD;
&#xD;
          -  Patient treated with CPAP or NIV for at least three months,and eligible for care and&#xD;
             for the reimbursement by the French Social Security rules.&#xD;
&#xD;
          -  Patient presents during a scheduled home visit of the technician for the continuation&#xD;
             of CPAP or NIV treatment according to the French Social Security rules.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pregnancy, intention of being pregnant, breastfeeding.&#xD;
&#xD;
          -  Inability to understand the nature and aims of the study or to communicate with the&#xD;
             investigator&#xD;
&#xD;
          -  Simultaneous participation in another trial with an exclusion clause to participate to&#xD;
             an other trial.&#xD;
&#xD;
          -  No affiliation to the French social security&#xD;
&#xD;
          -  Loss of personal capacity resulting in state protection&#xD;
&#xD;
          -  Deprivation of liberty by judicial or administrative decision&#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>Dany JAFFUEL, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University Hospital, Montpellier</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Centre Hospitalier Universitaire de Montpellier</name>
      <address>
        <city>Montpellier</city>
        <zip>34295</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU Saint-Etienne</name>
      <address>
        <city>Saint-Etienne</city>
        <zip>42055</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <link>
    <url>https://osf.io/sy3nq/</url>
    <description>InterfaceVent on the Open Science Framework</description>
  </link>
  <results_reference>
    <citation>Rotty MC, Mallet JP, Suehs CM, Martinez C, Borel JC, Rabec C, Bourdin A, Molinari N, Jaffuel D. Is the 2013 American Thoracic Society CPAP-tracking system algorithm useful for managing non-adherence in long-term CPAP-treated patients? Respir Res. 2019 Sep 12;20(1):209. doi: 10.1186/s12931-019-1150-7.</citation>
    <PMID>31514751</PMID>
  </results_reference>
  <results_reference>
    <citation>Rotty MC, Suehs CM, Mallet JP, Martinez C, Borel JC, Rabec C, Bertelli F, Bourdin A, Molinari N, Jaffuel D. Mask side-effects in long-term CPAP-patients impact adherence and sleepiness: the InterfaceVent real-life study. Respir Res. 2021 Jan 15;22(1):17. doi: 10.1186/s12931-021-01618-x.</citation>
    <PMID>33451313</PMID>
  </results_reference>
  <verification_date>April 2019</verification_date>
  <study_first_submitted>December 23, 2016</study_first_submitted>
  <study_first_submitted_qc>January 5, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 6, 2017</study_first_posted>
  <last_update_submitted>January 24, 2021</last_update_submitted>
  <last_update_submitted_qc>January 24, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">January 27, 2021</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>Hyperventilation</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03013283
org study id: RECHMPL16_0337
nct id: NCT03013283
lead sponsor: 
has dmc: No
Home ventilation techniques consist mainly of two techniques, Continuous Positive Airway
      Pressure or CPAP and Non Invasive Ventilation or NIV. Whether for CPAP or NIV, pressures are
      delivered to the patient via an interface.

      The efficacy of CPAP and NIV is conditioned in part by the observance of the patients to the
      device. Because the comfort and degree of satisfaction of the patients to its interface is a
      key factor of the observance, side-effects and satisfaction of patients need to be
      continuously evaluated with available interfaces for CPAP and NIV treated patients.

      The purpose of the research is the evaluation of interface side-effects and the degree of
      satisfaction of home care patients treated for at least three months with CPAP or NIV.
Home ventilation techniques consist mainly of two techniques, Continuous Positive Airway
      Pressure or CPAP (the level of pressure delivered being constant) and Non Invasive
      Ventilation or NIV (pressure level varies from an expiratory pressure to an inspiratory
      pressure). Whether for CPAP or NIV, pressures are delivered to the patient via an interface.
      Many manufacturers produce interfaces and these interfaces are the subject of regular
      technological innovations with the introduction on the market of new product ranges.

      Because of the lack of dedicated and actualized studies, there is poor evidence based of
      difference between old and new interfaces, there is also poor evidence based of differences
      between manufacturer products.

      The efficacy of CPAP and NIV is conditioned in part by the observance of the patients to the
      device. Because the comfort and degree of satisfaction of the patients to its interface is a
      key factor of the observance, side-effects and satisfaction of patients need to be
      continuously evaluated with available interfaces for CPAP and NIV treated patients.

      The purpose of the research is the evaluation of interface side-effects and the degree of
      satisfaction of home care patients treated for at least three months with CPAP or NIV. A
      visual analog scale is used to assess the patient perception of its interface. A measure of
      the quality of life and a home care technician evaluation are performed simultaneously. Using
      the device manufacturer software, a measure of the observance, level of pressure and leak is
      realised.

      A first intermediate analysis will be made after approximately 1000 inclusions (the
      Sleepileaks (determinants of residual excessive sleapiness), Threshleaks (high leak levels
      and machine adherence as defined by the American Thoracic Society) and Complileaks studies
      (all leaks and machine adherence as continuous variables)). A second validating analysis will
      be made at the end of inclusions.
observational model: Cohort
time perspective: Prospective
measure: Interface side effects and degree of satisfaction of the patients
time frame: 1 day
description: During a scheduled home visit of the technician. The primary endpoint is a composite criterion corresponding to the patients' responses to a self-administered questionnaire.
measure: Identification by the technician of the problems of pain
time frame: 1 day
description: During a scheduled home visit of the technician : Identification by the technician of the problems of pain, erythema and leak, localization of these problems.
measure: Percentage of patients with oxygen therapy, heated humidifier, chinstrap.
time frame: 1 day
description: During a scheduled home visit of the technician : Percentage of patients with oxygen therapy, heated humidifier, chinstrap.
measure: Collection by technician of the type of interface
time frame: 1 day
description: During a scheduled home visit of the technician : Collection by technician of the type of interface (nasal pillows, nasal and oronasal, custom made interface), manufacturer name and interface size, type (CPAP/NIV) and manufacturer name of the device.
measure: Compliance
time frame: 1 day
description: During a scheduled home visit of the technician : Device software data: compliance (hour per day) over the last 3 months
measure: Average level of intentional or unintentional leakage
time frame: 1 day
description: During a scheduled home visit of the technician : Device software data: average level of intentional or unintentional leakage (l/min)
measure: Residual AHI
time frame: 1 day
description: During a scheduled home visit of the technician : Device software data: residual AHI (event/hour)
measure: Average pressure level and pressure
time frame: 1 day
description: During a scheduled home visit of the technician :Device software data: average pressure level and pressure at the 90/95th percentile (cmH2O).
measure: Patient quality of life questionnaire
time frame: 1 day
description: Patient quality of life questionnaire (EQ-5D 3L, Epworth).
measure: Date of first installation of the first ventilation device
time frame: 1 day
description: Date of first installation of the first ventilation device
measure: Proportion of patient responding to self-help questionnaire without assistance
time frame: 1 day
description: Proportion of patient responding to self-help questionnaire without assistance
measure: Proportion of patients able to position the interface without assistance
time frame: 1 day
description: Proportion of patients able to position the interface without assistance
measure: Time taken by the patient and the technician to answer the patient's self-questionnaire and the technician record respectively.
time frame: 1 day
description: Time taken by the patient and the technician to answer the patient's self-questionnaire and the technician record respectively.
measure: Proportion of patient waiting for a new interface
time frame: 1 day
description: Proportion of patient waiting for a new interface
measure: Proportion of patients wishing to participate in research on the subject.
time frame: 1 day
description: Proportion of patients wishing to participate in research on the subject.
intervention type: Other
intervention name: self questionnaire
description: Interface side effects and degree of satisfaction of the patients
Technician evaluation and device measures.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Dany JAFFUEL, MD, PhD
role: Principal Investigator
affiliation: University Hospital, Montpellier
facility: 
facility: 
country: France
url: https://osf.io/sy3nq/
description: InterfaceVent on the Open Science Framework
citation: Rotty MC, Mallet JP, Suehs CM, Martinez C, Borel JC, Rabec C, Bourdin A, Molinari N, Jaffuel D. Is the 2013 American Thoracic Society CPAP-tracking system algorithm useful for managing non-adherence in long-term CPAP-treated patients? Respir Res. 2019 Sep 12;20(1):209. doi: 10.1186/s12931-019-1150-7.
PMID: 31514751
citation: Rotty MC, Suehs CM, Mallet JP, Martinez C, Borel JC, Rabec C, Bertelli F, Bourdin A, Molinari N, Jaffuel D. Mask side-effects in long-term CPAP-patients impact adherence and sleepiness: the InterfaceVent real-life study. Respir Res. 2021 Jan 15;22(1):17. doi: 10.1186/s12931-021-01618-x.
PMID: 33451313
responsible party type: Sponsor
mesh term: Sleep Apnea Syndromes
mesh term: Hyperventilation
sharing ipd: Undecided