<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/NCT02265458</url>
  </required_header>
  <id_info>
    <org_study_id>P131201</org_study_id>
    <nct_id>NCT02265458</nct_id>
  </id_info>
  <brief_title>Musical Intervention in Non-invasive Ventilation</brief_title>
  <acronym>Mus-IRA</acronym>
  <official_title>Musical Intervention in the ICU: Effect on Tolerance and Acceptance of Non-invasive Ventilation</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Assistance Publique - Hôpitaux de Paris</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Assistance Publique - Hôpitaux de Paris</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Non-invasive ventilation (NIV) might be associated with anxiety, thus leading to NIV failure,&#xD;
      and intubation. Music therapy has been used in various clinical context, including in ICU&#xD;
      patients under mechanical ventilation. We aim to evaluate the effect of a musical&#xD;
      intervention on respiratory comfort during NIV for acute respiratory failure.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      We plan a randomized controlled trial with 3 different arms, in ICU patients requiring NIV&#xD;
      for acute respiratory failure : &quot;usual care&quot;, &quot;sensory isolation&quot; and &quot;sensory isolation and&#xD;
      musical intervention&quot;.At the onset of respiratory failure, each patient will be randomized in&#xD;
      one of the 3 arms. &quot;Usual care&quot; assigned patients will receive NIV according to each unit&#xD;
      protocol; &quot;sensory isolation&quot; assigned patients will receive NIV associated with a mask&#xD;
      obscuring the eyes and a noise-reducing headset.&quot;musical intervention patients&quot; will receive&#xD;
      a 30 minutes musical intervention during each NIV session. Respiratory discomfort will be&#xD;
      blindly assessed before, immediately after NIV is correctly set (5 minutes), at 30 minutes,&#xD;
      and at hours 1, 2, 3, 4, 6, 8, 12, 16, 20, 24 according to NIV session length, and at the end&#xD;
      of NIV session during each NIV session.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>May 2015</start_date>
  <completion_date type="Actual">January 2017</completion_date>
  <primary_completion_date type="Actual">October 2016</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>Treatment</primary_purpose>
    <masking>Single (Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Variation of respiratory discomfort during the 30 first minutes of NIV</measure>
    <time_frame>30 minutes</time_frame>
    <description>Measure of respiratory discomfort at the beginning and the end of the first NIV session, with an analogic visual scale.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Evolution of respiratory parameters</measure>
    <time_frame>participants will be followed for the duration of hospital stay or maximum 28 days</time_frame>
    <description>Measure of respiratory rate</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evolution of respiratory parameters</measure>
    <time_frame>participants will be followed for the duration of hospital stay or maximum 28 days</time_frame>
    <description>Transcutaneous oxygen saturation</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evolution of respiratory parameters</measure>
    <time_frame>participants will be followed for the duration of hospital stay or maximum 28 days</time_frame>
    <description>Respiratory tidal volume</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of NIV failure</measure>
    <time_frame>participants will be followed for the duration of hospital stay or maximum 28 days</time_frame>
    <description>NIV failure</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of life</measure>
    <time_frame>3 months</time_frame>
    <description>Questionnaire</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evolution of cardiovascular parameters</measure>
    <time_frame>participants will be followed for the duration of hospital stay or maximum 28 days</time_frame>
    <description>Measure of heart rate</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evolution of cardiovascular parameters</measure>
    <time_frame>participants will be followed for the duration of hospital stay or maximum 28 days</time_frame>
    <description>Measure of blood pressure</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Post traumatic stress disorder</measure>
    <time_frame>3 months</time_frame>
    <description>questionnaire</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>overall assessment of NIV (in terms of discomfort, satisfaction, and trauma)</measure>
    <time_frame>3 months</time_frame>
    <description>Questionnaire (scale)</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">114</enrollment>
  <condition>Respiratory Failure</condition>
  <arm_group>
    <arm_group_label>Musical intervention and sensory isolation</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>30 minutes musical intervention during NIV will be administrated, along with sensory isolation (mask obscuring the eyes)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Sensory isolation</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Sensory isolation</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Standard of care</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Standard of care</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Musical intervention and sensory isolation</intervention_name>
    <description>30 minutes musical intervention during NIV will be administrated, along with sensory isolation (mask obscuring the eyes)</description>
    <arm_group_label>Musical intervention and sensory isolation</arm_group_label>
    <arm_group_label>Sensory isolation</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  respiratory distress requiring NIV&#xD;
&#xD;
          -  Glasgow coma score above 12&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  NIV contraindication : Hemodynamic failure, neurologic failure, head trauma, vomiting&#xD;
&#xD;
          -  Severe hypoacusis people without hearing device&#xD;
&#xD;
          -  Decision to limit active treatment with an estimated life expectancy of less than 48&#xD;
             hours&#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>Jonathan MESSIKA, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>AP-HP Louis Mourier</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Hôpital Louis Mourier</name>
      <address>
        <city>Colombes</city>
        <zip>92700</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHD Vendée</name>
      <address>
        <city>La Roche Sur Yon</city>
        <zip>85925</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Institut Gustave Roussy</name>
      <address>
        <city>Villejuif</city>
        <zip>94800</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>January 2018</verification_date>
  <study_first_submitted>August 25, 2014</study_first_submitted>
  <study_first_submitted_qc>October 10, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 16, 2014</study_first_posted>
  <last_update_submitted>January 11, 2018</last_update_submitted>
  <last_update_submitted_qc>January 11, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">January 12, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Respiratory failure</keyword>
  <keyword>NIV</keyword>
  <keyword>Musical intervention</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Respiratory Insufficiency</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/NCT02265458
org study id: P131201
nct id: NCT02265458
lead sponsor: 
has dmc: No
Non-invasive ventilation (NIV) might be associated with anxiety, thus leading to NIV failure,
      and intubation. Music therapy has been used in various clinical context, including in ICU
      patients under mechanical ventilation. We aim to evaluate the effect of a musical
      intervention on respiratory comfort during NIV for acute respiratory failure.
We plan a randomized controlled trial with 3 different arms, in ICU patients requiring NIV
      for acute respiratory failure : "usual care", "sensory isolation" and "sensory isolation and
      musical intervention".At the onset of respiratory failure, each patient will be randomized in
      one of the 3 arms. "Usual care" assigned patients will receive NIV according to each unit
      protocol; "sensory isolation" assigned patients will receive NIV associated with a mask
      obscuring the eyes and a noise-reducing headset."musical intervention patients" will receive
      a 30 minutes musical intervention during each NIV session. Respiratory discomfort will be
      blindly assessed before, immediately after NIV is correctly set (5 minutes), at 30 minutes,
      and at hours 1, 2, 3, 4, 6, 8, 12, 16, 20, 24 according to NIV session length, and at the end
      of NIV session during each NIV session.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Investigator)
measure: Variation of respiratory discomfort during the 30 first minutes of NIV
time frame: 30 minutes
description: Measure of respiratory discomfort at the beginning and the end of the first NIV session, with an analogic visual scale.
measure: Evolution of respiratory parameters
time frame: participants will be followed for the duration of hospital stay or maximum 28 days
description: Measure of respiratory rate
measure: Evolution of respiratory parameters
time frame: participants will be followed for the duration of hospital stay or maximum 28 days
description: Transcutaneous oxygen saturation
measure: Evolution of respiratory parameters
time frame: participants will be followed for the duration of hospital stay or maximum 28 days
description: Respiratory tidal volume
measure: Number of NIV failure
time frame: participants will be followed for the duration of hospital stay or maximum 28 days
description: NIV failure
measure: Quality of life
time frame: 3 months
description: Questionnaire
measure: Evolution of cardiovascular parameters
time frame: participants will be followed for the duration of hospital stay or maximum 28 days
description: Measure of heart rate
measure: Evolution of cardiovascular parameters
time frame: participants will be followed for the duration of hospital stay or maximum 28 days
description: Measure of blood pressure
measure: Post traumatic stress disorder
time frame: 3 months
description: questionnaire
measure: overall assessment of NIV (in terms of discomfort, satisfaction, and trauma)
time frame: 3 months
description: Questionnaire (scale)
arm group label: Musical intervention and sensory isolation
arm group type: Experimental
description: 30 minutes musical intervention during NIV will be administrated, along with sensory isolation (mask obscuring the eyes)
arm group label: Sensory isolation
arm group type: Active Comparator
description: Sensory isolation
arm group label: Standard of care
arm group type: No Intervention
description: Standard of care
intervention type: Behavioral
intervention name: Musical intervention and sensory isolation
description: 30 minutes musical intervention during NIV will be administrated, along with sensory isolation (mask obscuring the eyes)
arm group label: Musical intervention and sensory isolation
arm group label: Sensory isolation
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Jonathan MESSIKA, MD
role: Principal Investigator
affiliation: AP-HP Louis Mourier
facility: 
facility: 
facility: 
country: France
responsible party type: Sponsor
mesh term: Respiratory Insufficiency
sharing ipd: Undecided