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/NCT06021938</url>
    </required_header>
    <id_info>
      <org_study_id>APHP230974</org_study_id>
      <nct_id>NCT06021938</nct_id>
    </id_info>
    <brief_title>Alleviating Persistent Dyspnea in Amyotrophic Lateral Sclerosis Patients Treated With Non-Invasive Ventilation Through Immersive Virtual Reality</brief_title>
    <acronym>RVI-SLA</acronym>
    <official_title>Alleviating Persistent Dyspnea in Amyotrophic Lateral Sclerosis Patients Treated With Non-Invasive Ventilation Through Immersive Virtual Reality</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>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        The evolution of amyotrophic lateral sclerosis (ALS) is marked by dyspnea, anxiety and pain,&#xD;
        major determinants of suffering induced by this disease. The only palliative treatment for&#xD;
        respiratory failure is non-invasive ventilation (NIV), which compensates failing respiratory&#xD;
        muscles and relieves dyspnea, improves quality of life and increases life expectancy. In ALS&#xD;
        patients, the persistence of dyspnea outside of NIV sessions has highlighted the need for&#xD;
        therapeutic alternatives in the treatment of persistent dyspnea, including immersive virtual&#xD;
        reality (IVR) and auditory distraction through music (music therapy). This study evaluates&#xD;
        the effect of IVR on respiratory discomfort in ALS patients with persistent dyspnea treated&#xD;
        with NIV.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        The evolution of amyotrophic lateral sclerosis (ALS) is marked by dyspnea, anxiety and pain,&#xD;
        major determinants of suffering induced by this disease. The only palliative treatment for&#xD;
        respiratory failure is non-invasive ventilation (NIV), which compensates failing respiratory&#xD;
        muscles and relieves dyspnea, improves quality of life and increases life expectancy. In ALS&#xD;
        patients, the persistence of dyspnea outside of NIV sessions has highlighted the need for&#xD;
        therapeutic alternatives in the treatment of persistent dyspnea, including immersive virtual&#xD;
        reality (IVR) and auditory distraction through music (music therapy). The objective of this&#xD;
        study is to evaluate the effect of IVR on respiratory discomfort (scale A1 of the&#xD;
        Multidimensional Dyspnea Profile (MDP) questionnaire) of patients with ALS at the stage of&#xD;
        respiratory failure treated with NIV. This will be an open-label, monocentric, randomized,&#xD;
        controlled cross-over clinical study. ALS patients will be recruited during their respiratory&#xD;
        evaluation carried out as part of their usual care provided in an ambulatory setting (day&#xD;
        care hospital) in the Pneumology Department of Pitié Salpêtrière Hospital. Eligibility&#xD;
        criteria will be verified during this visit. If the patient meets eligibility criteria, the&#xD;
        investigator will present the study to him using the information letter. After a period of&#xD;
        reflection that the patient deems necessary to make his decision and after having obtained an&#xD;
        answer to all his questions, his written consent will be collected by the investigator. The&#xD;
        patient will then be offered a digital therapy session based on immersive virtual reality&#xD;
        (IVR) and a music therapy session, 60 minutes apart. The IVR session will be based on medical&#xD;
        hypnosis (GAMIDA®) and the music therapy session will be based on the choice of music that&#xD;
        the patient wishes. Each session will last 15 minutes. Patients will start either with the&#xD;
        medical hypnosis session by IVR or with the music session depending on the randomization&#xD;
        carried out before the start of the study. The random order will be provided by software&#xD;
        (CleanWeb).&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">November 2023</start_date>
    <completion_date type="Anticipated">November 2025</completion_date>
    <primary_completion_date type="Anticipated">November 2025</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>Supportive Care</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Evaluate the effect of IVR on respiratory discomfort (A1)</measure>
      <time_frame>15 minutes</time_frame>
      <description>Evaluate the effect of IVR on respiratory discomfort (scale A1 of the MDP questionnaire) of patients with ALS at the stage of respiratory failure treated with NIV</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Evaluate the effect of IVR on respiratory discomfort (QS and A2)</measure>
      <time_frame>15 minutes</time_frame>
      <description>Evaluate the effect of IVR on the sensory (scale QS of the MDP questionnaire) and emotional (scale A2 of the MDP questionnaire) components of dyspnea of patients with ALS at the stage of respiratory failure treated with NIV.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Evaluate the effect of music therapy on respiratory discomfort (QS, A1 and A2)</measure>
      <time_frame>15 minutes</time_frame>
      <description>Evaluate the effect of music therapy on the sensory (scale QS of the MDP questionnaire), affective (scale A1 of the MDP questionnaire) and emotional (scale A2 of the MDP questionnaire) components of dyspnea of patients with ALS at the stage of respiratory failure treated with NIV.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Compare the evolutionary profile on respiratory discomfort (QS, A1 and A2) under the effect of IVR and music therapy</measure>
      <time_frame>15 minutes</time_frame>
      <description>Compare the evolutionary profile of the sensory ( scale QS of the MDP questionnaire ) and affective ( scale A1 and A2 of the MDP questionnaire) components of dyspnea under the effect of IVR and music therapy.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Compare the effect of IVR and music therapy on the respiratory discomfort in terms of preference.</measure>
      <time_frame>15 minutes</time_frame>
      <description>Compare the effect of IVR and music therapy on the respiratory discomfort of ALS patients treated with NIV in terms of preference through a post-exposure questionnaire after the two interventions</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Evaluate the acceptability of IVR</measure>
      <time_frame>15 minutes</time_frame>
      <description>Evaluate the effect of IVR on dyspnea in terms of acceptability by a subjective questionnaire of six questions using a 7-point Likert scale.</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">35</enrollment>
    <condition>Amyotrophic Lateral Sclerosis</condition>
    <arm_group>
      <arm_group_label>Patients starting with RVI</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Patients will begin by wear a virtual reality headset (GAMIDA®) and headphones (Bose®). A tablet (Samsung®) equipped with &quot;Healthy Mind&quot; software will allow patients to live a 360° visual and auditory 3D experience via Bluetooth connection. After that patients will be handed a smartphone with the Spotify® application to listen to music. Patients will wear headphones.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Patients starting with music therapy</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Patients will begin by handed a smartphone with the Spotify® application to listen to music. Patients will wear headphones. After that patients will wear a virtual reality headset (GAMIDA®) and headphones (Bose®). A tablet (Samsung®) equipped with &quot;Healthy Mind&quot; software will allow patients to live a 360° visual and auditory 3D experience via Bluetooth connection.</description>
    </arm_group>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>Immersive virtual reality (IVR) &amp; Music therapy</intervention_name>
      <description>The patient will be offered a digital therapy session based on immersive virtual reality (IVR) and a music therapy session, 60 minutes apart. The IVR session will be based on medical hypnosis (GAMIDA®) and the music therapy session will be based on the choice of music the patient wishes. Each session will last 15 minutes. Patients will start either with the medical hypnosis session by IVR or with the music session depending on the randomization carried out before the start of the study. The random order will be provided by software (CleanWeb).</description>
      <arm_group_label>Patients starting with RVI</arm_group_label>
      <arm_group_label>Patients starting with music therapy</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  ≥ 18 years old&#xD;
  &#xD;
            -  Diagnosis of ALS confirmed according to the revised criteria of El Escorial&#xD;
  &#xD;
            -  Respiratory failure due to diaphragmatic dysfunction treated by non-invasive&#xD;
               ventilation for more than a month&#xD;
  &#xD;
            -  Care provided in an ambulatory setting (day care hospital)&#xD;
  &#xD;
            -  Persistent dyspnea at rest ≥ 3 across a numerical scale (0 to 10) in a semi-sitting&#xD;
               position&#xD;
  &#xD;
            -  Stable clinical condition, i.e., no episode of acute cardiac, respiratory and/or&#xD;
               neurological failure leading to hospitalization in the previous 4 weeks&#xD;
  &#xD;
            -  Free, prior and informed written consent about the study has been obtained&#xD;
  &#xD;
            -  Benefiting a social security (French health insurance system)&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Neurological disorders according to a neurological evaluation dating from less than&#xD;
               one year, in particular diagnosed dementia (frontotemporal dementia, Alzheimer's&#xD;
               disease, etc.), brain pathology (tumor, stroke, Parkinson's disease, etc.)&#xD;
  &#xD;
            -  Diagnosed psychiatric illness (severe depression, psychosis) or receiving&#xD;
               antipsychotic treatment&#xD;
  &#xD;
            -  Acrophobia&#xD;
  &#xD;
            -  Claustrophobia&#xD;
  &#xD;
            -  Photophobia&#xD;
  &#xD;
            -  Hearing loss&#xD;
  &#xD;
            -  Visual impairment&#xD;
  &#xD;
            -  Subject under guardianship or curatorship&#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_contact>
      <last_name>Capucine MORELOT-PANZINI</last_name>
      <phone>01 42 16 77 71</phone>
      <email>capucine.morelot@aphp.fr</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Thomas SIMILOWSKI</last_name>
      <phone>01 42 16 78 84</phone>
      <email>thomas.similowski@aphp.fr</email>
    </overall_contact_backup>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 25, 2023</study_first_submitted>
    <study_first_submitted_qc>August 25, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 1, 2023</study_first_posted>
    <last_update_submitted>August 25, 2023</last_update_submitted>
    <last_update_submitted_qc>August 25, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 1, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Persistent Dyspnea</keyword>
    <keyword>Non-Invasive Ventilation</keyword>
    <keyword>Immersive Virtual Reality</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Dyspnea</mesh_term>
      <mesh_term>Motor Neuron Disease</mesh_term>
      <mesh_term>Amyotrophic Lateral Sclerosis</mesh_term>
      <mesh_term>Sclerosis</mesh_term>
    </condition_browse>
    <!-- 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/NCT06021938
  org study id: APHP230974
  nct id: NCT06021938
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The evolution of amyotrophic lateral sclerosis (ALS) is marked by dyspnea, anxiety and pain,
        major determinants of suffering induced by this disease. The only palliative treatment for
        respiratory failure is non-invasive ventilation (NIV), which compensates failing respiratory
        muscles and relieves dyspnea, improves quality of life and increases life expectancy. In ALS
        patients, the persistence of dyspnea outside of NIV sessions has highlighted the need for
        therapeutic alternatives in the treatment of persistent dyspnea, including immersive virtual
        reality (IVR) and auditory distraction through music (music therapy). This study evaluates
        the effect of IVR on respiratory discomfort in ALS patients with persistent dyspnea treated
        with NIV.
  The evolution of amyotrophic lateral sclerosis (ALS) is marked by dyspnea, anxiety and pain,
        major determinants of suffering induced by this disease. The only palliative treatment for
        respiratory failure is non-invasive ventilation (NIV), which compensates failing respiratory
        muscles and relieves dyspnea, improves quality of life and increases life expectancy. In ALS
        patients, the persistence of dyspnea outside of NIV sessions has highlighted the need for
        therapeutic alternatives in the treatment of persistent dyspnea, including immersive virtual
        reality (IVR) and auditory distraction through music (music therapy). The objective of this
        study is to evaluate the effect of IVR on respiratory discomfort (scale A1 of the
        Multidimensional Dyspnea Profile (MDP) questionnaire) of patients with ALS at the stage of
        respiratory failure treated with NIV. This will be an open-label, monocentric, randomized,
        controlled cross-over clinical study. ALS patients will be recruited during their respiratory
        evaluation carried out as part of their usual care provided in an ambulatory setting (day
        care hospital) in the Pneumology Department of Pitié Salpêtrière Hospital. Eligibility
        criteria will be verified during this visit. If the patient meets eligibility criteria, the
        investigator will present the study to him using the information letter. After a period of
        reflection that the patient deems necessary to make his decision and after having obtained an
        answer to all his questions, his written consent will be collected by the investigator. The
        patient will then be offered a digital therapy session based on immersive virtual reality
        (IVR) and a music therapy session, 60 minutes apart. The IVR session will be based on medical
        hypnosis (GAMIDA®) and the music therapy session will be based on the choice of music that
        the patient wishes. Each session will last 15 minutes. Patients will start either with the
        medical hypnosis session by IVR or with the music session depending on the randomization
        carried out before the start of the study. The random order will be provided by software
        (CleanWeb).
  allocation: Randomized
  intervention model: Crossover Assignment
  primary purpose: Supportive Care
  masking: None (Open Label)
  measure: Evaluate the effect of IVR on respiratory discomfort (A1)
  time frame: 15 minutes
  description: Evaluate the effect of IVR on respiratory discomfort (scale A1 of the MDP questionnaire) of patients with ALS at the stage of respiratory failure treated with NIV
  measure: Evaluate the effect of IVR on respiratory discomfort (QS and A2)
  time frame: 15 minutes
  description: Evaluate the effect of IVR on the sensory (scale QS of the MDP questionnaire) and emotional (scale A2 of the MDP questionnaire) components of dyspnea of patients with ALS at the stage of respiratory failure treated with NIV.
  measure: Evaluate the effect of music therapy on respiratory discomfort (QS, A1 and A2)
  time frame: 15 minutes
  description: Evaluate the effect of music therapy on the sensory (scale QS of the MDP questionnaire), affective (scale A1 of the MDP questionnaire) and emotional (scale A2 of the MDP questionnaire) components of dyspnea of patients with ALS at the stage of respiratory failure treated with NIV.
  measure: Compare the evolutionary profile on respiratory discomfort (QS, A1 and A2) under the effect of IVR and music therapy
  time frame: 15 minutes
  description: Compare the evolutionary profile of the sensory ( scale QS of the MDP questionnaire ) and affective ( scale A1 and A2 of the MDP questionnaire) components of dyspnea under the effect of IVR and music therapy.
  measure: Compare the effect of IVR and music therapy on the respiratory discomfort in terms of preference.
  time frame: 15 minutes
  description: Compare the effect of IVR and music therapy on the respiratory discomfort of ALS patients treated with NIV in terms of preference through a post-exposure questionnaire after the two interventions
  measure: Evaluate the acceptability of IVR
  time frame: 15 minutes
  description: Evaluate the effect of IVR on dyspnea in terms of acceptability by a subjective questionnaire of six questions using a 7-point Likert scale.
  arm group label: Patients starting with RVI
  arm group type: Active Comparator
  description: Patients will begin by wear a virtual reality headset (GAMIDA®) and headphones (Bose®). A tablet (Samsung®) equipped with "Healthy Mind" software will allow patients to live a 360° visual and auditory 3D experience via Bluetooth connection. After that patients will be handed a smartphone with the Spotify® application to listen to music. Patients will wear headphones.
  arm group label: Patients starting with music therapy
  arm group type: Active Comparator
  description: Patients will begin by handed a smartphone with the Spotify® application to listen to music. Patients will wear headphones. After that patients will wear a virtual reality headset (GAMIDA®) and headphones (Bose®). A tablet (Samsung®) equipped with "Healthy Mind" software will allow patients to live a 360° visual and auditory 3D experience via Bluetooth connection.
  intervention type: Device
  intervention name: Immersive virtual reality (IVR) & Music therapy
  description: The patient will be offered a digital therapy session based on immersive virtual reality (IVR) and a music therapy session, 60 minutes apart. The IVR session will be based on medical hypnosis (GAMIDA®) and the music therapy session will be based on the choice of music the patient wishes. Each session will last 15 minutes. Patients will start either with the medical hypnosis session by IVR or with the music session depending on the randomization carried out before the start of the study. The random order will be provided by software (CleanWeb).
  arm group label: Patients starting with RVI
  arm group label: Patients starting with music therapy
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Capucine MORELOT-PANZINI
  phone: 01 42 16 77 71
  email: capucine.morelot@aphp.fr
  last name: Thomas SIMILOWSKI
  phone: 01 42 16 78 84
  email: thomas.similowski@aphp.fr
  responsible party type: Sponsor
  mesh term: Dyspnea
  mesh term: Motor Neuron Disease
  mesh term: Amyotrophic Lateral Sclerosis
  mesh term: Sclerosis