<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/NCT04483310</url>
  </required_header>
  <id_info>
    <org_study_id>18090</org_study_id>
    <nct_id>NCT04483310</nct_id>
  </id_info>
  <brief_title>Meditation-Relaxation (MR Therapy) for Sleep Paralysis.</brief_title>
  <acronym>MR_Therapy</acronym>
  <official_title>Meditation-Relaxation (MR Therapy) for Sleep Paralysis: A Pilot Study in Patients With Narcolepsy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Azienda Usl di Bologna</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Azienda Usl di Bologna</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The aim of the study is to evaluate, with a small-scale pilot study, the efficacy of&#xD;
      Meditation Relaxation therapy for Sleep Paralyses in patients with narcolepsy. The study&#xD;
      involves two arms, with intervention with Meditation Relaxation therapy or sham over a period&#xD;
      of three months.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">December 1, 2018</start_date>
  <completion_date type="Anticipated">December 31, 2022</completion_date>
  <primary_completion_date type="Anticipated">December 31, 2022</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Sleep Paralysis Experiences and Phenomenology Questionnaire (SP-EPQ)</measure>
    <time_frame>Three months.</time_frame>
    <description>The questionnaire addresses the distress associated with SP.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Daily journal</measure>
    <time_frame>Three months.</time_frame>
    <description>Each day during the study (12 weeks), participants rated their SP occurrence, perceived duration (sec./min.), fear associated with SP, and disturbance caused by hallucinations (on a ten-point scale).</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">20</enrollment>
  <condition>Sleep Paralysis</condition>
  <condition>Narcolepsy Type 1</condition>
  <arm_group>
    <arm_group_label>MR therapy</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>MR therapy is a psychological treatment for SP, comprised of the following steps applied directly during the attack: Step I: Reappraisal of the meaning of the attack; Step II: psychological and emotional distancing; Step III: inward focused-attention meditation; Step IV: Muscle relaxation.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control intervention</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>The control intervention was identical, except participants engaged in deep breathing; entailing slow deep breaths, while repeatedly counting from 1-10. This is an active control (breathing-distraction exercise) rather than a placebo.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>MR therapy.</intervention_name>
    <description>MR therapy is based on 4 steps applied directly during the attack: Step I: Reappraisal of the meaning of the attack; Step II: psychological and emotional distancing; Step III: inward focused-attention meditation; Step IV: Muscle relaxation.</description>
    <arm_group_label>MR therapy</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>breathing-distraction exercise</intervention_name>
    <description>The control intervention is based on a breathing exercise, the patients should entail slow deep breaths, while repeatedly counting from 1-10</description>
    <arm_group_label>Control intervention</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Narcolepsy (type 1 and 2) based on polysomnography, Multiple Sleep Latency Test [MLST]&#xD;
             and CSF hypocretin level testing).&#xD;
&#xD;
          -  Patients had to have experienced SP at least four times in the last month.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Psychiatric comorbidity.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Azienda USL di Bologna</name>
      <address>
        <city>Bologna</city>
        <country>Italy</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Giuseppe Plazzi</last_name>
      <phone>0039 051 4966926</phone>
      <email>giuseppe.plazzi@unibo.it</email>
    </contact>
    <contact_backup>
      <last_name>Fabio Pizza</last_name>
      <phone>0039 051 4966924</phone>
      <email>fabio.pizza@unibo.it</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>Italy</country>
  </location_countries>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>July 3, 2020</study_first_submitted>
  <study_first_submitted_qc>July 22, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 23, 2020</study_first_posted>
  <last_update_submitted>July 22, 2020</last_update_submitted>
  <last_update_submitted_qc>July 22, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 23, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Behavioral Treatment</keyword>
  <keyword>Sleep Paralysis</keyword>
  <keyword>Narcolepsy Type 1</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Paralysis</mesh_term>
    <mesh_term>Narcolepsy</mesh_term>
    <mesh_term>Sleep Paralysis</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/NCT04483310
org study id: 18090
nct id: NCT04483310
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
The aim of the study is to evaluate, with a small-scale pilot study, the efficacy of
      Meditation Relaxation therapy for Sleep Paralyses in patients with narcolepsy. The study
      involves two arms, with intervention with Meditation Relaxation therapy or sham over a period
      of three months.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Sleep Paralysis Experiences and Phenomenology Questionnaire (SP-EPQ)
time frame: Three months.
description: The questionnaire addresses the distress associated with SP.
measure: Daily journal
time frame: Three months.
description: Each day during the study (12 weeks), participants rated their SP occurrence, perceived duration (sec./min.), fear associated with SP, and disturbance caused by hallucinations (on a ten-point scale).
arm group label: MR therapy
arm group type: Experimental
description: MR therapy is a psychological treatment for SP, comprised of the following steps applied directly during the attack: Step I: Reappraisal of the meaning of the attack; Step II: psychological and emotional distancing; Step III: inward focused-attention meditation; Step IV: Muscle relaxation.
arm group label: Control intervention
arm group type: Active Comparator
description: The control intervention was identical, except participants engaged in deep breathing; entailing slow deep breaths, while repeatedly counting from 1-10. This is an active control (breathing-distraction exercise) rather than a placebo.
intervention type: Behavioral
intervention name: MR therapy.
description: MR therapy is based on 4 steps applied directly during the attack: Step I: Reappraisal of the meaning of the attack; Step II: psychological and emotional distancing; Step III: inward focused-attention meditation; Step IV: Muscle relaxation.
arm group label: MR therapy
intervention type: Behavioral
intervention name: breathing-distraction exercise
description: The control intervention is based on a breathing exercise, the patients should entail slow deep breaths, while repeatedly counting from 1-10
arm group label: Control intervention
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
facility: 
status: Recruiting
contact: 
contact backup: 
country: Italy
responsible party type: Sponsor
mesh term: Paralysis
mesh term: Narcolepsy
mesh term: Sleep Paralysis