<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/NCT04471168</url>
  </required_header>
  <id_info>
    <org_study_id>2018_0107</org_study_id>
    <nct_id>NCT04471168</nct_id>
  </id_info>
  <brief_title>Interest of Auriculotherapy in the Management of Chronic Insomnia</brief_title>
  <acronym>AURICULO-DODO</acronym>
  <official_title>Interest of Auriculotherapy in the Management of Chronic Insomnia</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hopital Foch</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Hopital Foch</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 aim of the study is to show that auriculotherapy is effective in the treatment of chronic&#xD;
      insomnia.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Chronic insomnia affects a significant proportion of the French population with an estimated&#xD;
      prevalence between 15% and 20%.&#xD;
&#xD;
      This disease is mainly managed by general practitioners for whom benzodiazepines and Z-drugs&#xD;
      (zopiclone, zolpidem) represent the first-line treatment. The french health authorities&#xD;
      recommend limiting the consumption of these molecules to 2 to 4 weeks taking into account&#xD;
      their possible undesirable effects (eg memory impairment, in the elderly, road accident) as&#xD;
      well as the risk of tolerance and addiction. However, it appears that a majority of the&#xD;
      patients concerned become chronic consumers.&#xD;
&#xD;
      The investigators propose to assess cryo-auriculotherapy in the treatment of chronic&#xD;
      insomnia.&#xD;
&#xD;
      The population studied will consist of patients with chronic insomnia, whose diagnosis has&#xD;
      been made according to the definition in the diagnostic and statistical manual of mental&#xD;
      disorders (DSM-5), and followed up in an outpatient clinic at Foch Hospital or in one of the&#xD;
      participating centers.&#xD;
&#xD;
      Half of the patients will be treated with cryo-auriculotherapy (use of a device with nitrous&#xD;
      oxide) and compared with control patients who will have the same treatment visits involving a&#xD;
      sham device (device without nitrous oxide).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">October 14, 2020</start_date>
  <completion_date type="Anticipated">October 2023</completion_date>
  <primary_completion_date type="Anticipated">October 2023</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 (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of patients with improvement of insomnia after 3 month of treatment (Real Auriculotherapy group compared to Sham Auriculotherapy group)</measure>
    <time_frame>3 months</time_frame>
    <description>Comparison of the evolution of the score of the Insomnia Severity Index (7-item self-report questionnaire assessing the nature, severity, and impact of insomnia).&#xD;
Total score categories:&#xD;
0-7 = No clinically significant insomnia 8-14 = Subthreshold insomnia 15-21 = Clinical insomnia (moderate severity) 22-28 = Clinical insomnia (severe)&#xD;
The improvement will be defined as a decrease in the score of the questionnaire by 3 points between Day 90 and Day 0.&#xD;
A comparison of the improvement according to the 2 arms will be made.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Evolution of sleep quality and sleep disorders</measure>
    <time_frame>3 months</time_frame>
    <description>Specific questionnaire Pittsburgh Sleep Quality Index (PSQI)at inclusion and at 3 months (1 month post-treatment).&#xD;
Seven component scores are derived, each scored 0 (no difficulty) to 3 (severe difficulty). The component scores are summed to produce a global score (range 0 to 21).&#xD;
Higher scores indicate worse sleep quality.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evolution of drug consumption linked to chronic insomnia</measure>
    <time_frame>3 months</time_frame>
    <description>Drugs used to control chronic insomnia will be collected from the inclusion to 3 months (1 month post-treatment)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evolution and Anxiety and depression</measure>
    <time_frame>3 months</time_frame>
    <description>Hospital Anxiety and Depression questionnaire will be used at inclusion and at 3 months post-treatment.&#xD;
There are seven questions related to anxiety (total A) and seven others related to the depressive dimension (total D), allowing thus obtaining two scores (maximum score of each score = 21).&#xD;
Higher score indicates a certain symptomatology :&#xD;
7 or less: absence of symptoms&#xD;
8 to 10: doubtful symptomatology&#xD;
11 and more: certain symptomatology.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evolution of quality of life</measure>
    <time_frame>3 months</time_frame>
    <description>EuroQoL five Dimension questionnaire at inclusion and at 3 months post-treatment. This questionnaire is designed for the patient to judge the impact of his state of health on his quality of life according to 5 dimensions (mobility, personal autonomy, daily activities, pain / discomfort and anxiety / depression). Each item has 3 response levels (1, 2 and 3) and the combination of the five digits will represent the patient's state of health. It is supplemented by a quality of life thermometer graduated from 0 (worst quality of life) to 100 (best quality of life).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall patient impression</measure>
    <time_frame>3 months</time_frame>
    <description>Patient Global Impression of Change questionnaire (PGIC) used at the end of the follow-up.&#xD;
This scale evaluates all aspects of patients' health and assesses if there has been an improvement or decline in clinical status with a seven-point single-item scale ranging from 'very much worse' to 'very much improved'</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Willingness of the patient to continue treatment</measure>
    <time_frame>3 months</time_frame>
    <description>Patient will be asked at the end of the study if they want to pursue the treatment</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Tolerance of cryotherapy auriculotherapy treatment.</measure>
    <time_frame>3 months</time_frame>
    <description>The presence or absence of adverse events attributed to the treatment of auriculotherapy by the patient.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">72</enrollment>
  <condition>Chronic Insomnia</condition>
  <arm_group>
    <arm_group_label>Cryo-Auriculotherapy</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients benefit from 3 sessions of cryo-auriculotherapy with device with nitrous oxyde on 10 auricular points at one month intervals.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control group</arm_group_label>
    <arm_group_type>Sham Comparator</arm_group_type>
    <description>Patients benefit from 3 sessions of cryo-auriculotherapy with device without nitrous oxyde on 10 auricular points at one month intervals.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Cryo-Auriculotherapy</intervention_name>
    <description>3 sessions of cryo-auriculotherapy with device with nitrous oxyde on 10 auricular points at one month intervals.</description>
    <arm_group_label>Cryo-Auriculotherapy</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Sham comparator</intervention_name>
    <description>3 sessions of cryo-auriculotherapy with device without nitrous oxyde on 10 auricular points at one month intervals.</description>
    <arm_group_label>Control group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Suffering from chronic insomnia as defined in the diagnostic and statistical manual of&#xD;
             mental disorders (DSM-5)&#xD;
&#xD;
          -  Score ≥ 15 on the Insomnia Severity Index (ISI) questionnaire;&#xD;
&#xD;
          -  Covered by a national healthcare insurance&#xD;
&#xD;
          -  Consent form signed&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pregnant woman or pregnancy planned for the duration of the study;&#xD;
&#xD;
          -  Regular night work or shift work / reversal of sleep patterns;&#xD;
&#xD;
          -  Trans meridian travel during the previous month or planned during the study period;&#xD;
&#xD;
          -  Unstable or untreated psychiatric disorder including severe depression, severe&#xD;
             addiction, unbalanced bipolar disorder;&#xD;
&#xD;
          -  Taking insomnia-inducing drugs (eg Corticoids);&#xD;
&#xD;
          -  Hypnotic treatment or antidepressant treatment with hypnotic aim introduced since less&#xD;
             than 4 weeks or with change dating back less than 4 weeks;&#xD;
&#xD;
          -  Presence of organic comorbidities which may be responsible for sleep disorders (SAS&#xD;
             and restless legs syndrome): (STOP-BANG) score ≥ 5;&#xD;
&#xD;
          -  History of central neurological disorders or progressive brain injury;&#xD;
&#xD;
          -  Contraindication to the use of auriculotherapy (lesion or infection of the pinna) by&#xD;
             cryotherapy (skin scarring disorder, risk of hypo or hyperpigmentation);&#xD;
&#xD;
          -  Treatment by auriculotherapy or acupuncture in this indication in the previous 12&#xD;
             months;&#xD;
&#xD;
          -  Previous treatment with cryo-auriculotherapy&#xD;
&#xD;
          -  Having started in the month preceding the first auriculotherapy session, any new&#xD;
             treatment likely to interfere with the study: specific drug treatment (antidepressant,&#xD;
             morphine or anticonvulsant) or complementary therapy (psychological care,&#xD;
             physiotherapy, balneotherapy, etc.).&#xD;
&#xD;
          -  Difficulty complying with the treatment, questionnaire or study protocol.&#xD;
&#xD;
          -  Be deprived of liberty or under guardianship.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>64 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Mireille Michel-Cherqui, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Hopital Foch</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Mireille Michel-Cherqui, MD</last_name>
    <phone>+33(0)146252985</phone>
    <email>m.michel-cherqui@hopital-foch.org</email>
  </overall_contact>
  <location>
    <facility>
      <name>Espace Santé Simone Veil</name>
      <address>
        <city>Issy-les-Moulineaux</city>
        <state>Hauts De Seine</state>
        <zip>97132</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Sabrina MA, MD</last_name>
      <email>sabrina.ma@ville-issy.fr</email>
    </contact>
    <investigator>
      <last_name>Sabrina MA, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Cabinet Médical Nouvelle France</name>
      <address>
        <city>Le Chesnay</city>
        <state>Yvelines</state>
        <zip>78158</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>Cabinet de l'Olivier</name>
      <address>
        <city>Montigny-le-Bretonneux</city>
        <state>Yvelines</state>
        <zip>78423</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>Hopital Foch</name>
      <address>
        <city>Suresnes</city>
        <zip>92150</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Mireille Michel-Cherqui, MD</last_name>
      <phone>+33(0)146252985</phone>
      <email>m.michel-cherqui@hopital-foch.org</email>
    </contact>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>June 2023</verification_date>
  <study_first_submitted>June 10, 2020</study_first_submitted>
  <study_first_submitted_qc>July 9, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 15, 2020</study_first_posted>
  <last_update_submitted>June 13, 2023</last_update_submitted>
  <last_update_submitted_qc>June 13, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">June 15, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Cryo auriculotherapy</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Sleep Initiation and Maintenance Disorders</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</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/NCT04471168
org study id: 2018_0107
nct id: NCT04471168
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The aim of the study is to show that auriculotherapy is effective in the treatment of chronic
      insomnia.
Chronic insomnia affects a significant proportion of the French population with an estimated
      prevalence between 15% and 20%.

      This disease is mainly managed by general practitioners for whom benzodiazepines and Z-drugs
      (zopiclone, zolpidem) represent the first-line treatment. The french health authorities
      recommend limiting the consumption of these molecules to 2 to 4 weeks taking into account
      their possible undesirable effects (eg memory impairment, in the elderly, road accident) as
      well as the risk of tolerance and addiction. However, it appears that a majority of the
      patients concerned become chronic consumers.

      The investigators propose to assess cryo-auriculotherapy in the treatment of chronic
      insomnia.

      The population studied will consist of patients with chronic insomnia, whose diagnosis has
      been made according to the definition in the diagnostic and statistical manual of mental
      disorders (DSM-5), and followed up in an outpatient clinic at Foch Hospital or in one of the
      participating centers.

      Half of the patients will be treated with cryo-auriculotherapy (use of a device with nitrous
      oxide) and compared with control patients who will have the same treatment visits involving a
      sham device (device without nitrous oxide).
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Participant)
measure: Number of patients with improvement of insomnia after 3 month of treatment (Real Auriculotherapy group compared to Sham Auriculotherapy group)
time frame: 3 months
description: Comparison of the evolution of the score of the Insomnia Severity Index (7-item self-report questionnaire assessing the nature, severity, and impact of insomnia).
Total score categories:
0-7 = No clinically significant insomnia 8-14 = Subthreshold insomnia 15-21 = Clinical insomnia (moderate severity) 22-28 = Clinical insomnia (severe)
The improvement will be defined as a decrease in the score of the questionnaire by 3 points between Day 90 and Day 0.
A comparison of the improvement according to the 2 arms will be made.
measure: Evolution of sleep quality and sleep disorders
time frame: 3 months
description: Specific questionnaire Pittsburgh Sleep Quality Index (PSQI)at inclusion and at 3 months (1 month post-treatment).
Seven component scores are derived, each scored 0 (no difficulty) to 3 (severe difficulty). The component scores are summed to produce a global score (range 0 to 21).
Higher scores indicate worse sleep quality.
measure: Evolution of drug consumption linked to chronic insomnia
time frame: 3 months
description: Drugs used to control chronic insomnia will be collected from the inclusion to 3 months (1 month post-treatment)
measure: Evolution and Anxiety and depression
time frame: 3 months
description: Hospital Anxiety and Depression questionnaire will be used at inclusion and at 3 months post-treatment.
There are seven questions related to anxiety (total A) and seven others related to the depressive dimension (total D), allowing thus obtaining two scores (maximum score of each score = 21).
Higher score indicates a certain symptomatology :
7 or less: absence of symptoms
8 to 10: doubtful symptomatology
11 and more: certain symptomatology.
measure: Evolution of quality of life
time frame: 3 months
description: EuroQoL five Dimension questionnaire at inclusion and at 3 months post-treatment. This questionnaire is designed for the patient to judge the impact of his state of health on his quality of life according to 5 dimensions (mobility, personal autonomy, daily activities, pain / discomfort and anxiety / depression). Each item has 3 response levels (1, 2 and 3) and the combination of the five digits will represent the patient's state of health. It is supplemented by a quality of life thermometer graduated from 0 (worst quality of life) to 100 (best quality of life).
measure: Overall patient impression
time frame: 3 months
description: Patient Global Impression of Change questionnaire (PGIC) used at the end of the follow-up.
This scale evaluates all aspects of patients' health and assesses if there has been an improvement or decline in clinical status with a seven-point single-item scale ranging from 'very much worse' to 'very much improved'
measure: Willingness of the patient to continue treatment
time frame: 3 months
description: Patient will be asked at the end of the study if they want to pursue the treatment
measure: Tolerance of cryotherapy auriculotherapy treatment.
time frame: 3 months
description: The presence or absence of adverse events attributed to the treatment of auriculotherapy by the patient.
arm group label: Cryo-Auriculotherapy
arm group type: Experimental
description: Patients benefit from 3 sessions of cryo-auriculotherapy with device with nitrous oxyde on 10 auricular points at one month intervals.
arm group label: Control group
arm group type: Sham Comparator
description: Patients benefit from 3 sessions of cryo-auriculotherapy with device without nitrous oxyde on 10 auricular points at one month intervals.
intervention type: Device
intervention name: Cryo-Auriculotherapy
description: 3 sessions of cryo-auriculotherapy with device with nitrous oxyde on 10 auricular points at one month intervals.
arm group label: Cryo-Auriculotherapy
intervention type: Device
intervention name: Sham comparator
description: 3 sessions of cryo-auriculotherapy with device without nitrous oxyde on 10 auricular points at one month intervals.
arm group label: Control group
criteria: 
gender: All
minimum age: 18 Years
maximum age: 64 Years
healthy volunteers: No
last name: Mireille Michel-Cherqui, MD
role: Principal Investigator
affiliation: Hopital Foch
last name: Mireille Michel-Cherqui, MD
phone: +33(0)146252985
email: m.michel-cherqui@hopital-foch.org
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Active, not recruiting
facility: 
status: Active, not recruiting
facility: 
status: Recruiting
contact: 
country: France
responsible party type: Sponsor
mesh term: Sleep Initiation and Maintenance Disorders
sharing ipd: No