<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/NCT03793699</url>
  </required_header>
  <id_info>
    <org_study_id>2017_55</org_study_id>
    <secondary_id>2017-A03649-44</secondary_id>
    <nct_id>NCT03793699</nct_id>
  </id_info>
  <brief_title>Evaluation of the Links Between Sleep Disorders and the Risk of Suicide Attempt</brief_title>
  <acronym>HYPNOS</acronym>
  <official_title>Evaluation of the Links Between Sleep Disorders and the Risk of Suicide Attempt</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Lille</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Hospital, Lille</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>
      Several studies have demonstrated an association between sleep disorders such as insomnia and&#xD;
      nightmares to suicidal ideations and behaviors.&#xD;
&#xD;
      Nevertheless, some of these studies are methodologically questionable especially in the&#xD;
      exploration of sleep disorders. Furthermore, confounding factors such as depressive&#xD;
      symptomatology are not controlled and the measurement of suicidal behavior has often been&#xD;
      taken into account as a historical measure, not as a current event, which introduces&#xD;
      uncertainties and a lack of precision regarding the temporality of the phenomena.&#xD;
&#xD;
      Today, while the links between sleep disorders and suicidal risk are well known, we have a&#xD;
      lack of information on the importance and the role of sleep disorders as a precipitating&#xD;
      factor. Indeed, few studies have evaluated the temporal link between sleep disorders and&#xD;
      suicidal acts.&#xD;
&#xD;
      The objective of this study is to evaluate the links between acute and chronic sleep&#xD;
      disorders and the risk of suicide attempt&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Pilot, prospective, monocentric case-control study.&#xD;
&#xD;
      There are 2 groups of subjects :&#xD;
&#xD;
        -  group of patients who have made a suicide attempt&#xD;
&#xD;
        -  control group with only suicidal ideas&#xD;
&#xD;
      First visit V1 is performed within the first 72 hours of hospitalization. A re-assessment is&#xD;
      scheduled 1 month after (V2).&#xD;
&#xD;
      At V1, collected parameters are : chronic sleep disorders, chronotype, specific sleep&#xD;
      disorders in posttraumatic stress disorder, nightmares and the distress associated, childhood&#xD;
      trauma, cognitive dysfunction, suicidal ideation and psychopathologic assessment.&#xD;
&#xD;
      At V2, we assess evolution of sleep disturbances and suicidal ideation.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">February 4, 2019</start_date>
  <completion_date type="Anticipated">December 2022</completion_date>
  <primary_completion_date type="Anticipated">December 2022</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Sleep disorders intensity by the Insomnia Severity Index (ISI)</measure>
    <time_frame>at the 48 hours after the hospitalization; at the maximum within 72 hours.</time_frame>
    <description>ISI score in the last 2 weeks between a group of suicide attempts and a group with suicidal thoughts suicidal The Insomnia Severity Index has seven questions. The seven answers are added up to get a total score.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Correlation between Beck Suicide Intent Scale (BSIS) score and ISI score</measure>
    <time_frame>Baseline (visit inclusion) and at one month ago</time_frame>
    <description>Correlation between Beck Suicide Intent Scale (BSIS) score and ISI score The Suicide Intent Scale (SIS) wconsists of 15 questions which are scaled from 0-2, which take into account both the logistics of the suicide attempt as well as the intent. The scale has high reliability and validity. Completed suicides ranked higher in the severity of the logistics than attempted suicides (it was impossible to measure intent for the completed suicides), and those with multiple attempts had higher scores than those who only attempted suicide once</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evolution of ISI score</measure>
    <time_frame>At one month +/- 15 days ant at 3 months +/-3 weeks</time_frame>
    <description>Assess the evolution of sleep disturbances for each group by ISI Score</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Chronotype classification by MCTQ</measure>
    <time_frame>at the 48 hours after the hospitalization; at the maximum within 72 hours;at 3 months +/-3 weeks</time_frame>
    <description>Exploratory descriptive measures in the 2 groups</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pittsburg Sleep Quality Index (PSQI) score</measure>
    <time_frame>at the 48 hours after the hospitalization; at the maximum within 72 hours,at 3 months +/-3 weeks</time_frame>
    <description>PSQI score between the groups PSQI is a self-report questionnaire that assesses sleep quality over a 1-month time interval. The measure consists of 19 individual items, creating 7 components that produce one global score, and takes 5-10 minutes to complete.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Childhood Trauma Questionnaire (CTQ) score</measure>
    <time_frame>at the 48 hours after the hospitalization; at the maximum within 72 hours.</time_frame>
    <description>CTQ score between the groups The Childhood Trauma Questionnaire was developed as a screening tool for histories of abut and neglect. The self-report includes a 28-item test that measures 5 types of maltreatment - emotional, physical, and sexual abuse, and emotional and physical neglect.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Montréal Cognitive Assessment (MocA)</measure>
    <time_frame>at the 48 hours after the hospitalization; at the maximum within 72 hours.</time_frame>
    <description>cognitive assessment by Moca test</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">60</enrollment>
  <condition>Attempted Suicide</condition>
  <arm_group>
    <arm_group_label>case group : realized a suicide attempt</arm_group_label>
    <description>adults having realized a suicide attempt and without histories of suicide attempt.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>control group : only suicidal ideas</arm_group_label>
    <description>adults having suicidal ideas without suicidal acting out and without histories of suicide attempt.</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        The population in the study is a population of adults having realized a suicide attempt and&#xD;
        without histories of suicide attempt. She(it) will be compared with a population of adults&#xD;
        having suicidal ideas without suicidal acting out and without histories of suicide attempt.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria&#xD;
&#xD;
        Criterion specific to the studying group :&#xD;
&#xD;
        - Subjects hospitalized and whose indication of hospitalization is a suicide attempt by&#xD;
        voluntary drug intoxication or phlebotomy during the last 72 hours, without any history of&#xD;
        attempted suicide&#xD;
&#xD;
        Criterion specific to the control group:&#xD;
&#xD;
        - Subjects hospitalized since less than 72 hours, and whose indication of hospitalization&#xD;
        is the presence of suicidal ideas, without any history of attempted suicide&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pregnant of lactating women&#xD;
&#xD;
          -  Diagnosed dementia pathology&#xD;
&#xD;
          -  Proven intellectual disability&#xD;
&#xD;
          -  Patient whose physical or mental state does not allow the passing of the tests of the&#xD;
             study&#xD;
&#xD;
          -  Under protective measures (guardianship/supervision)&#xD;
&#xD;
          -  Refusal to participate in the study&#xD;
&#xD;
          -  Diagnosed with chronic or severe psychiatric illness (psychotic disorder, bipolarity)&#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>Vincent JARDON, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University Hospital, Lille</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Vincent JARDON, MD</last_name>
    <phone>320 44 45 84</phone>
    <phone_ext>+33</phone_ext>
    <email>vincent.jardon@chru-lille.fr</email>
  </overall_contact>
  <location>
    <facility>
      <name>Hôpital Fontan, CHU</name>
      <address>
        <city>Lille</city>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <investigator>
      <last_name>Vincent Jardon, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>September 2020</verification_date>
  <study_first_submitted>October 16, 2018</study_first_submitted>
  <study_first_submitted_qc>January 3, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 4, 2019</study_first_posted>
  <last_update_submitted>September 10, 2020</last_update_submitted>
  <last_update_submitted_qc>September 10, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">September 11, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Suicide</keyword>
  <keyword>Suicidal ideation</keyword>
  <keyword>Sleep disorder</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Sleep Wake Disorders</mesh_term>
    <mesh_term>Parasomnias</mesh_term>
    <mesh_term>Suicide</mesh_term>
    <mesh_term>Suicide, Attempted</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/NCT03793699
org study id: 2017_55
secondary id: 2017-A03649-44
nct id: NCT03793699
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Several studies have demonstrated an association between sleep disorders such as insomnia and
      nightmares to suicidal ideations and behaviors.

      Nevertheless, some of these studies are methodologically questionable especially in the
      exploration of sleep disorders. Furthermore, confounding factors such as depressive
      symptomatology are not controlled and the measurement of suicidal behavior has often been
      taken into account as a historical measure, not as a current event, which introduces
      uncertainties and a lack of precision regarding the temporality of the phenomena.

      Today, while the links between sleep disorders and suicidal risk are well known, we have a
      lack of information on the importance and the role of sleep disorders as a precipitating
      factor. Indeed, few studies have evaluated the temporal link between sleep disorders and
      suicidal acts.

      The objective of this study is to evaluate the links between acute and chronic sleep
      disorders and the risk of suicide attempt
Pilot, prospective, monocentric case-control study.

      There are 2 groups of subjects :

        -  group of patients who have made a suicide attempt

        -  control group with only suicidal ideas

      First visit V1 is performed within the first 72 hours of hospitalization. A re-assessment is
      scheduled 1 month after (V2).

      At V1, collected parameters are : chronic sleep disorders, chronotype, specific sleep
      disorders in posttraumatic stress disorder, nightmares and the distress associated, childhood
      trauma, cognitive dysfunction, suicidal ideation and psychopathologic assessment.

      At V2, we assess evolution of sleep disturbances and suicidal ideation.
observational model: Case-Control
time perspective: Prospective
measure: Sleep disorders intensity by the Insomnia Severity Index (ISI)
time frame: at the 48 hours after the hospitalization; at the maximum within 72 hours.
description: ISI score in the last 2 weeks between a group of suicide attempts and a group with suicidal thoughts suicidal The Insomnia Severity Index has seven questions. The seven answers are added up to get a total score.
measure: Correlation between Beck Suicide Intent Scale (BSIS) score and ISI score
time frame: Baseline (visit inclusion) and at one month ago
description: Correlation between Beck Suicide Intent Scale (BSIS) score and ISI score The Suicide Intent Scale (SIS) wconsists of 15 questions which are scaled from 0-2, which take into account both the logistics of the suicide attempt as well as the intent. The scale has high reliability and validity. Completed suicides ranked higher in the severity of the logistics than attempted suicides (it was impossible to measure intent for the completed suicides), and those with multiple attempts had higher scores than those who only attempted suicide once
measure: Evolution of ISI score
time frame: At one month +/- 15 days ant at 3 months +/-3 weeks
description: Assess the evolution of sleep disturbances for each group by ISI Score
measure: Chronotype classification by MCTQ
time frame: at the 48 hours after the hospitalization; at the maximum within 72 hours;at 3 months +/-3 weeks
description: Exploratory descriptive measures in the 2 groups
measure: Pittsburg Sleep Quality Index (PSQI) score
time frame: at the 48 hours after the hospitalization; at the maximum within 72 hours,at 3 months +/-3 weeks
description: PSQI score between the groups PSQI is a self-report questionnaire that assesses sleep quality over a 1-month time interval. The measure consists of 19 individual items, creating 7 components that produce one global score, and takes 5-10 minutes to complete.
measure: Childhood Trauma Questionnaire (CTQ) score
time frame: at the 48 hours after the hospitalization; at the maximum within 72 hours.
description: CTQ score between the groups The Childhood Trauma Questionnaire was developed as a screening tool for histories of abut and neglect. The self-report includes a 28-item test that measures 5 types of maltreatment - emotional, physical, and sexual abuse, and emotional and physical neglect.
measure: Montréal Cognitive Assessment (MocA)
time frame: at the 48 hours after the hospitalization; at the maximum within 72 hours.
description: cognitive assessment by Moca test
arm group label: case group : realized a suicide attempt
description: adults having realized a suicide attempt and without histories of suicide attempt.
arm group label: control group : only suicidal ideas
description: adults having suicidal ideas without suicidal acting out and without histories of suicide attempt.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Vincent JARDON, MD
role: Principal Investigator
affiliation: University Hospital, Lille
last name: Vincent JARDON, MD
phone: 320 44 45 84
phone ext: +33
email: vincent.jardon@chru-lille.fr
facility: 
status: Recruiting
investigator: 
country: France
responsible party type: Sponsor
mesh term: Sleep Wake Disorders
mesh term: Parasomnias
mesh term: Suicide
mesh term: Suicide, Attempted