<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/NCT03274505</url>
  </required_header>
  <id_info>
    <org_study_id>69HCL17_0418</org_study_id>
    <nct_id>NCT03274505</nct_id>
  </id_info>
  <brief_title>Sleep Disorders in Transient Ischemic Attack and Stroke: SOMN'AIC Study</brief_title>
  <acronym>SOMN'AIC</acronym>
  <official_title>Comparison of the Prevalence of Sleep Disorders in Transient Ischemic Attack and Stroke</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hospices Civils de Lyon</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Hospices Civils de Lyon</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>
      Sleep disorders in the setting of stroke are numerous, including sleep-related breathing&#xD;
      disorders, insomnia, excessive daytime sleepiness and restless legs syndrome. Consequences of&#xD;
      theses sleep disturbances include impaired functional outcome and quality of life, anxious&#xD;
      and depressive troubles and increased cardio-vascular morbi-mortality. Mechanisms underlying&#xD;
      sleep disorders in the setting of stroke are complex and still partly elucidated. They&#xD;
      probably involve the consequences of the ischemic lesion and of the handicap, but also of&#xD;
      associated vascular risk factors and more generally pre-existent medical history, or they&#xD;
      could represent themselves a risk factor for stroke. Transient ischemic attack (TIA) is a&#xD;
      particular condition in which risk factors and background of patients are similar to that&#xD;
      observed in stroke, without any cerebral lesion and no persistent neurological deficit. The&#xD;
      main objective of the SOMN'AIC study is to compare the prevalence of sleep disorders in&#xD;
      stroke and in transient ischemic attack (TIA). The study hypothesis is that the prevalence of&#xD;
      sleep disorders may be higher in stroke than in TIA patients, reflecting the consequences of&#xD;
      the lesion and the associated handicap.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">November 14, 2017</start_date>
  <completion_date type="Anticipated">August 14, 2023</completion_date>
  <primary_completion_date type="Anticipated">November 14, 2022</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Comparison of stroke and transient ischemic attack population regarding the prevalence of the presence of at least one sleep disorder</measure>
    <time_frame>Maximum 9 months</time_frame>
    <description>Presence of at least one of the following sleep disorders assessed by clinical evaluation, questionnaires +/- polysomnography: insomnia, excessive daytime sleepiness (EDS), restless legs syndrome (RLS) and sleep apnoea syndrome (SAS)</description>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">200</enrollment>
  <condition>Sleep Disorder</condition>
  <condition>Stroke</condition>
  <arm_group>
    <arm_group_label>Stroke patients</arm_group_label>
    <description>Patients seen by a rehabilitation physician at a routine 3 months' post-stroke examination</description>
  </arm_group>
  <arm_group>
    <arm_group_label>TIA patients</arm_group_label>
    <description>Patients seen by a stroke specialist at the &quot;SOS TIA&quot; examination</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Questionnaires</intervention_name>
    <description>Questionnaires about excessive daytime sleepiness (Epworth scale), insomnia (Severity of Insomnia Scale), Restless Legs Syndrome, Chronotype (Horne and Ostberg questionnaire), Sleep apnoea syndrome (Berlin questionnaire)&#xD;
Clinical evaluation&#xD;
Routine neuropsychological evaluation (for stroke patients)&#xD;
Routine Polysomnography for patients with high suspicion of sleep apnoea syndrome (SOS score (Epworth + Berlin) &gt; 10)</description>
    <arm_group_label>Stroke patients</arm_group_label>
    <arm_group_label>TIA patients</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Stroke and transient ischemic attack patients&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Stroke group: patients with a diagnosis of stoke and seen at the routine post-stroke 3&#xD;
             month' rehabilitation examination&#xD;
&#xD;
          -  TIA group: diagnosis of a TIA by a stroke specialist at the &quot;SOS TIA&quot; examination&#xD;
&#xD;
          -  &gt; 18 years&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Refusal to participate&#xD;
&#xD;
          -  Severe cognitive impairment leading to inability to fulfil questionnaires&#xD;
&#xD;
          -  For the TIA group: presence of an ischemic lesion on CT scan or MRI&#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>Laure PETER-DEREX, MD, PhD</last_name>
    <phone>04 72 07 17 69</phone>
    <phone_ext>+33</phone_ext>
    <email>laure.peter-derex@chu-lyon.fr</email>
  </overall_contact>
  <location>
    <facility>
      <name>Service de Neurologie Vasculaire Groupement Hospitalier Est</name>
      <address>
        <city>Bron</city>
        <zip>69477</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <investigator>
      <last_name>Laurent Derex, PH</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Elodie Ong, PH</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Sleep Medicine Center, Croix-Rousse Hospital, Hospices Civils de Lyon</name>
      <address>
        <city>Lyon</city>
        <zip>69004</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>Service de MPR- Hôpital Henry Gabrielle - Groupement Sud</name>
      <address>
        <city>Saint-Genis-Laval</city>
        <zip>69230</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <investigator>
      <last_name>Jacques Luauté, PU-PH</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Sophie Jacquin Courtois, PU-PH</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Maxime Cheminon, PH</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Laure Huchon, PH</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>November 2021</verification_date>
  <study_first_submitted>September 5, 2017</study_first_submitted>
  <study_first_submitted_qc>September 5, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 7, 2017</study_first_posted>
  <last_update_submitted>November 15, 2021</last_update_submitted>
  <last_update_submitted_qc>November 15, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">November 16, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Stroke</mesh_term>
    <mesh_term>Sleep Wake Disorders</mesh_term>
    <mesh_term>Parasomnias</mesh_term>
    <mesh_term>Ischemic Attack, Transient</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/NCT03274505
org study id: 69HCL17_0418
nct id: NCT03274505
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Sleep disorders in the setting of stroke are numerous, including sleep-related breathing
      disorders, insomnia, excessive daytime sleepiness and restless legs syndrome. Consequences of
      theses sleep disturbances include impaired functional outcome and quality of life, anxious
      and depressive troubles and increased cardio-vascular morbi-mortality. Mechanisms underlying
      sleep disorders in the setting of stroke are complex and still partly elucidated. They
      probably involve the consequences of the ischemic lesion and of the handicap, but also of
      associated vascular risk factors and more generally pre-existent medical history, or they
      could represent themselves a risk factor for stroke. Transient ischemic attack (TIA) is a
      particular condition in which risk factors and background of patients are similar to that
      observed in stroke, without any cerebral lesion and no persistent neurological deficit. The
      main objective of the SOMN'AIC study is to compare the prevalence of sleep disorders in
      stroke and in transient ischemic attack (TIA). The study hypothesis is that the prevalence of
      sleep disorders may be higher in stroke than in TIA patients, reflecting the consequences of
      the lesion and the associated handicap.
observational model: Cohort
time perspective: Cross-Sectional
measure: Comparison of stroke and transient ischemic attack population regarding the prevalence of the presence of at least one sleep disorder
time frame: Maximum 9 months
description: Presence of at least one of the following sleep disorders assessed by clinical evaluation, questionnaires +/- polysomnography: insomnia, excessive daytime sleepiness (EDS), restless legs syndrome (RLS) and sleep apnoea syndrome (SAS)
arm group label: Stroke patients
description: Patients seen by a rehabilitation physician at a routine 3 months' post-stroke examination
arm group label: TIA patients
description: Patients seen by a stroke specialist at the "SOS TIA" examination
intervention type: Other
intervention name: Questionnaires
description: Questionnaires about excessive daytime sleepiness (Epworth scale), insomnia (Severity of Insomnia Scale), Restless Legs Syndrome, Chronotype (Horne and Ostberg questionnaire), Sleep apnoea syndrome (Berlin questionnaire)
Clinical evaluation
Routine neuropsychological evaluation (for stroke patients)
Routine Polysomnography for patients with high suspicion of sleep apnoea syndrome (SOS score (Epworth + Berlin) > 10)
arm group label: Stroke patients
arm group label: TIA patients
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Laure PETER-DEREX, MD, PhD
phone: 04 72 07 17 69
phone ext: +33
email: laure.peter-derex@chu-lyon.fr
facility: 
status: Recruiting
investigator: 
investigator: 
facility: 
status: Active, not recruiting
facility: 
status: Recruiting
investigator: 
investigator: 
investigator: 
investigator: 
country: France
responsible party type: Sponsor
mesh term: Stroke
mesh term: Sleep Wake Disorders
mesh term: Parasomnias
mesh term: Ischemic Attack, Transient
sharing ipd: No