<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/NCT04413110</url>
  </required_header>
  <id_info>
    <org_study_id>Mansoura University migraine</org_study_id>
    <nct_id>NCT04413110</nct_id>
  </id_info>
  <brief_title>PSG and Neuroendocrine Hormones in Subjective Cognitive Impaired Patients With Transformed Migraine</brief_title>
  <official_title>PSG and Neuroendocrine Hormones in Subjective Cognitive Impaired Patients With Transformed Migraine</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Mansoura University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Mansoura University Hospital</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>
      Transformed migraine is the most common and challenging subtype of chronic daily headache&#xD;
      disorders35. Patients with transformed migraine often report an evolutionary process that&#xD;
      occurs over months or years in which headaches increase in frequency, change characteristics&#xD;
      and ultimately result in patterns of daily or near-daily headaches resembling a mixture of&#xD;
      tension-type headache and migraine.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The present study aimed to investigate the presence and frequency of cognitive affection in&#xD;
      patients with transformed migraines, as well as to analyze the association of cognitive&#xD;
      affection with clinical features and headache impact, anxiety, depression, and quality of&#xD;
      sleep.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">April 1, 2019</start_date>
  <completion_date type="Actual">April 1, 2020</completion_date>
  <primary_completion_date type="Actual">March 1, 2020</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>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Polysomnography</measure>
    <time_frame>24-72 hours</time_frame>
    <description>PSG was carried out for 41 patients with subjective cognitive impairment and 41 age and sex-matched controls. PSG with standard EEG montage that includes bilateral EOG and four EEG leads were used. A single attended overnight PSG study was performed at the Clinical Neurophysiology Unit of Mansoura University Hospitals. Patients were studied in a quiet, darkened room with no medications were used to induce sleep. All participants underwent one night of laboratory-based PSG.</description>
  </primary_outcome>
  <number_of_groups>3</number_of_groups>
  <enrollment type="Actual">161</enrollment>
  <condition>Migraine</condition>
  <arm_group>
    <arm_group_label>Non-subjective cognitive impaired</arm_group_label>
    <description>Cases of migraine and non-subjective cognitive impaired</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Subjective cognitive impaired</arm_group_label>
    <description>Cases of migraine and subjective cognitive impaired</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control group</arm_group_label>
    <description>Age and sex matched healthy controls</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Polysomnography</intervention_name>
    <description>PSG was carried out for 41 patients with subjective cognitive impairment and 41 age and sex-matched controls. PSG with standard EEG montage that includes bilateral EOG and four EEG leads were used. A single attended overnight PSG study was performed at the Clinical Neurophysiology Unit of Mansoura University Hospitals. Patients were studied in a quiet, darkened room with no medications were used to induce sleep. All participants underwent one night of laboratory-based PSG.</description>
    <arm_group_label>Control group</arm_group_label>
    <arm_group_label>Subjective cognitive impaired</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        The diagnosis of headache disorders was based on the International Classification of&#xD;
        Disease, Eleventh Revision (ICD-11). Patients included were adults with clinically&#xD;
        confirmed of chronic migraine, completion of cognitive testing and questionnaires, and&#xD;
        normal performance on cognitive tests based on normative data, stratified by gender, age,&#xD;
        and education level.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        -Patients included were adults with clinically confirmed of chronic migraine&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Primary headache disorder other than migraine&#xD;
&#xD;
          -  Secondary headache disorders other than medication-overuse headache or unclassified&#xD;
             headache, or&#xD;
&#xD;
          -  Aged under 18 years or older than 65 years&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Esmael M Ahmed, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Assistant Prof of Neurology</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Mansoura University Hospital</name>
      <address>
        <city>Mansoura</city>
        <state>Dakahlia</state>
        <zip>35516</zip>
        <country>Egypt</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <reference>
    <citation>Kavuk I, Yavuz A, Cetindere U, Agelink MW, Diener HC. Epidemiology of chronic daily headache. Eur J Med Res. 2003 Jun 30;8(6):236-40.</citation>
    <PMID>12911872</PMID>
  </reference>
  <reference>
    <citation>Bigal ME, Lipton RB, Tepper SJ, Rapoport AM, Sheftell FD. Primary chronic daily headache and its subtypes in adolescents and adults. Neurology. 2004 Sep 14;63(5):843-7. doi: 10.1212/01.wnl.0000137039.08724.18.</citation>
    <PMID>15365134</PMID>
  </reference>
  <reference>
    <citation>Silberstein SD. Chronic daily headache. J Am Osteopath Assoc. 2005 Apr;105(4 Suppl 2):23S-29S.</citation>
    <PMID>15928350</PMID>
  </reference>
  <reference>
    <citation>Bigal ME, Lipton RB. Modifiable risk factors for migraine progression. Headache. 2006 Oct;46(9):1334-43. doi: 10.1111/j.1526-4610.2006.00577.x.</citation>
    <PMID>17040331</PMID>
  </reference>
  <reference>
    <citation>Bigal ME, Lipton RB. Obesity is a risk factor for transformed migraine but not chronic tension-type headache. Neurology. 2006 Jul 25;67(2):252-7. doi: 10.1212/01.wnl.0000225052.35019.f9.</citation>
    <PMID>16864817</PMID>
  </reference>
  <verification_date>May 2020</verification_date>
  <study_first_submitted>May 30, 2020</study_first_submitted>
  <study_first_submitted_qc>May 30, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 2, 2020</study_first_posted>
  <last_update_submitted>May 30, 2020</last_update_submitted>
  <last_update_submitted_qc>May 30, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 2, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Mansoura University Hospital</investigator_affiliation>
    <investigator_full_name>Ahmed Esmael</investigator_full_name>
    <investigator_title>Assistant Prof of Neurology</investigator_title>
  </responsible_party>
  <keyword>MIGRAINE</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Migraine 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/NCT04413110
org study id: Mansoura University migraine
nct id: NCT04413110
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Transformed migraine is the most common and challenging subtype of chronic daily headache
      disorders35. Patients with transformed migraine often report an evolutionary process that
      occurs over months or years in which headaches increase in frequency, change characteristics
      and ultimately result in patterns of daily or near-daily headaches resembling a mixture of
      tension-type headache and migraine.
The present study aimed to investigate the presence and frequency of cognitive affection in
      patients with transformed migraines, as well as to analyze the association of cognitive
      affection with clinical features and headache impact, anxiety, depression, and quality of
      sleep.
observational model: Case-Control
time perspective: Retrospective
measure: Polysomnography
time frame: 24-72 hours
description: PSG was carried out for 41 patients with subjective cognitive impairment and 41 age and sex-matched controls. PSG with standard EEG montage that includes bilateral EOG and four EEG leads were used. A single attended overnight PSG study was performed at the Clinical Neurophysiology Unit of Mansoura University Hospitals. Patients were studied in a quiet, darkened room with no medications were used to induce sleep. All participants underwent one night of laboratory-based PSG.
arm group label: Non-subjective cognitive impaired
description: Cases of migraine and non-subjective cognitive impaired
arm group label: Subjective cognitive impaired
description: Cases of migraine and subjective cognitive impaired
arm group label: Control group
description: Age and sex matched healthy controls
intervention type: Device
intervention name: Polysomnography
description: PSG was carried out for 41 patients with subjective cognitive impairment and 41 age and sex-matched controls. PSG with standard EEG montage that includes bilateral EOG and four EEG leads were used. A single attended overnight PSG study was performed at the Clinical Neurophysiology Unit of Mansoura University Hospitals. Patients were studied in a quiet, darkened room with no medications were used to induce sleep. All participants underwent one night of laboratory-based PSG.
arm group label: Control group
arm group label: Subjective cognitive impaired
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Esmael M Ahmed, MD
role: Principal Investigator
affiliation: Assistant Prof of Neurology
facility: 
country: Egypt
citation: Kavuk I, Yavuz A, Cetindere U, Agelink MW, Diener HC. Epidemiology of chronic daily headache. Eur J Med Res. 2003 Jun 30;8(6):236-40.
PMID: 12911872
citation: Bigal ME, Lipton RB, Tepper SJ, Rapoport AM, Sheftell FD. Primary chronic daily headache and its subtypes in adolescents and adults. Neurology. 2004 Sep 14;63(5):843-7. doi: 10.1212/01.wnl.0000137039.08724.18.
PMID: 15365134
citation: Silberstein SD. Chronic daily headache. J Am Osteopath Assoc. 2005 Apr;105(4 Suppl 2):23S-29S.
PMID: 15928350
citation: Bigal ME, Lipton RB. Modifiable risk factors for migraine progression. Headache. 2006 Oct;46(9):1334-43. doi: 10.1111/j.1526-4610.2006.00577.x.
PMID: 17040331
citation: Bigal ME, Lipton RB. Obesity is a risk factor for transformed migraine but not chronic tension-type headache. Neurology. 2006 Jul 25;67(2):252-7. doi: 10.1212/01.wnl.0000225052.35019.f9.
PMID: 16864817
responsible party type: Principal Investigator
investigator affiliation: Mansoura University Hospital
investigator full name: Ahmed Esmael
investigator title: Assistant Prof of Neurology
mesh term: Migraine Disorders
sharing ipd: No