xml: <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/NCT06012513</url>
    </required_header>
    <id_info>
      <org_study_id>sleep disorders in MS</org_study_id>
      <nct_id>NCT06012513</nct_id>
    </id_info>
    <brief_title>Sleep Disorders and Quality of Life in Patients With Multiple Sclerosis</brief_title>
    <official_title>Sleep Disorders and Quality of Life in Patients With Multiple Sclerosis</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Assiut University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Assiut University</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>
        1. To determine sleep disturbance in different types of multiple sclerosis.&#xD;
  &#xD;
          2. To asses the effect of sleep disturbance on quality of life in patients with multiple&#xD;
             sclerosis.&#xD;
  &#xD;
          3. Correlation between sleep disturbance in different types of multiple sclerosis.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Multiple sclerosis(MS) is a neurodegenerative disease of the central nervous system that&#xD;
        commonly affects young adults. The disease is characterized by neurological symptoms that may&#xD;
        lead to long-term physical disability. Patients with MS have many other problems associated&#xD;
        with their disease, as obstructive sleep apnea (OSA) that characterized by obstructions of&#xD;
        the respiratory tract throughout the night leadind to wake up the patients many times to&#xD;
        achieve the right muscle tone and receive adequate oxygenation. Most patients with MS&#xD;
        complain from poor sleep.It may be due to pain, fatigue, depression and immunotherapy that&#xD;
        have been considered as potential factors, which could have role in sleep disturbances among&#xD;
        MS patients.Restless leg syndrome (RLS) may trigger sleep disorders, especially insomnia, in&#xD;
        patients with MS. Patients with sleep disorders may complain excessive daytime sleepiness,&#xD;
        impaired concentration, altered mood, and fatigue. they are at risk to develop other&#xD;
        problems,as vascular diseases, obesity, and diabetes, which further threaten long-term&#xD;
        health.So patients with MS have lower quality of life(QoL) than healthy ones. Multiple&#xD;
        Sclerosis Quality of Life-54 (MSQoL-54) questionnaire is the most common and standardized&#xD;
        disease-specific questionnaire that based on the generic SF-36 QoL instrument.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 2023</start_date>
    <completion_date type="Anticipated">December 2025</completion_date>
    <primary_completion_date type="Anticipated">September 2025</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>Identification of different types of sleep disorders in patients with multiple sclerosis</measure>
      <time_frame>Baseline</time_frame>
      <description>Identification of different types of sleep disorders in patients with multiple sclerosis using different scales</description>
    </primary_outcome>
    <enrollment type="Anticipated">60</enrollment>
    <condition>Sleep Disorder</condition>
    <eligibility>
      <study_pop>
        <textblock>
          Patients diagnosed with Multiple Sclerosis according to McDonald Criteria 2017 attending&#xD;
          the neurology outpatient clinic, Department of Neurology and Psychiatry,Assiut University&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. All patients fulfill the criteria of case definition of multiple sclerosis.&#xD;
  &#xD;
            2. Gender: both sexes are included.&#xD;
  &#xD;
            3. Willingness to participate in the study and to be subjected to the disease-related&#xD;
               examinations and assessments.&#xD;
  &#xD;
            4. Willing and able to provide informed consent.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. Patients unable to give informed consent.&#xD;
  &#xD;
            2. Patients with history of psychiatric disorders or collagen disease such as Behcet's&#xD;
               disease or other neurological or medical disease&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>20 Years</minimum_age>
      <maximum_age>75 Years</maximum_age>
    </eligibility>
    <overall_contact>
      <last_name>Mohammed Safwat Mahmoud Ahmed, Resident doctor</last_name>
      <phone>01270577899</phone>
      <email>mhmdsfwt746@gmail.com</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Tareq Ali Sayed Rageh, professor</last_name>
      <phone>01010077712</phone>
      <email>tarek-rageh@hotmail.com</email>
    </overall_contact_backup>
    <reference>
      <citation>Tachibana N, Howard RS, Hirsch NP, Miller DH, Moseley IF, Fish D. Sleep problems in multiple sclerosis. Eur Neurol. 1994;34(6):320-3. doi: 10.1159/000117070.</citation>
      <PMID>7851452</PMID>
    </reference>
    <reference>
      <citation>Merlino G, Fratticci L, Lenchig C, Valente M, Cargnelutti D, Picello M, Serafini A, Dolso P, Gigli GL. Prevalence of 'poor sleep' among patients with multiple sclerosis: an independent predictor of mental and physical status. Sleep Med. 2009 Jan;10(1):26-34. doi: 10.1016/j.sleep.2007.11.004. Epub 2008 Jan 22.</citation>
      <PMID>18207453</PMID>
    </reference>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>July 27, 2023</study_first_submitted>
    <study_first_submitted_qc>August 24, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 25, 2023</study_first_posted>
    <last_update_submitted>August 24, 2023</last_update_submitted>
    <last_update_submitted_qc>August 24, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 25, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Assiut University</investigator_affiliation>
      <investigator_full_name>Mohammed Safwat Mahmoud Ahmed</investigator_full_name>
      <investigator_title>Doctor</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Multiple Sclerosis</mesh_term>
      <mesh_term>Sleep Wake Disorders</mesh_term>
      <mesh_term>Parasomnias</mesh_term>
    </condition_browse>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06012513
  org study id: sleep disorders in MS
  nct id: NCT06012513
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  1. To determine sleep disturbance in different types of multiple sclerosis.
  
          2. To asses the effect of sleep disturbance on quality of life in patients with multiple
             sclerosis.
  
          3. Correlation between sleep disturbance in different types of multiple sclerosis.
  Multiple sclerosis(MS) is a neurodegenerative disease of the central nervous system that
        commonly affects young adults. The disease is characterized by neurological symptoms that may
        lead to long-term physical disability. Patients with MS have many other problems associated
        with their disease, as obstructive sleep apnea (OSA) that characterized by obstructions of
        the respiratory tract throughout the night leadind to wake up the patients many times to
        achieve the right muscle tone and receive adequate oxygenation. Most patients with MS
        complain from poor sleep.It may be due to pain, fatigue, depression and immunotherapy that
        have been considered as potential factors, which could have role in sleep disturbances among
        MS patients.Restless leg syndrome (RLS) may trigger sleep disorders, especially insomnia, in
        patients with MS. Patients with sleep disorders may complain excessive daytime sleepiness,
        impaired concentration, altered mood, and fatigue. they are at risk to develop other
        problems,as vascular diseases, obesity, and diabetes, which further threaten long-term
        health.So patients with MS have lower quality of life(QoL) than healthy ones. Multiple
        Sclerosis Quality of Life-54 (MSQoL-54) questionnaire is the most common and standardized
        disease-specific questionnaire that based on the generic SF-36 QoL instrument.
  observational model: Case-Control
  time perspective: Prospective
  measure: Identification of different types of sleep disorders in patients with multiple sclerosis
  time frame: Baseline
  description: Identification of different types of sleep disorders in patients with multiple sclerosis using different scales
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 20 Years
  maximum age: 75 Years
  last name: Mohammed Safwat Mahmoud Ahmed, Resident doctor
  phone: 01270577899
  email: mhmdsfwt746@gmail.com
  last name: Tareq Ali Sayed Rageh, professor
  phone: 01010077712
  email: tarek-rageh@hotmail.com
  citation: Tachibana N, Howard RS, Hirsch NP, Miller DH, Moseley IF, Fish D. Sleep problems in multiple sclerosis. Eur Neurol. 1994;34(6):320-3. doi: 10.1159/000117070.
  PMID: 7851452
  citation: Merlino G, Fratticci L, Lenchig C, Valente M, Cargnelutti D, Picello M, Serafini A, Dolso P, Gigli GL. Prevalence of 'poor sleep' among patients with multiple sclerosis: an independent predictor of mental and physical status. Sleep Med. 2009 Jan;10(1):26-34. doi: 10.1016/j.sleep.2007.11.004. Epub 2008 Jan 22.
  PMID: 18207453
  responsible party type: Principal Investigator
  investigator affiliation: Assiut University
  investigator full name: Mohammed Safwat Mahmoud Ahmed
  investigator title: Doctor
  mesh term: Multiple Sclerosis
  mesh term: Sleep Wake Disorders
  mesh term: Parasomnias