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/NCT05971498</url>
    </required_header>
    <id_info>
      <org_study_id>AssiutU SLE</org_study_id>
      <nct_id>NCT05971498</nct_id>
    </id_info>
    <brief_title>Assessment of Anxiety, Depression, Sleep Quality and Quality of Life in Systemic Lupus Erythematosus Patients</brief_title>
    <official_title>Assessment of Anxiety, Depression, Sleep Quality and Quality of Life in Systemic Lupus Erythematosus Patients</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Assiut University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Assiut University</source>
    <brief_summary>
      <textblock>
        The goal of this case control observational study is to asses anxiety, sleep, depression and&#xD;
        quality of life in Systemic Lupus Erythematosus (SLE) patients.&#xD;
  &#xD;
        The main aims are:&#xD;
  &#xD;
          -  asses anxiety, sleep, depression and quality of life in SLE patients&#xD;
  &#xD;
          -  their relation to disease activity&#xD;
  &#xD;
        we will compare SLE patients to healthy subjects.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        All patients will be subjected to clinical evaluation (full history and examination,&#xD;
        laboratory evaluation (include erythrocyte sedimentation rate (ESR) measured by standard&#xD;
        westergren method (mm/h), serum C-reactive protein (CRP), complete blood count (CBC), serum&#xD;
        urea and creatinine, aspartate transaminase (AST), alanine transaminase (ALT), complete urine&#xD;
        analysis for: urinary casts (hyaline, granular), hematuria (RBCs/ high power field), pyuria&#xD;
        (WBCs/ high power field), 24-hour urinary protein and creatinine clearance. Immunological&#xD;
        work up will include antinuclear antibodies (ANA) by ELISA, anti-double stranded DNA (ds-DNA)&#xD;
        by ELISA and complement components C3 and C4 by nephelometry. Disease activity will be&#xD;
        assessed via SLE disease activity index (SLEDAI): SLEDAI is based on the presence of 24&#xD;
        descriptors in nine organ systems over the preceding 30 days. Descriptors of SLEDAI are&#xD;
        documented as present or absent. Each of the descriptors has a weighted score and the total&#xD;
        score of SLEDAI is the sum of all 24 descriptor scores. The total score falls between 0 and&#xD;
        105, with higher scores representing higher disease activity.&#xD;
  &#xD;
        Psychological assessment will be performed according to the following scales&#xD;
  &#xD;
          -  Hamilton Anxiety Rating Scale (HAM-A): It consists of 14 items and measures both psychic&#xD;
             and somatic anxiety (physical complaints related to anxiety). Each item is scored on a&#xD;
             scale of 0 (not present) to 4 (severe), with a total score range of 0-56, where a score&#xD;
             ≤ 17 indicates mild anxiety, 18-24 mild to moderate anxiety, , 25-30 moderate to severe&#xD;
             anxiety and scores &gt;30 indicate severe anxiety.&#xD;
  &#xD;
          -  Hamilton Depression Rating Scale: the original scale has 21 items, but scoring is based&#xD;
             only on the first 17. Scores less than or equal to 7 indicates normal response, 8-13&#xD;
             mild depression, 14-18 Moderate, 19-22 severe, and &gt; 22 very severe depression.&#xD;
  &#xD;
        Sleep quality assessment was done via&#xD;
  &#xD;
          -  Insomnia severity index (ISI) : contains seven domains assessing sleep-onset&#xD;
             difficulties, sleep maintenance, sleep satisfaction, effect on daily functioning,&#xD;
             impairment attributed to sleep problems, and distress associated with insomnia. Each&#xD;
             item is rated on a 0-4 scale, and the total score ranges from 0 to 28. A higher score&#xD;
             suggests more severe insomnia.&#xD;
  &#xD;
          -  Epworth sleepiness scale : subjects describe how often they fall asleep in certain&#xD;
             situations on a scale of 0-3, with total scores ranging from 0 to 24. An ESS score ≥ 10&#xD;
             is indicative of subjective excessive daytime sleepiness and score &gt; 16 indicates high&#xD;
             level of daytime sleepiness.&#xD;
  &#xD;
        Pittsburgh Sleep Quality Index the first 4 items are open questions, whereas items 5 to 19&#xD;
        are rated on a 4-point Likert scale. Individual items scores yield 7 components (sleep&#xD;
        duration, sleep disturbance, sleep latency, daytime dysfunction due to sleepiness, sleep&#xD;
        efficiency, overall sleep quality, and sleep medication use). The scores for each component&#xD;
        are summed to get a total score (range 0-21). A score &gt; 5 suggests poor sleep quality.&#xD;
  &#xD;
        Assessment of Health status and quality of life via short form health survey&#xD;
        (SF36):Thirty-five of the 36 items are grouped into eight scales: physical functioning, role&#xD;
        limitations due to physical problems, bodily pain, general health, vitality, social&#xD;
        functioning, role limitations due to emotional problems, and mental health. One item assesses&#xD;
        perception of changes in health over the last year but is not used calculate scale scores.&#xD;
        Higher scores indicate high quality of life.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">August 14, 2023</start_date>
    <completion_date type="Anticipated">March 1, 2024</completion_date>
    <primary_completion_date type="Anticipated">February 1, 2024</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>Cross-Sectional</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>Evaluation of insomnia in SLE patients by Insomnia severity index</measure>
      <time_frame>3 MONTHS</time_frame>
      <description>insomnia severity index contains seven domains assessing sleep-onset difficulties, sleep maintenance, sleep satisfaction, effect on daily functioning, impairment attributed to sleep problems, and distress associated with insomnia. Each item is rated on a 0-4 scale, and th e total score ranges from 0 to 28. A higher score suggests more severe insomnia</description>
    </primary_outcome>
    <primary_outcome>
      <measure>evaluation of excessive daytime sleepiness in SLE patients by Epworth sleepiness scale</measure>
      <time_frame>3 months</time_frame>
      <description>Subjects describe how often they fall asleep in certain situations on a scale of 0-3, with total scores ranging from 0 to 24. An ESS score ≥ 10 is indicative of subjective excessive daytime sleepiness and score &gt; 16 indicates high level of daytime sleepiness</description>
    </primary_outcome>
    <primary_outcome>
      <measure>evaluation of anxiety in SLE patients by hamilton anxiety rating scale</measure>
      <time_frame>3 months</time_frame>
      <description>It consists of 14 items and measures both psychic and somatic anxiety (physical complaints related to anxiety). Each item is scored on a scale of 0 (not present) to 4 (severe), with a total score range of 0-56, where a score ≤ 17 indicates mild anxiety, 18-24 mild to moderate anxiety, , 25-30 moderate to severe anxiety and scores &gt;30 indicate severe anxiety</description>
    </primary_outcome>
    <primary_outcome>
      <measure>evaluation of depression in SLE patients by hamilton depression rating scale</measure>
      <time_frame>3 months</time_frame>
      <description>The original scale has 21 items, but scoring is based only on the first 17 with total score ranges from 0 to 52. Scores less than or equal to 7 indicates normal response, 8-13 mild depression, 14-18 Moderate, 19-22 severe, and &gt; 22 very severe depression.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>evaluation of QoL in SLE patients by short form health survey (sf36 )</measure>
      <time_frame>3 months</time_frame>
      <description>Thirty-five of the 36 items are grouped into eight scales: physical functioning, role limitations due to physical problems, bodily pain, general health, vitality, social functioning, role limitations due to emotional problems, and mental health. One item assesses perception of changes in health over the last year but is not used calculate scale scores. Mean score ranges from 0 to100. High scores indicate lower disability</description>
    </primary_outcome>
    <primary_outcome>
      <measure>evaluation of sleep quality and disturbances in SLE patients by Pittsburgh Sleep Quality Index</measure>
      <time_frame>3 months</time_frame>
      <description>The first 4 items are open questions, whereas items 5 to 19 are rated on a 4-point Likert scale. Individual items scores yield 7 components (sleep duration, sleep disturbance, sleep latency, daytime dysfunction due to sleepiness, sleep efficiency, overall sleep quality, and sleep medication use). The scores for each component are summed to get a total score (range 0-21). A score &gt; 5 suggests poor sleep quality</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Correlation of disease activity (SLEDAI) with Hamilton anxiety rating scale, Hamilton depression rating scale, Epworth sleepiness scale,Pittsburgh Sleep Quality Index and short form health survey sf 36</measure>
      <time_frame>3 months</time_frame>
      <description>The SLEDAI consists of 24 items (nine organ systems) that are scored based on presence at the time of visit or in the preceding 10 days. The scoring is additive across items, with a possible total score range of 0 to 105 (higher scores represent greater disease activity).</description>
    </secondary_outcome>
    <number_of_groups>2</number_of_groups>
    <enrollment type="Anticipated">62</enrollment>
    <condition>Systemic Lupus Erythematosus</condition>
    <arm_group>
      <arm_group_label>cases</arm_group_label>
    </arm_group>
    <arm_group>
      <arm_group_label>control</arm_group_label>
    </arm_group>
    <eligibility>
      <study_pop>
        <textblock>
          SLE patients and healthy control&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Patients diagnosed with SLE according to the 2012 systemic lupus international&#xD;
               collaborating clinics (SLICC) criteria .&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Evidence of end-organ failures such as heart failure, liver cell or renal failure,&#xD;
  &#xD;
            -  History of psychological disorders .&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Maha Abdelrahman, MD,PhD</last_name>
      <phone>+201011212050</phone>
      <email>mahasayed@aun.edu.eg</email>
    </overall_contact>
    <location>
      <facility>
        <name>Faculty of medicine, Assiut university hospital</name>
        <address>
          <city>Assiut</city>
          <zip>71515</zip>
          <country>Egypt</country>
        </address>
      </facility>
      <status>Recruiting</status>
    </location>
    <location_countries>
      <country>Egypt</country>
    </location_countries>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>July 25, 2023</study_first_submitted>
    <study_first_submitted_qc>July 25, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 2, 2023</study_first_posted>
    <last_update_submitted>September 15, 2023</last_update_submitted>
    <last_update_submitted_qc>September 15, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 18, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Assiut University</investigator_affiliation>
      <investigator_full_name>Maha Sayed Ibrahim Abdelrahman</investigator_full_name>
      <investigator_title>Principal investigator</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Lupus Erythematosus, Systemic</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/NCT05971498
  org study id: AssiutU SLE
  nct id: NCT05971498
  lead sponsor: 
  The goal of this case control observational study is to asses anxiety, sleep, depression and
        quality of life in Systemic Lupus Erythematosus (SLE) patients.
  
        The main aims are:
  
          -  asses anxiety, sleep, depression and quality of life in SLE patients
  
          -  their relation to disease activity
  
        we will compare SLE patients to healthy subjects.
  All patients will be subjected to clinical evaluation (full history and examination,
        laboratory evaluation (include erythrocyte sedimentation rate (ESR) measured by standard
        westergren method (mm/h), serum C-reactive protein (CRP), complete blood count (CBC), serum
        urea and creatinine, aspartate transaminase (AST), alanine transaminase (ALT), complete urine
        analysis for: urinary casts (hyaline, granular), hematuria (RBCs/ high power field), pyuria
        (WBCs/ high power field), 24-hour urinary protein and creatinine clearance. Immunological
        work up will include antinuclear antibodies (ANA) by ELISA, anti-double stranded DNA (ds-DNA)
        by ELISA and complement components C3 and C4 by nephelometry. Disease activity will be
        assessed via SLE disease activity index (SLEDAI): SLEDAI is based on the presence of 24
        descriptors in nine organ systems over the preceding 30 days. Descriptors of SLEDAI are
        documented as present or absent. Each of the descriptors has a weighted score and the total
        score of SLEDAI is the sum of all 24 descriptor scores. The total score falls between 0 and
        105, with higher scores representing higher disease activity.
  
        Psychological assessment will be performed according to the following scales
  
          -  Hamilton Anxiety Rating Scale (HAM-A): It consists of 14 items and measures both psychic
             and somatic anxiety (physical complaints related to anxiety). Each item is scored on a
             scale of 0 (not present) to 4 (severe), with a total score range of 0-56, where a score
             ≤ 17 indicates mild anxiety, 18-24 mild to moderate anxiety, , 25-30 moderate to severe
             anxiety and scores >30 indicate severe anxiety.
  
          -  Hamilton Depression Rating Scale: the original scale has 21 items, but scoring is based
             only on the first 17. Scores less than or equal to 7 indicates normal response, 8-13
             mild depression, 14-18 Moderate, 19-22 severe, and > 22 very severe depression.
  
        Sleep quality assessment was done via
  
          -  Insomnia severity index (ISI) : contains seven domains assessing sleep-onset
             difficulties, sleep maintenance, sleep satisfaction, effect on daily functioning,
             impairment attributed to sleep problems, and distress associated with insomnia. Each
             item is rated on a 0-4 scale, and the total score ranges from 0 to 28. A higher score
             suggests more severe insomnia.
  
          -  Epworth sleepiness scale : subjects describe how often they fall asleep in certain
             situations on a scale of 0-3, with total scores ranging from 0 to 24. An ESS score ≥ 10
             is indicative of subjective excessive daytime sleepiness and score > 16 indicates high
             level of daytime sleepiness.
  
        Pittsburgh Sleep Quality Index the first 4 items are open questions, whereas items 5 to 19
        are rated on a 4-point Likert scale. Individual items scores yield 7 components (sleep
        duration, sleep disturbance, sleep latency, daytime dysfunction due to sleepiness, sleep
        efficiency, overall sleep quality, and sleep medication use). The scores for each component
        are summed to get a total score (range 0-21). A score > 5 suggests poor sleep quality.
  
        Assessment of Health status and quality of life via short form health survey
        (SF36):Thirty-five of the 36 items are grouped into eight scales: physical functioning, role
        limitations due to physical problems, bodily pain, general health, vitality, social
        functioning, role limitations due to emotional problems, and mental health. One item assesses
        perception of changes in health over the last year but is not used calculate scale scores.
        Higher scores indicate high quality of life.
  observational model: Case-Control
  time perspective: Cross-Sectional
  measure: Evaluation of insomnia in SLE patients by Insomnia severity index
  time frame: 3 MONTHS
  description: insomnia severity index contains seven domains assessing sleep-onset difficulties, sleep maintenance, sleep satisfaction, effect on daily functioning, impairment attributed to sleep problems, and distress associated with insomnia. Each item is rated on a 0-4 scale, and th e total score ranges from 0 to 28. A higher score suggests more severe insomnia
  measure: evaluation of excessive daytime sleepiness in SLE patients by Epworth sleepiness scale
  time frame: 3 months
  description: Subjects describe how often they fall asleep in certain situations on a scale of 0-3, with total scores ranging from 0 to 24. An ESS score ≥ 10 is indicative of subjective excessive daytime sleepiness and score > 16 indicates high level of daytime sleepiness
  measure: evaluation of anxiety in SLE patients by hamilton anxiety rating scale
  time frame: 3 months
  description: It consists of 14 items and measures both psychic and somatic anxiety (physical complaints related to anxiety). Each item is scored on a scale of 0 (not present) to 4 (severe), with a total score range of 0-56, where a score ≤ 17 indicates mild anxiety, 18-24 mild to moderate anxiety, , 25-30 moderate to severe anxiety and scores >30 indicate severe anxiety
  measure: evaluation of depression in SLE patients by hamilton depression rating scale
  time frame: 3 months
  description: The original scale has 21 items, but scoring is based only on the first 17 with total score ranges from 0 to 52. Scores less than or equal to 7 indicates normal response, 8-13 mild depression, 14-18 Moderate, 19-22 severe, and > 22 very severe depression.
  measure: evaluation of QoL in SLE patients by short form health survey (sf36 )
  time frame: 3 months
  description: Thirty-five of the 36 items are grouped into eight scales: physical functioning, role limitations due to physical problems, bodily pain, general health, vitality, social functioning, role limitations due to emotional problems, and mental health. One item assesses perception of changes in health over the last year but is not used calculate scale scores. Mean score ranges from 0 to100. High scores indicate lower disability
  measure: evaluation of sleep quality and disturbances in SLE patients by Pittsburgh Sleep Quality Index
  time frame: 3 months
  description: The first 4 items are open questions, whereas items 5 to 19 are rated on a 4-point Likert scale. Individual items scores yield 7 components (sleep duration, sleep disturbance, sleep latency, daytime dysfunction due to sleepiness, sleep efficiency, overall sleep quality, and sleep medication use). The scores for each component are summed to get a total score (range 0-21). A score > 5 suggests poor sleep quality
  measure: Correlation of disease activity (SLEDAI) with Hamilton anxiety rating scale, Hamilton depression rating scale, Epworth sleepiness scale,Pittsburgh Sleep Quality Index and short form health survey sf 36
  time frame: 3 months
  description: The SLEDAI consists of 24 items (nine organ systems) that are scored based on presence at the time of visit or in the preceding 10 days. The scoring is additive across items, with a possible total score range of 0 to 105 (higher scores represent greater disease activity).
  arm group label: cases
  arm group label: control
  study pop: 
  sampling method: Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: Accepts Healthy Volunteers
  last name: Maha Abdelrahman, MD,PhD
  phone: +201011212050
  email: mahasayed@aun.edu.eg
  facility: 
  status: Recruiting
  country: Egypt
  responsible party type: Principal Investigator
  investigator affiliation: Assiut University
  investigator full name: Maha Sayed Ibrahim Abdelrahman
  investigator title: Principal investigator
  mesh term: Lupus Erythematosus, Systemic