<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/NCT01667588</url>
  </required_header>
  <id_info>
    <org_study_id>1000031590</org_study_id>
    <nct_id>NCT01667588</nct_id>
  </id_info>
  <brief_title>Sleep Disorders in Pediatric Dialysis</brief_title>
  <official_title>Sleep Disorders in Pediatric Dialysis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>The Hospital for Sick Children</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>The Hospital for Sick Children</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Sleep disorders (SD) are common in adults with Chronic Kidney Disease (CKD) on dialysis with&#xD;
      a reported prevalence of 60-80%. To date three studies have reported on SDs in children with&#xD;
      CKD but these have all been based on questionnaire data alone. The findings were not&#xD;
      confirmed with polysomnograms (PSG), the gold standard to diagnose SD, or actigraphy, a&#xD;
      validated tool to assess the sleep/ wake cycle over a prolonged period in the home. This is&#xD;
      highly relevant given the poor sensitivity and specificity of even validated questionnaires&#xD;
      alone. The effect of untreated pediatric SD is pervasive. This study will provide the first&#xD;
      objective assessment of SDs using PSGs in children with severe CKD, both on and off dialysis.&#xD;
      Therefore, we will recognize and when possible treat SD in this severe CKD cohort potentially&#xD;
      contributing to their immediate management (eg improved control of hypertension, improved&#xD;
      school performance), while improving their Quality of Life (QOL) and helping ensure they&#xD;
      achieve their full potential.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>August 2012</start_date>
  <completion_date type="Actual">March 2014</completion_date>
  <primary_completion_date type="Actual">March 2014</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>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Prevalence of Sleep Disorders</measure>
    <time_frame>Baseline</time_frame>
    <description>Report the prevalence of sleep disorders in a cohort of severe Chronic Kidney Disorder children both on and off dialysis based on PSG, actigraphy, and questionnaire.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Quality of Life</measure>
    <time_frame>Baseline</time_frame>
    <description>The Pediatric Quality of Life Inventory (Peds QL) generic core (version 4.0) scale is a 23-item multidimensional instrument for measuring pediatric HRQL.</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">19</enrollment>
  <condition>Chronic Kidney Disease (CKD)</condition>
  <arm_group>
    <arm_group_label>Pre-Dialysis</arm_group_label>
  </arm_group>
  <arm_group>
    <arm_group_label>Dialysis</arm_group_label>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        The two study cohorts will be age and sex matched and constructed as follows:&#xD;
&#xD;
          1. Pre-dialysis: Stage 4 CKD with an estimated GFR of 15-30 ml/min/1.73m2 based on IDMS&#xD;
             Schwartz GFR&#xD;
&#xD;
          2. Dialysis: CKD receiving outpatient hemodialysis (HD) or peritoneal dialysis (PD) for a&#xD;
             minimum of 1 month. The PSG will be completed after the longest inter-dialytic&#xD;
             interval for HD patients. Patients on PD will undergo PSG while on their usual cycler&#xD;
             nocturnal dialysis regimen.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  0 to 18 years&#xD;
&#xD;
          -  Caregivers must be able to read English&#xD;
&#xD;
          -  Patients with either Stage 4 Chronic Kidney Disease (CKD) with an estimated GFR of&#xD;
             15-30 ml/min/1.73m2 based on IDMS Schwartz GFR OR patients with CKD receiving&#xD;
             outpatient hemodialysis (HD) or peritoneal dialysis (PD) for a minimum of 1 month&#xD;
&#xD;
          -  Informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Caregivers cannot read English&#xD;
&#xD;
          -  Informed consent not given&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>1 Day</minimum_age>
    <maximum_age>18 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Reshma Amin, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>The Hospital for Sick Children</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>The Hospital for Sick Children</name>
      <address>
        <city>Toronto</city>
        <state>Ontario</state>
        <zip>M5G 1X8</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>May 2015</verification_date>
  <study_first_submitted>August 15, 2012</study_first_submitted>
  <study_first_submitted_qc>August 15, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 17, 2012</study_first_posted>
  <last_update_submitted>May 20, 2015</last_update_submitted>
  <last_update_submitted_qc>May 20, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">May 22, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>The Hospital for Sick Children</investigator_affiliation>
    <investigator_full_name>Reshma Amin</investigator_full_name>
    <investigator_title>Staff Respirologist</investigator_title>
  </responsible_party>
  <keyword>Chronic Kidney Disease (CKD)</keyword>
  <keyword>Pediatrics</keyword>
  <keyword>Sleep Disorders</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>Kidney Diseases</mesh_term>
    <mesh_term>Renal Insufficiency, Chronic</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/NCT01667588
org study id: 1000031590
nct id: NCT01667588
lead sponsor: 
has dmc: No
Sleep disorders (SD) are common in adults with Chronic Kidney Disease (CKD) on dialysis with
      a reported prevalence of 60-80%. To date three studies have reported on SDs in children with
      CKD but these have all been based on questionnaire data alone. The findings were not
      confirmed with polysomnograms (PSG), the gold standard to diagnose SD, or actigraphy, a
      validated tool to assess the sleep/ wake cycle over a prolonged period in the home. This is
      highly relevant given the poor sensitivity and specificity of even validated questionnaires
      alone. The effect of untreated pediatric SD is pervasive. This study will provide the first
      objective assessment of SDs using PSGs in children with severe CKD, both on and off dialysis.
      Therefore, we will recognize and when possible treat SD in this severe CKD cohort potentially
      contributing to their immediate management (eg improved control of hypertension, improved
      school performance), while improving their Quality of Life (QOL) and helping ensure they
      achieve their full potential.
observational model: Cohort
time perspective: Prospective
measure: Prevalence of Sleep Disorders
time frame: Baseline
description: Report the prevalence of sleep disorders in a cohort of severe Chronic Kidney Disorder children both on and off dialysis based on PSG, actigraphy, and questionnaire.
measure: Quality of Life
time frame: Baseline
description: The Pediatric Quality of Life Inventory (Peds QL) generic core (version 4.0) scale is a 23-item multidimensional instrument for measuring pediatric HRQL.
arm group label: Pre-Dialysis
arm group label: Dialysis
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 1 Day
maximum age: 18 Years
healthy volunteers: No
last name: Reshma Amin, MD
role: Principal Investigator
affiliation: The Hospital for Sick Children
facility: 
country: Canada
responsible party type: Principal Investigator
investigator affiliation: The Hospital for Sick Children
investigator full name: Reshma Amin
investigator title: Staff Respirologist
mesh term: Sleep Wake Disorders
mesh term: Parasomnias
mesh term: Kidney Diseases
mesh term: Renal Insufficiency, Chronic