<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/NCT02233166</url>
  </required_header>
  <id_info>
    <org_study_id>2012/1117</org_study_id>
    <nct_id>NCT02233166</nct_id>
  </id_info>
  <brief_title>OSA in Children Referred for Adenotonsillectomy</brief_title>
  <official_title>Obstructive Sleep Apnea in Children Referred for Adenotonsillectomy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Lovisenberg Diakonale Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Lovisenberg Diakonale Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      In children with OSA (Obstructive sleep apnea) adenotonsillectomy is regarded as the first&#xD;
      choice of treatment. Studies in recent years have shown that the procedure does not always&#xD;
      have the expected effect. Children with OSA are at greater risk for complications from the&#xD;
      procedure.&#xD;
&#xD;
      There is disagreement regarding the need for sleep studies in children prior to surgery in&#xD;
      order to verify an OSA diagnosis. Today less than 10% of these children have polysomnography&#xD;
      (PSG).&#xD;
&#xD;
      The main purpose of this study is to describe the prevalence of OSA among children referred&#xD;
      for adenotonsillectomy.&#xD;
&#xD;
      The investigators will also examine these children prior to and six months after surgery to&#xD;
      assess their sleep pattern and quality of life.&#xD;
&#xD;
      The project outcome aims to improve the precision and quality of diagnosis and the short and&#xD;
      long term effects of treatment of children with OSA.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>August 2014</start_date>
  <completion_date type="Anticipated">December 2017</completion_date>
  <primary_completion_date type="Anticipated">December 2017</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 OSA</measure>
    <time_frame>Up to 2 years</time_frame>
    <description>Apne hypopne index (AHI)/ respiratory disturbance index (RDI)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Post operative PSG results</measure>
    <time_frame>Up to 2 years</time_frame>
    <description>Apne hypopne index (AHI)/ respiratory disturbance index (RDI)</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Quality of life</measure>
    <time_frame>Up to 2 years</time_frame>
    <description>Questionnaire</description>
  </other_outcome>
  <other_outcome>
    <measure>Risk factors of OSA</measure>
    <time_frame>Up to 2 years</time_frame>
    <description>Questionnaire</description>
  </other_outcome>
  <other_outcome>
    <measure>Post operative complications</measure>
    <time_frame>Up to 2 years</time_frame>
    <description>Questionnaire; pulse oximetry</description>
  </other_outcome>
  <enrollment type="Anticipated">115</enrollment>
  <condition>Obstructive Sleep Apnea</condition>
  <biospec_retention>Samples Without DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Blood sample&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Children aged between 2 and 5 years who are referred for adenoidectomy and/or&#xD;
        tonsillectomy.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  age 2-5 year&#xD;
&#xD;
          -  referred for adenoidectomy and/or tonsillectomy&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  craniofacial anomalies&#xD;
&#xD;
          -  neurological diseases&#xD;
&#xD;
          -  neuropsychiatric diseases&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>2 Years</minimum_age>
    <maximum_age>5 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Lovisenberg Diakonale Hospital</name>
      <address>
        <city>Oslo</city>
        <zip>0456</zip>
        <country>Norway</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Britt Øverland, PhD</last_name>
      <phone>+4723226326</phone>
      <email>brov@lds.no</email>
    </contact>
    <contact_backup>
      <last_name>Hanne Berdal, MD</last_name>
      <phone>+4723226381</phone>
      <email>habs@lds.no</email>
    </contact_backup>
    <investigator>
      <last_name>Britt Øverland, PhD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Norway</country>
  </location_countries>
  <verification_date>September 2015</verification_date>
  <study_first_submitted>August 13, 2014</study_first_submitted>
  <study_first_submitted_qc>September 5, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 8, 2014</study_first_posted>
  <last_update_submitted>August 22, 2017</last_update_submitted>
  <last_update_submitted_qc>August 22, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">August 23, 2017</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>Sleep Apnea Syndromes</mesh_term>
    <mesh_term>Sleep Apnea, Obstructive</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/NCT02233166
org study id: 2012/1117
nct id: NCT02233166
lead sponsor: 
has dmc: No
In children with OSA (Obstructive sleep apnea) adenotonsillectomy is regarded as the first
      choice of treatment. Studies in recent years have shown that the procedure does not always
      have the expected effect. Children with OSA are at greater risk for complications from the
      procedure.

      There is disagreement regarding the need for sleep studies in children prior to surgery in
      order to verify an OSA diagnosis. Today less than 10% of these children have polysomnography
      (PSG).

      The main purpose of this study is to describe the prevalence of OSA among children referred
      for adenotonsillectomy.

      The investigators will also examine these children prior to and six months after surgery to
      assess their sleep pattern and quality of life.

      The project outcome aims to improve the precision and quality of diagnosis and the short and
      long term effects of treatment of children with OSA.
observational model: Cohort
time perspective: Prospective
measure: Prevalence of OSA
time frame: Up to 2 years
description: Apne hypopne index (AHI)/ respiratory disturbance index (RDI)
measure: Post operative PSG results
time frame: Up to 2 years
description: Apne hypopne index (AHI)/ respiratory disturbance index (RDI)
measure: Quality of life
time frame: Up to 2 years
description: Questionnaire
measure: Risk factors of OSA
time frame: Up to 2 years
description: Questionnaire
measure: Post operative complications
time frame: Up to 2 years
description: Questionnaire; pulse oximetry
Blood sample
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 2 Years
maximum age: 5 Years
healthy volunteers: No
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
country: Norway
responsible party type: Sponsor
mesh term: Sleep Apnea Syndromes
mesh term: Sleep Apnea, Obstructive