<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/NCT01676181</url>
  </required_header>
  <id_info>
    <org_study_id>2011/333-31/4</org_study_id>
    <nct_id>NCT01676181</nct_id>
  </id_info>
  <brief_title>ATT Compared With ATE in OSAS Children</brief_title>
  <acronym>RCT ATE/ATT</acronym>
  <official_title>Randomised Surgical Intervention Study Between Adenotonsillectomy and Adenotonsillotomy in Children With Obstructive Sleep Apnea Syndrome</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Karolinska University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Karolinska University Hospital</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Non-inferiority hypothesis; adenotonsillotomy is equally good as adenotonsillectomy in&#xD;
      treating obstructive sleep apnea syndrome (OSAS) in children after one, three and ten years.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Background: Children with obstructive sleep apnea syndrome (OSAS) have apneas and disturbed&#xD;
      sleep, which causes daytime symptoms such as neurobehavioral problems. OSAS is a significant&#xD;
      cause of morbidity among children with an incidence of 1-3%, and a peak prevalence at 2-5&#xD;
      years of age. If left untreated it can cause severe complications including failure to&#xD;
      thrive, cardiovascular complications, metabolic conditions and neurobehavioral disturbances&#xD;
      (eg hyperactivity, inattention).&#xD;
&#xD;
      Golden standard to diagnose OSA in children is full-night polysomnography (PSG) at a sleep&#xD;
      laboratory including EEG, EOG, EMG, video-audiometry and respiratory recordings. At the&#xD;
      Department of Otorhinolaryngology at Karolinska University Hospital, we have a sleep&#xD;
      laboratory performing in-lab full-night polysomnography.&#xD;
&#xD;
      The cause of OSAS in children is usually adenotonsillar hypertrophy, and the treatment of&#xD;
      choice is surgical removal of tonsils and adenoid. Traditionally total adenotonsillectomy&#xD;
      (ATE) has been performed, but in the last decade an alternative surgical method with partial&#xD;
      adenotonsillotomy (ATT) is developed, where only the medial portion of the tonsil is removed.&#xD;
      The newer method ATT is not fully evaluated in comparison with traditional ATE. There are&#xD;
      studies comparing evaluating post-operative pain and bleeding showing a slight advantage for&#xD;
      the TT-method. Very few studies are performed using objectively measured PSG-parameters to&#xD;
      evaluate the effect of surgery on the sleep fragmentation and the sleep apneas. There is a&#xD;
      need for such studies in the field of surgical treatment of pediatric OSA. This was also&#xD;
      stated in a Cochrane database review from 2009, in which the conclusion was that there is a&#xD;
      need for high quality randomised controlled trials to be carried out investigating the&#xD;
      efficacy of surgical treatment of OSA in children. This makes this study important and of&#xD;
      high clinical interest.&#xD;
&#xD;
      Aims: To increase the knowledge of pediatric OSA and its treatment and to optimize the&#xD;
      surgical treatment for children with OSA.&#xD;
&#xD;
      To through a blinded randomized controlled trial compare the efficacy of ATT and ATE in&#xD;
      treating OSA in children, including long-term follow-up after one, three and ten years.&#xD;
&#xD;
      To evaluate postoperative pain after ATE and ATT. To evaluate quality of life after ATE and&#xD;
      ATT.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>November 2011</start_date>
  <completion_date type="Actual">March 2017</completion_date>
  <primary_completion_date type="Actual">March 2017</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Triple (Participant, Care Provider, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Changes in polysomnographic parameter AHI (Apnea Hypopnea Index)</measure>
    <time_frame>One, three and ten years</time_frame>
    <description>AHI; the number of apneas and hypopneas per sleep hour, is measured through polysomnography before and after surgery.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Changes in quality of life questionnaires (OSA18 and SDQ)</measure>
    <time_frame>One, three and ten Years</time_frame>
    <description>Parents answering to quality of life-questionnaire OSA18 and SDQ (Strengths and Difficulties Questionnaire) before and after surgical intervention</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Per- and postoperative bleeding</measure>
    <time_frame>One year</time_frame>
    <description>The two groups (ATT and ATE) will be compared concerning per- and postoperative bleeding.</description>
  </other_outcome>
  <other_outcome>
    <measure>changes in polysomnographic parameters other than AHI</measure>
    <time_frame>one, three and ten years</time_frame>
    <description>Polysomnograhic parameters, for example; the oxygen desaturation index (ODI), lowest oxygen saturation, the respiratory disturbance index (RDI), AHI in REM, total sleep time, time in REM, deep sleep, supine position etc.</description>
  </other_outcome>
  <other_outcome>
    <measure>Differences in postoperative pain</measure>
    <time_frame>One year</time_frame>
    <description>The two groups will be compared with questionnaires and consumption of analgetics concerning the degree of postoperative pain.</description>
  </other_outcome>
  <other_outcome>
    <measure>Number of patients who need reoperations</measure>
    <time_frame>One, three and ten years</time_frame>
    <description>The patient may need reoperations, either because of postoperative bleeding or because the tonsils have regrowth</description>
  </other_outcome>
  <other_outcome>
    <measure>Abnormalities in DNA analysis of blood and tonsil tissue</measure>
    <time_frame>one year</time_frame>
    <description>Blood and tissue samples will be frozen for future analysis of DNA. We have not yet decided which method we will use. There are other studies suggesting abnormalities in certain enzymes in children with tonsillar hypertrophy</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">79</enrollment>
  <condition>Obstructive Sleep Apnea Syndrome in Children</condition>
  <arm_group>
    <arm_group_label>Adenotonsillectomy</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Total removal of tonsils and adenoids with cold steel</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Adenotonsillotomy</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Partial removal of tonsils with coblation and total removal of adenoids with cold steel</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Adenotonsillectomy</intervention_name>
    <description>Total removal of tonsils and adenoid tissue with cold-steel</description>
    <arm_group_label>Adenotonsillectomy</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Adenotonsillotomy</intervention_name>
    <description>Partial removal of tonsils with coblation and total removal of adenoids with cold steel</description>
    <arm_group_label>Adenotonsillotomy</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Children aged 2-6 years&#xD;
&#xD;
          -  Clinical symptoms of OSAS (apneas, snoring, disturbed sleep)&#xD;
&#xD;
          -  Tonsil size 3-4 with the Brodsky scale (obstructing at least 50% of the oro-pharyngeal&#xD;
             space)&#xD;
&#xD;
          -  Apnea-Hypopnea Index (AHI) 5-30 (moderate- severe OSA)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Clinical signs of craniofacial anomalies or neuromuscular disorders&#xD;
&#xD;
          -  Obesity&#xD;
&#xD;
          -  Earlier having had surgery of tonsils or adenoid&#xD;
&#xD;
          -  Bleeding disorder&#xD;
&#xD;
          -  Cardiopulmonary disorder&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>2 Years</minimum_age>
    <maximum_age>6 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Danielle Friberg, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Karolinska University Hospital, ORL dep</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Karolinska University Hospital, ORL dep</name>
      <address>
        <city>Stockholm</city>
        <zip>141 86</zip>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Sweden</country>
  </location_countries>
  <verification_date>March 2023</verification_date>
  <study_first_submitted>August 21, 2012</study_first_submitted>
  <study_first_submitted_qc>August 29, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 30, 2012</study_first_posted>
  <last_update_submitted>March 9, 2023</last_update_submitted>
  <last_update_submitted_qc>March 9, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">March 10, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Karolinska University Hospital</investigator_affiliation>
    <investigator_full_name>Danielle Friberg</investigator_full_name>
    <investigator_title>Associate Professor, senior surgeon</investigator_title>
  </responsible_party>
  <keyword>Obstructive sleep apnea syndrome</keyword>
  <keyword>Children</keyword>
  <keyword>Polysomnography</keyword>
  <keyword>Surgery</keyword>
  <keyword>Coblation</keyword>
  <keyword>Tonsils</keyword>
  <keyword>Tonsillectomy</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Apnea</mesh_term>
    <mesh_term>Sleep Apnea Syndromes</mesh_term>
    <mesh_term>Sleep Apnea, Obstructive</mesh_term>
    <mesh_term>Syndrome</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/NCT01676181
org study id: 2011/333-31/4
nct id: NCT01676181
lead sponsor: 
has dmc: Yes
Non-inferiority hypothesis; adenotonsillotomy is equally good as adenotonsillectomy in
      treating obstructive sleep apnea syndrome (OSAS) in children after one, three and ten years.
Background: Children with obstructive sleep apnea syndrome (OSAS) have apneas and disturbed
      sleep, which causes daytime symptoms such as neurobehavioral problems. OSAS is a significant
      cause of morbidity among children with an incidence of 1-3%, and a peak prevalence at 2-5
      years of age. If left untreated it can cause severe complications including failure to
      thrive, cardiovascular complications, metabolic conditions and neurobehavioral disturbances
      (eg hyperactivity, inattention).

      Golden standard to diagnose OSA in children is full-night polysomnography (PSG) at a sleep
      laboratory including EEG, EOG, EMG, video-audiometry and respiratory recordings. At the
      Department of Otorhinolaryngology at Karolinska University Hospital, we have a sleep
      laboratory performing in-lab full-night polysomnography.

      The cause of OSAS in children is usually adenotonsillar hypertrophy, and the treatment of
      choice is surgical removal of tonsils and adenoid. Traditionally total adenotonsillectomy
      (ATE) has been performed, but in the last decade an alternative surgical method with partial
      adenotonsillotomy (ATT) is developed, where only the medial portion of the tonsil is removed.
      The newer method ATT is not fully evaluated in comparison with traditional ATE. There are
      studies comparing evaluating post-operative pain and bleeding showing a slight advantage for
      the TT-method. Very few studies are performed using objectively measured PSG-parameters to
      evaluate the effect of surgery on the sleep fragmentation and the sleep apneas. There is a
      need for such studies in the field of surgical treatment of pediatric OSA. This was also
      stated in a Cochrane database review from 2009, in which the conclusion was that there is a
      need for high quality randomised controlled trials to be carried out investigating the
      efficacy of surgical treatment of OSA in children. This makes this study important and of
      high clinical interest.

      Aims: To increase the knowledge of pediatric OSA and its treatment and to optimize the
      surgical treatment for children with OSA.

      To through a blinded randomized controlled trial compare the efficacy of ATT and ATE in
      treating OSA in children, including long-term follow-up after one, three and ten years.

      To evaluate postoperative pain after ATE and ATT. To evaluate quality of life after ATE and
      ATT.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Triple (Participant, Care Provider, Outcomes Assessor)
measure: Changes in polysomnographic parameter AHI (Apnea Hypopnea Index)
time frame: One, three and ten years
description: AHI; the number of apneas and hypopneas per sleep hour, is measured through polysomnography before and after surgery.
measure: Changes in quality of life questionnaires (OSA18 and SDQ)
time frame: One, three and ten Years
description: Parents answering to quality of life-questionnaire OSA18 and SDQ (Strengths and Difficulties Questionnaire) before and after surgical intervention
measure: Per- and postoperative bleeding
time frame: One year
description: The two groups (ATT and ATE) will be compared concerning per- and postoperative bleeding.
measure: changes in polysomnographic parameters other than AHI
time frame: one, three and ten years
description: Polysomnograhic parameters, for example; the oxygen desaturation index (ODI), lowest oxygen saturation, the respiratory disturbance index (RDI), AHI in REM, total sleep time, time in REM, deep sleep, supine position etc.
measure: Differences in postoperative pain
time frame: One year
description: The two groups will be compared with questionnaires and consumption of analgetics concerning the degree of postoperative pain.
measure: Number of patients who need reoperations
time frame: One, three and ten years
description: The patient may need reoperations, either because of postoperative bleeding or because the tonsils have regrowth
measure: Abnormalities in DNA analysis of blood and tonsil tissue
time frame: one year
description: Blood and tissue samples will be frozen for future analysis of DNA. We have not yet decided which method we will use. There are other studies suggesting abnormalities in certain enzymes in children with tonsillar hypertrophy
arm group label: Adenotonsillectomy
arm group type: Active Comparator
description: Total removal of tonsils and adenoids with cold steel
arm group label: Adenotonsillotomy
arm group type: Active Comparator
description: Partial removal of tonsils with coblation and total removal of adenoids with cold steel
intervention type: Procedure
intervention name: Adenotonsillectomy
description: Total removal of tonsils and adenoid tissue with cold-steel
arm group label: Adenotonsillectomy
intervention type: Procedure
intervention name: Adenotonsillotomy
description: Partial removal of tonsils with coblation and total removal of adenoids with cold steel
arm group label: Adenotonsillotomy
criteria: 
gender: All
minimum age: 2 Years
maximum age: 6 Years
healthy volunteers: No
last name: Danielle Friberg, MD, PhD
role: Principal Investigator
affiliation: Karolinska University Hospital, ORL dep
facility: 
country: Sweden
responsible party type: Principal Investigator
investigator affiliation: Karolinska University Hospital
investigator full name: Danielle Friberg
investigator title: Associate Professor, senior surgeon
mesh term: Apnea
mesh term: Sleep Apnea Syndromes
mesh term: Sleep Apnea, Obstructive
mesh term: Syndrome