<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/NCT03821831</url>
  </required_header>
  <id_info>
    <org_study_id>GHeo</org_study_id>
    <nct_id>NCT03821831</nct_id>
  </id_info>
  <brief_title>Treating Children With Obstructive Sleep Apnea After Surgery Failure</brief_title>
  <official_title>Residual Pediatric Obstructive Sleep Apnea: Closing the Treatment Gap</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Alberta</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Natural Sciences and Engineering Research Council, Canada</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Alberta</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
    <is_unapproved_device>Yes</is_unapproved_device>
    <is_us_export>Yes</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      The aim of this study is to evaluate the potential improvement of sleep quality in children&#xD;
      who have residual obstructive sleep apnea, using either an orthodontic intervention or&#xD;
      continuous positive airway pressure (CPAP), versus no treatment.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Consenting patients and their parents will choose one of three options (within the context of&#xD;
      medical/craniofacial appropriateness): CPAP, orthodontic intervention, or to remain untreated&#xD;
      (control). It would be ideal if each patient was randomly assigned to one of three groups.&#xD;
      However, in our study, random allocation is not an option as the established clinical&#xD;
      pathways for treatment, financial resources, and physiological presentation of the patient&#xD;
      determines the appropriate intervention. In each group, the effectiveness of the intervention&#xD;
      will be analyzed through the evaluation of sleep parameters, medical history, questionnaire&#xD;
      responses, craniofacial characteristics, diet, and metabolomic markers, each at baseline and&#xD;
      at 12 months.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">December 3, 2021</start_date>
  <completion_date type="Anticipated">December 2026</completion_date>
  <primary_completion_date type="Anticipated">September 2026</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>Measure of change in OSA severity</measure>
    <time_frame>baseline and 12 months</time_frame>
    <description>Change from baseline Apnea-Hypopnea Index (OSA severity index) measurement by polysomnography at 12 months</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change from baseline total score Pediatric Sleep Questionnaire (PSQ) at 12 months</measure>
    <time_frame>baseline and 12 months</time_frame>
    <description>PSQ consists of total 22 questions with choices of answer; Yes or No. Yes answer will be coded as 1 and No answer coded as 0. Sum of 22 questions will be compared.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change from baseline body mass index (BMI) at 12 months</measure>
    <time_frame>baseline and 12 months</time_frame>
    <description>Height (m) and weight (kg) will be measured to calculate BMI (kg/m^2).</description>
  </secondary_outcome>
  <number_of_groups>3</number_of_groups>
  <enrollment type="Anticipated">100</enrollment>
  <condition>Pediatric Obstructive Sleep Apnea</condition>
  <condition>Pediatric Obesity</condition>
  <arm_group>
    <arm_group_label>Continuous Positive Airway Pressure</arm_group_label>
    <description>This group consists of consenting patients and their parents who choose Continuous Positive Airway Pressure (CPAP). The CPAP is a type of therapy that applies mild air pressure to a person's upper airway to keep their airway open so that they can breathe normally while they sleep.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Orthodontic Intervention</arm_group_label>
    <description>This group consists of consenting patients and their parents who choose orthodontic intervention will be seen by participating orthodontists who will determine types of orthodontic intervention; mandibular advancement devices or rapid maxillary expansion devices, or Class III mid face advancement with skeletal anchored headgear. In this group, the patients will also receive a biometric shirt to use once every two weeks, to monitor their sleep during the study.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <description>This group consists of consenting patients and their parents who choose to remain untreated. In this group, the patients will also receive a biometric shirt to use once every two weeks, to monitor their sleep during the study.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Continuous Positive Airway Pressure</intervention_name>
    <description>CPAP machine</description>
    <arm_group_label>Continuous Positive Airway Pressure</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Orthodontic intervention</intervention_name>
    <description>Mandibular advancement or Rapid maxillary expansion devices</description>
    <arm_group_label>Orthodontic Intervention</arm_group_label>
  </intervention>
  <biospec_retention>Samples Without DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Urine, blood and saliva&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Children from 6 to16 years old, from both sexes in Alberta, Canada, diagnosed with (a)&#xD;
        residual OSA (post-T&amp;A) or (b) diagnosed with OSA but for whom T&amp;A is not a treatment&#xD;
        option.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients diagnosed with obstructive sleep apnea by polysomnography who presented with&#xD;
             a failure in treatment with surgical removal of the tonsils and adenoid tissue&#xD;
             --adenotonsillectomy (T&amp;A).&#xD;
&#xD;
          -  Patients diagnosed with obstructive sleep apnea but for whom T&amp;A was not an option&#xD;
             following assessment by Otolaryngology.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Autism spectrum&#xD;
&#xD;
          -  Down syndrome&#xD;
&#xD;
          -  Pulmonary hypertension&#xD;
&#xD;
          -  Cystic fibrosis&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>6 Years</minimum_age>
    <maximum_age>16 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Giseon Heo</last_name>
    <role>Principal Investigator</role>
    <affiliation>Dentistry, University of Alberta</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Rochelle Young</last_name>
    <role>Study Chair</role>
    <affiliation>Pediatric Respiratory Medicine, University of Alberta Hospital</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Paul Major</last_name>
    <role>Study Director</role>
    <affiliation>Dentistry, University of Alberta</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Giseon Heo</last_name>
    <phone>1-780-885-0806</phone>
    <email>gheo@ualberta.ca</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Rochelle Young</last_name>
    <phone>1-780-407-2977</phone>
    <email>Rochelle.Young@albertahealthservices.ca</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Faculty of Medicine and Dentistry</name>
      <address>
        <city>Edmonton</city>
        <state>Alberta</state>
        <zip>T6G 2R7</zip>
        <country>Canada</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Rochelle Young</last_name>
      <phone>1-780-407-2977</phone>
      <email>Rochelle.Young@albertahealthservices.ca</email>
    </contact>
    <contact_backup>
      <last_name>Dory Sample</last_name>
      <phone>1-780-248-5599</phone>
      <email>Dory.Sample@albertahealthservices.ca</email>
    </contact_backup>
    <investigator>
      <last_name>Rochelle Young</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Carlos Flores-Mir</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Manuel Lagravere</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Paul Major</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Michael Major</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Diana Mager</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>January 2023</verification_date>
  <study_first_submitted>January 10, 2019</study_first_submitted>
  <study_first_submitted_qc>January 25, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 30, 2019</study_first_posted>
  <last_update_submitted>January 19, 2023</last_update_submitted>
  <last_update_submitted_qc>January 19, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">January 20, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Obstructive sleep apnea</keyword>
  <keyword>Children</keyword>
  <keyword>Orthodontic intervention</keyword>
  <keyword>Nutrition</keyword>
  <keyword>Metabolomic markers</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>Pediatric Obesity</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/NCT03821831
org study id: GHeo
nct id: NCT03821831
lead sponsor: 
collaborator: 
is fda regulated drug: No
is fda regulated device: Yes
is unapproved device: Yes
is us export: Yes
The aim of this study is to evaluate the potential improvement of sleep quality in children
      who have residual obstructive sleep apnea, using either an orthodontic intervention or
      continuous positive airway pressure (CPAP), versus no treatment.
Consenting patients and their parents will choose one of three options (within the context of
      medical/craniofacial appropriateness): CPAP, orthodontic intervention, or to remain untreated
      (control). It would be ideal if each patient was randomly assigned to one of three groups.
      However, in our study, random allocation is not an option as the established clinical
      pathways for treatment, financial resources, and physiological presentation of the patient
      determines the appropriate intervention. In each group, the effectiveness of the intervention
      will be analyzed through the evaluation of sleep parameters, medical history, questionnaire
      responses, craniofacial characteristics, diet, and metabolomic markers, each at baseline and
      at 12 months.
observational model: Cohort
time perspective: Prospective
measure: Measure of change in OSA severity
time frame: baseline and 12 months
description: Change from baseline Apnea-Hypopnea Index (OSA severity index) measurement by polysomnography at 12 months
measure: Change from baseline total score Pediatric Sleep Questionnaire (PSQ) at 12 months
time frame: baseline and 12 months
description: PSQ consists of total 22 questions with choices of answer; Yes or No. Yes answer will be coded as 1 and No answer coded as 0. Sum of 22 questions will be compared.
measure: Change from baseline body mass index (BMI) at 12 months
time frame: baseline and 12 months
description: Height (m) and weight (kg) will be measured to calculate BMI (kg/m^2).
arm group label: Continuous Positive Airway Pressure
description: This group consists of consenting patients and their parents who choose Continuous Positive Airway Pressure (CPAP). The CPAP is a type of therapy that applies mild air pressure to a person's upper airway to keep their airway open so that they can breathe normally while they sleep.
arm group label: Orthodontic Intervention
description: This group consists of consenting patients and their parents who choose orthodontic intervention will be seen by participating orthodontists who will determine types of orthodontic intervention; mandibular advancement devices or rapid maxillary expansion devices, or Class III mid face advancement with skeletal anchored headgear. In this group, the patients will also receive a biometric shirt to use once every two weeks, to monitor their sleep during the study.
arm group label: Control
description: This group consists of consenting patients and their parents who choose to remain untreated. In this group, the patients will also receive a biometric shirt to use once every two weeks, to monitor their sleep during the study.
intervention type: Device
intervention name: Continuous Positive Airway Pressure
description: CPAP machine
arm group label: Continuous Positive Airway Pressure
intervention type: Device
intervention name: Orthodontic intervention
description: Mandibular advancement or Rapid maxillary expansion devices
arm group label: Orthodontic Intervention
Urine, blood and saliva
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 6 Years
maximum age: 16 Years
healthy volunteers: No
last name: Giseon Heo
role: Principal Investigator
affiliation: Dentistry, University of Alberta
last name: Rochelle Young
role: Study Chair
affiliation: Pediatric Respiratory Medicine, University of Alberta Hospital
last name: Paul Major
role: Study Director
affiliation: Dentistry, University of Alberta
last name: Giseon Heo
phone: 1-780-885-0806
email: gheo@ualberta.ca
last name: Rochelle Young
phone: 1-780-407-2977
email: Rochelle.Young@albertahealthservices.ca
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
investigator: 
investigator: 
investigator: 
investigator: 
investigator: 
country: Canada
responsible party type: Sponsor
mesh term: Apnea
mesh term: Sleep Apnea Syndromes
mesh term: Sleep Apnea, Obstructive
mesh term: Pediatric Obesity