<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/NCT03267927</url>
  </required_header>
  <id_info>
    <org_study_id>35RC16_9851_SAOS</org_study_id>
    <nct_id>NCT03267927</nct_id>
  </id_info>
  <brief_title>Management of Obstructive Sleep Apnea (OSA) in Children and Maxillary and Mandibular Development</brief_title>
  <acronym>SAOS</acronym>
  <official_title>Management of Obstructive Sleep Apnea (OSA) in Children and Maxillary and Mandibular Development</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Rennes University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Rennes University Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Assessment of the association of maxillary expansion using a rapid palatal expansion, use of&#xD;
      a mandibular advancement appliance (MGA™) and of a device allowing sleep in a semi-seated&#xD;
      position (Yoobreath™) in patients with Obstructive Sleep Apnea (OAS). MGA™ and YooBreath™&#xD;
      constitute the Yookid system™.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Obstructive Sleep Apnea syndrome (OSA) shows a 10% morbidity rate in children with a higher&#xD;
      rate between the ages of 3 and 5. Generally speaking, its prevalence is underestimated.&#xD;
      Furthermore, detecting OSA remains difficult due to its particular physiopathology. The&#xD;
      decrease in nasopharyngeal airway dimensions is the most common etiology. This decrease is&#xD;
      related to soft tissues as well as maxillomandibular abnormalities. The aim of the study is&#xD;
      to show that reducing sleep apnea in children remains possible when inducing rapid palatal&#xD;
      expansion and mandibular advancement using the Yookid™ system. The Yookid™ system associates&#xD;
      a mandibular advancement appliance and repositioning of the patient during sleep.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 5, 2017</start_date>
  <completion_date type="Actual">March 25, 2019</completion_date>
  <primary_completion_date type="Actual">March 25, 2019</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Assessment in 5 to 7 year-old children the efficacy on OSA (removal or decrease of apnea/hypopnea) of Rapid Palatal Expansion combined with advancement using a mandibular advancement appliance (MGA™)</measure>
    <time_frame>Day 180</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Assessment in 5 to 7 year-old children the efficacy on OSA (removal or decrease of apnea/hypopnea) of Rapid Palatal Expansion combined with a device allowing a semi-seated sleeping position (YooBreath™)</measure>
    <time_frame>Day 180</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Sleep improvement</measure>
    <time_frame>Day -7, day 180</time_frame>
    <description>Measurement by polysomnography of desaturation index, micro arousal index and snoring index</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Assessment of quality of sleep</measure>
    <time_frame>Day 180</time_frame>
    <description>Assessment of quality of sleep by a questionnaire</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Assessment of quality of wakefulness</measure>
    <time_frame>Day 180</time_frame>
    <description>Assessment of quality of wakefulness by a questionnaire</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Measurement of lengthening of mandibular body and ramus</measure>
    <time_frame>Day -7, day 180</time_frame>
    <description>Assessment of mandible development by an orthodontist using cephalometric analysis</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Improvement of breathing</measure>
    <time_frame>Day -7, day 180</time_frame>
    <description>Improvement of breathing defined by polysomnography</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Assessment of dental occlusion</measure>
    <time_frame>Day -7, day 180</time_frame>
    <description>Assessment of dental occlusion (clinical and using casts): diagnosis of Angle class</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Assessement by the child and the parents of the treatment and the devices used</measure>
    <time_frame>Day 180</time_frame>
    <description>Assessement by the child and the parents of the treatment and the devices used by two questionnaires (one for parents and one for the child)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Assessment of intensity of pain during rapid palatal expansion</measure>
    <time_frame>Day 60</time_frame>
    <description>Assessment of intensity of pain after fixing of rapid palatal expansion using a Visual Analogue Scale (VAS)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Assessment of duration of pain during rapid palatal expansion</measure>
    <time_frame>Day 60</time_frame>
    <description>Number of painful days after fixing of rapid palatal expansion</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Assessment of intensity of dental pain the morning on waking after using the MGA™ system</measure>
    <time_frame>Day 60, day 90, day 120, day 150, day 180</time_frame>
    <description>Assessment of intensity of dental pain the morning on waking using a Visual Analogue Scale (VAS)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Assessment of salivary disorders the morning on waking after using the MGA™ system</measure>
    <time_frame>Day 60, day 90, day 120, day 150, day 180</time_frame>
    <description>Assessment of salivary disorders the morning on waking by a questionnaire</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Assessment of duration of dental pain the morning on waking after using the MGA™ system</measure>
    <time_frame>Day 60, day 90, day 120, day 150, day 180</time_frame>
    <description>Number of painful days at the mandible the morning on waking</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Assessment of pain related to the semi-seated position</measure>
    <time_frame>Day 15, day 60, day 90, day 120, day 150, day 180</time_frame>
    <description>Assessment of pain related to the semi-seated position using a Visual Analogue Scale (VAS)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Assessment of disorders in falling asleep and sleep quality (micro arousals)</measure>
    <time_frame>Day 15, day 60, day 90, day 120, day 150, day 180</time_frame>
    <description>Assessment of disorders in falling asleep and sleep quality (micro arousals) by a questionnaire</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Assessment of risk of falling using the Yoobreath system™</measure>
    <time_frame>Day 15, day 60, day 90, day 120, day 150, day 180</time_frame>
    <description>Number of falls</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Assessment of the compliance</measure>
    <time_frame>Day 0, day 15, day 60, day 90, day 120, day 150, day 180</time_frame>
    <description>Reporting of side effects</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">4</enrollment>
  <condition>Obstructive Sleep Apnea Syndrome</condition>
  <arm_group>
    <arm_group_label>Patient with OSA</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Rapid palatal expansion</intervention_name>
    <description>Fixation of rapid palatal expansion from day 0 to day 60</description>
    <arm_group_label>Patient with OSA</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>MGA™ system</intervention_name>
    <description>Use of a mandibular advancement Appliance during the night from day 60 to day 180 (end of treatment from day 120 if Angle Class I is obtained)</description>
    <arm_group_label>Patient with OSA</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Yoobreath™ system</intervention_name>
    <description>Use of a device allowing sleep in a semi-seated position during the night from day 15 to day 180 (end of treatment from day 120 if Angle Class I is obtained)</description>
    <arm_group_label>Patient with OSA</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  5 to 7 year-old children&#xD;
&#xD;
          -  Children with American Society of Anesthesiologists score (ASA) of 1 and 2&#xD;
&#xD;
          -  Children with signs of OSA during examination and clinical exam&#xD;
&#xD;
          -  Children with apnea-hypopnea index (AHI) from 1 to 5 (one to five sleep apnea / hour&#xD;
             during PSG)&#xD;
&#xD;
          -  Children with a class II division 1 angle malocclusion (at the canines level rotation&#xD;
             center) and skeletal class II according to Delaire analysis&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  OSA associated to syndromic disorder and/or syndrome&#xD;
&#xD;
          -  Body/Mass Index (BMI) &gt; 97ème percentile according to development curves (obese&#xD;
             children)&#xD;
&#xD;
          -  Central sleep apnea&#xD;
&#xD;
          -  Respiratory allergy&#xD;
&#xD;
          -  Previous ear, nose and throat (ENT) surgery&#xD;
&#xD;
          -  Hypertrophic tonsils needing surgery&#xD;
&#xD;
          -  Adenoid hypertrophy needing surgery&#xD;
&#xD;
          -  Patients with ankyloglossia&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>5 Years</minimum_age>
    <maximum_age>7 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>CHU de Rennes</name>
      <address>
        <city>Rennes</city>
        <zip>35033</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>February 2020</verification_date>
  <study_first_submitted>August 28, 2017</study_first_submitted>
  <study_first_submitted_qc>August 28, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 31, 2017</study_first_posted>
  <last_update_submitted>February 6, 2020</last_update_submitted>
  <last_update_submitted_qc>February 6, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">February 7, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>OSA</keyword>
  <keyword>Polysomnography</keyword>
  <keyword>Rapid palatal expansion</keyword>
  <keyword>Mandibular advancement</keyword>
  <keyword>Sleep position</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>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03267927
org study id: 35RC16_9851_SAOS
nct id: NCT03267927
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Assessment of the association of maxillary expansion using a rapid palatal expansion, use of
      a mandibular advancement appliance (MGA™) and of a device allowing sleep in a semi-seated
      position (Yoobreath™) in patients with Obstructive Sleep Apnea (OAS). MGA™ and YooBreath™
      constitute the Yookid system™.
Obstructive Sleep Apnea syndrome (OSA) shows a 10% morbidity rate in children with a higher
      rate between the ages of 3 and 5. Generally speaking, its prevalence is underestimated.
      Furthermore, detecting OSA remains difficult due to its particular physiopathology. The
      decrease in nasopharyngeal airway dimensions is the most common etiology. This decrease is
      related to soft tissues as well as maxillomandibular abnormalities. The aim of the study is
      to show that reducing sleep apnea in children remains possible when inducing rapid palatal
      expansion and mandibular advancement using the Yookid™ system. The Yookid™ system associates
      a mandibular advancement appliance and repositioning of the patient during sleep.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Assessment in 5 to 7 year-old children the efficacy on OSA (removal or decrease of apnea/hypopnea) of Rapid Palatal Expansion combined with advancement using a mandibular advancement appliance (MGA™)
time frame: Day 180
measure: Assessment in 5 to 7 year-old children the efficacy on OSA (removal or decrease of apnea/hypopnea) of Rapid Palatal Expansion combined with a device allowing a semi-seated sleeping position (YooBreath™)
time frame: Day 180
measure: Sleep improvement
time frame: Day -7, day 180
description: Measurement by polysomnography of desaturation index, micro arousal index and snoring index
measure: Assessment of quality of sleep
time frame: Day 180
description: Assessment of quality of sleep by a questionnaire
measure: Assessment of quality of wakefulness
time frame: Day 180
description: Assessment of quality of wakefulness by a questionnaire
measure: Measurement of lengthening of mandibular body and ramus
time frame: Day -7, day 180
description: Assessment of mandible development by an orthodontist using cephalometric analysis
measure: Improvement of breathing
time frame: Day -7, day 180
description: Improvement of breathing defined by polysomnography
measure: Assessment of dental occlusion
time frame: Day -7, day 180
description: Assessment of dental occlusion (clinical and using casts): diagnosis of Angle class
measure: Assessement by the child and the parents of the treatment and the devices used
time frame: Day 180
description: Assessement by the child and the parents of the treatment and the devices used by two questionnaires (one for parents and one for the child)
measure: Assessment of intensity of pain during rapid palatal expansion
time frame: Day 60
description: Assessment of intensity of pain after fixing of rapid palatal expansion using a Visual Analogue Scale (VAS)
measure: Assessment of duration of pain during rapid palatal expansion
time frame: Day 60
description: Number of painful days after fixing of rapid palatal expansion
measure: Assessment of intensity of dental pain the morning on waking after using the MGA™ system
time frame: Day 60, day 90, day 120, day 150, day 180
description: Assessment of intensity of dental pain the morning on waking using a Visual Analogue Scale (VAS)
measure: Assessment of salivary disorders the morning on waking after using the MGA™ system
time frame: Day 60, day 90, day 120, day 150, day 180
description: Assessment of salivary disorders the morning on waking by a questionnaire
measure: Assessment of duration of dental pain the morning on waking after using the MGA™ system
time frame: Day 60, day 90, day 120, day 150, day 180
description: Number of painful days at the mandible the morning on waking
measure: Assessment of pain related to the semi-seated position
time frame: Day 15, day 60, day 90, day 120, day 150, day 180
description: Assessment of pain related to the semi-seated position using a Visual Analogue Scale (VAS)
measure: Assessment of disorders in falling asleep and sleep quality (micro arousals)
time frame: Day 15, day 60, day 90, day 120, day 150, day 180
description: Assessment of disorders in falling asleep and sleep quality (micro arousals) by a questionnaire
measure: Assessment of risk of falling using the Yoobreath system™
time frame: Day 15, day 60, day 90, day 120, day 150, day 180
description: Number of falls
measure: Assessment of the compliance
time frame: Day 0, day 15, day 60, day 90, day 120, day 150, day 180
description: Reporting of side effects
arm group label: Patient with OSA
arm group type: Experimental
intervention type: Device
intervention name: Rapid palatal expansion
description: Fixation of rapid palatal expansion from day 0 to day 60
arm group label: Patient with OSA
intervention type: Device
intervention name: MGA™ system
description: Use of a mandibular advancement Appliance during the night from day 60 to day 180 (end of treatment from day 120 if Angle Class I is obtained)
arm group label: Patient with OSA
intervention type: Device
intervention name: Yoobreath™ system
description: Use of a device allowing sleep in a semi-seated position during the night from day 15 to day 180 (end of treatment from day 120 if Angle Class I is obtained)
arm group label: Patient with OSA
criteria: 
gender: All
minimum age: 5 Years
maximum age: 7 Years
healthy volunteers: No
facility: 
country: France
responsible party type: Sponsor
mesh term: Apnea
mesh term: Sleep Apnea Syndromes
mesh term: Sleep Apnea, Obstructive
sharing ipd: No