xml: <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/NCT06022679</url>
    </required_header>
    <id_info>
      <org_study_id>B7072022000010</org_study_id>
      <secondary_id>2022/72</secondary_id>
      <nct_id>NCT06022679</nct_id>
    </id_info>
    <brief_title>CBCT Analysis of the Craniofacial Architecture in Young, Non-overweight Apneic Adult Phenotype</brief_title>
    <acronym>ACAS-3D</acronym>
    <official_title>CBCT Analysis of the Craniofacial Architecture in Young, Non-overweight Apneic Adult Phenotype</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Centre Hospitalier Universitaire de Liege</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Centre Hospitalier Universitaire de Liege</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>
        This prospective, controlled study will compare the 3D cephalometric analysis of bone and&#xD;
        craniofacial soft tissues in young (18-35 years) non-overweight apneic adults phenotype&#xD;
        between a test group (with AHI 15) and a control group (healthy subjects with AHI &lt; 15).&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Objectives The goal of this study is to determine an accurate bone and soft tissue phenotype&#xD;
        for the non-overweight apneic young adult.&#xD;
  &#xD;
        Materials and Methods This study was approved by the ethics medical committee of the&#xD;
        University hospital of Liege.&#xD;
  &#xD;
        This prospective, controlled study will compare cephalometric 3D analysis of bone and&#xD;
        craniofacial soft tissue phenotype of young, non-overweight apneic adults using cephalometric&#xD;
        3D analysis between a test group (with AHI 15) and a control group (healthy subjects with AHI&#xD;
        &lt; 15).&#xD;
  &#xD;
        The inclusion criteria were : (1) patients aged between 18 and 35 years ; (2) Body Mass Index&#xD;
        (BMI) lower than 30kg/m² ; (3) alcohol consumption less than 4 unit per day ; (4) tabacco use&#xD;
        less than 6 cigarettes per day ; (5) no illicit drug use ; and (6) absence of chronic&#xD;
        pathology or medication.&#xD;
  &#xD;
        The exclusion criteria were : (1) presence of an acute illness on the day of admission ; (2)&#xD;
        patients treated with orthognathic surgery after apnea screening ; (3) patients with&#xD;
        polysomnography with a sleep treatment device (PPCN or Mandibular advancement device).&#xD;
  &#xD;
        The test group consisted of 23 patients (9 girls and 14 boys) recruited in polysomnography in&#xD;
        sleep center of CHU Liege for suspected sleep disorders between 1 january 2022 and 1 april&#xD;
        2023.&#xD;
  &#xD;
        Concerning the control group, the participants, healthy adults volunteers are recruited among&#xD;
        friends and families of students who collaborate with sleep center for scientific projects.&#xD;
        These subjects have no complaints related to OSA and will have to undergo a sleep examination&#xD;
        (ventilatory polygraphy) to certify the absence of OSA. This group consisted of 23 patients&#xD;
        (14 girls and 9 boys).&#xD;
  &#xD;
        This study takes place in two stages. First, all patient are invited to an initial&#xD;
        consultation where question about demographics (age, weight, height, gender) and medical&#xD;
        history will be asked. At the end of this consultation, only patient of the control group&#xD;
        leave with a sleep monitor to record their sleep for one night.&#xD;
  &#xD;
        Afterwards, all patients (test and control group) will be invited to undergo a super low dose&#xD;
        CBCT in the supine position at CHU Sart Tilman University Hospital.&#xD;
  &#xD;
        Demographics and orthodontics data A general history will be taken, including gender, age,&#xD;
        height, weight, medical and surgical history (e.g. presence/absence of tonsils and&#xD;
        vegetations), current or past regular medication use, presence of allergies associated with&#xD;
        allergic rhinitis, presence of asthma and presence of parafunctions.&#xD;
  &#xD;
        Cephalometric data An ultra low dose CBCT ( 300μm resolution) will be performed in each&#xD;
        patient with a field of 16x18 cm. A computerized 3D analysis will be performed with Dolphin&#xD;
        Imaging 11.95 software. All these tools will allow the collection of the following data:&#xD;
        parameters concerning the morphological typology and growth potential, the base of the skull,&#xD;
        the maxilla, the mandible, the inter-maxillary relationship, the pharynx, the airways as well&#xD;
        as the volumes of the different structures.&#xD;
  &#xD;
        Sleep data The data will be collected by means of the epworth sleepiness scale (ESS) and a&#xD;
        sleep recording of the polysomnography at the hospital type (AASM type 1 sleep recording) for&#xD;
        the test group and of the ventilatory polygraph type (AASM type 3 sleep recording) for the&#xD;
        control group.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">April 1, 2022</start_date>
    <completion_date type="Actual">April 1, 2023</completion_date>
    <primary_completion_date type="Actual">April 1, 2023</primary_completion_date>
    <study_type>Observational</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Other</observational_model>
      <time_perspective>Other</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>maxillary volume</measure>
      <time_frame>2month</time_frame>
      <description>maxillary volume with 3D cephalométric analysis</description>
    </primary_outcome>
    <number_of_groups>2</number_of_groups>
    <enrollment type="Actual">46</enrollment>
    <condition>OSA</condition>
    <arm_group>
      <arm_group_label>Test group SAHOS</arm_group_label>
      <description>The test group consisted of 23 patients ( 9 girls and 14 boys) recruited on the basis of polysomnography at sleep center of CHU Liege for suspected sleep disorders between 1 january 2022 and 1 april 2023, with IAH &gt;15</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Control group no SAHOS</arm_group_label>
      <description>Concerning the control group, the participants, adults volunteers are recruited among friends and families of students who collaborate with sleep center for scientific projects. These subjects have no complaints related to OSA and will have to undergo a sleep examination (ventilatory polygraphy) to certify the absence of OSA. This group consisted of 23 patients (14 girls and 9 boys).</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>CBCT</intervention_name>
      <description>CBCT examination in supine position A computerized 3D-analysis using Dolphin Imaging 11.95 software was performed in each CBCT.</description>
      <arm_group_label>Control group no SAHOS</arm_group_label>
      <arm_group_label>Test group SAHOS</arm_group_label>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          Young people (18-35 years) non-overweight apneic divided into 2 groups: a test group (with&#xD;
          AHI 15) and a control group (healthy subjects with AHI &lt; 15).&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  (1) patients aged between 18 and 35 years ;&#xD;
  &#xD;
            -  (2) Body Mass Index (BMI) lower than 30kg/m² ;&#xD;
  &#xD;
            -  (3) alcohol consumption less than 4 unit per day ;&#xD;
  &#xD;
            -  (4) tabacco use less than 6 cigarettes per day ;&#xD;
  &#xD;
            -  (5) no illicit drug use ; and&#xD;
  &#xD;
            -  (6) absence of chronic pathology or medication.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  (1) presence of an acute illness on the day of admission ;&#xD;
  &#xD;
            -  (2) patients treated with orthognathic surgery after apnea screening ;&#xD;
  &#xD;
            -  (3) patients with polysomnography with a sleep treatment device (PPCN or Mandibular&#xD;
               advancement device).&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>35 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Annick AB Bruwier</last_name>
      <role>Study Director</role>
      <affiliation>Service d'orthopédie dento-faciale CHU Liège</affiliation>
    </overall_official>
    <overall_official>
      <last_name>mathilde jadoul</last_name>
      <role>Principal Investigator</role>
      <affiliation>Service Orthopédie dento-faciale CHU Liege</affiliation>
    </overall_official>
    <location>
      <facility>
        <name>CHU Liège, site Brull</name>
        <address>
          <city>Liège</city>
          <zip>4020</zip>
          <country>Belgium</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Belgium</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 16, 2023</study_first_submitted>
    <study_first_submitted_qc>August 31, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 5, 2023</study_first_posted>
    <last_update_submitted>August 31, 2023</last_update_submitted>
    <last_update_submitted_qc>August 31, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 5, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Centre Hospitalier Universitaire de Liege</investigator_affiliation>
      <investigator_full_name>Jadoul Mathilde</investigator_full_name>
      <investigator_title>post graduated dento facial orthopedic department</investigator_title>
    </responsible_party>
    <keyword>Young no-overweight adult</keyword>
    <keyword>OSA</keyword>
    <keyword>cephalometry</keyword>
    <keyword>3D</keyword>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06022679
  org study id: B7072022000010
  secondary id: 2022/72
  nct id: NCT06022679
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  This prospective, controlled study will compare the 3D cephalometric analysis of bone and
        craniofacial soft tissues in young (18-35 years) non-overweight apneic adults phenotype
        between a test group (with AHI 15) and a control group (healthy subjects with AHI < 15).
  Objectives The goal of this study is to determine an accurate bone and soft tissue phenotype
        for the non-overweight apneic young adult.
  
        Materials and Methods This study was approved by the ethics medical committee of the
        University hospital of Liege.
  
        This prospective, controlled study will compare cephalometric 3D analysis of bone and
        craniofacial soft tissue phenotype of young, non-overweight apneic adults using cephalometric
        3D analysis between a test group (with AHI 15) and a control group (healthy subjects with AHI
        < 15).
  
        The inclusion criteria were : (1) patients aged between 18 and 35 years ; (2) Body Mass Index
        (BMI) lower than 30kg/m² ; (3) alcohol consumption less than 4 unit per day ; (4) tabacco use
        less than 6 cigarettes per day ; (5) no illicit drug use ; and (6) absence of chronic
        pathology or medication.
  
        The exclusion criteria were : (1) presence of an acute illness on the day of admission ; (2)
        patients treated with orthognathic surgery after apnea screening ; (3) patients with
        polysomnography with a sleep treatment device (PPCN or Mandibular advancement device).
  
        The test group consisted of 23 patients (9 girls and 14 boys) recruited in polysomnography in
        sleep center of CHU Liege for suspected sleep disorders between 1 january 2022 and 1 april
        2023.
  
        Concerning the control group, the participants, healthy adults volunteers are recruited among
        friends and families of students who collaborate with sleep center for scientific projects.
        These subjects have no complaints related to OSA and will have to undergo a sleep examination
        (ventilatory polygraphy) to certify the absence of OSA. This group consisted of 23 patients
        (14 girls and 9 boys).
  
        This study takes place in two stages. First, all patient are invited to an initial
        consultation where question about demographics (age, weight, height, gender) and medical
        history will be asked. At the end of this consultation, only patient of the control group
        leave with a sleep monitor to record their sleep for one night.
  
        Afterwards, all patients (test and control group) will be invited to undergo a super low dose
        CBCT in the supine position at CHU Sart Tilman University Hospital.
  
        Demographics and orthodontics data A general history will be taken, including gender, age,
        height, weight, medical and surgical history (e.g. presence/absence of tonsils and
        vegetations), current or past regular medication use, presence of allergies associated with
        allergic rhinitis, presence of asthma and presence of parafunctions.
  
        Cephalometric data An ultra low dose CBCT ( 300μm resolution) will be performed in each
        patient with a field of 16x18 cm. A computerized 3D analysis will be performed with Dolphin
        Imaging 11.95 software. All these tools will allow the collection of the following data:
        parameters concerning the morphological typology and growth potential, the base of the skull,
        the maxilla, the mandible, the inter-maxillary relationship, the pharynx, the airways as well
        as the volumes of the different structures.
  
        Sleep data The data will be collected by means of the epworth sleepiness scale (ESS) and a
        sleep recording of the polysomnography at the hospital type (AASM type 1 sleep recording) for
        the test group and of the ventilatory polygraph type (AASM type 3 sleep recording) for the
        control group.
  observational model: Other
  time perspective: Other
  measure: maxillary volume
  time frame: 2month
  description: maxillary volume with 3D cephalométric analysis
  arm group label: Test group SAHOS
  description: The test group consisted of 23 patients ( 9 girls and 14 boys) recruited on the basis of polysomnography at sleep center of CHU Liege for suspected sleep disorders between 1 january 2022 and 1 april 2023, with IAH >15
  arm group label: Control group no SAHOS
  description: Concerning the control group, the participants, adults volunteers are recruited among friends and families of students who collaborate with sleep center for scientific projects. These subjects have no complaints related to OSA and will have to undergo a sleep examination (ventilatory polygraphy) to certify the absence of OSA. This group consisted of 23 patients (14 girls and 9 boys).
  intervention type: Other
  intervention name: CBCT
  description: CBCT examination in supine position A computerized 3D-analysis using Dolphin Imaging 11.95 software was performed in each CBCT.
  arm group label: Control group no SAHOS
  arm group label: Test group SAHOS
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 35 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Annick AB Bruwier
  role: Study Director
  affiliation: Service d'orthopédie dento-faciale CHU Liège
  last name: mathilde jadoul
  role: Principal Investigator
  affiliation: Service Orthopédie dento-faciale CHU Liege
  facility: 
  country: Belgium
  responsible party type: Principal Investigator
  investigator affiliation: Centre Hospitalier Universitaire de Liege
  investigator full name: Jadoul Mathilde
  investigator title: post graduated dento facial orthopedic department