<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/NCT03246477</url>
  </required_header>
  <id_info>
    <org_study_id>2016/0876</org_study_id>
    <nct_id>NCT03246477</nct_id>
  </id_info>
  <brief_title>Long-term Impact of Maxillomandibular Advancement Osteotomy on Sleep Apnea Patients</brief_title>
  <acronym>MIMOSA</acronym>
  <official_title>Evaluation of the Long-term Impact of Maxillomandibular Advancement Osteotomy on Patients With Obstructive Sleep Apnea Syndrome</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>AZ Sint-Jan AV</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University Hospital, Ghent</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>AZ Sint-Jan AV</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>
      Background Maxillomandibular advancement surgery (MMA) has demonstrated high success rates,&#xD;
      improving both the apnea-hypopnea index and associated patient' quality of life (QOL), in&#xD;
      patients diagnosed with obstructive sleep apnea syndrome (OSAS). However, clinical relapse&#xD;
      has been described in the target population, especially when associated with significant&#xD;
      weight gain. Literature reporting the long-term impact of MMA for OSAS is lacking. The&#xD;
      surgeons of the Division of Maxillofacial Surgery already started to perform this type of&#xD;
      surgery in 1995.&#xD;
&#xD;
      Objectives The investigators aim to evaluate the long-term (minimum 15 years post-surgery)&#xD;
      biologic and QOL impact of MMA in patients with OSAS. The biologic impact refers to the&#xD;
      stability of hard and soft tissues and polysomnographic results.&#xD;
&#xD;
      Study design Retrospective study Both pre- en postoperative clinical imaging, polysomnography&#xD;
      and quality of life questionnaires will be retrieved from all patients that were surgically&#xD;
      treated with an MMA by one surgeon (CDC) between 01/11/1995 and 01/12/1999.&#xD;
&#xD;
      Conclusion Short-term data have shown high success rates for MMA in OSAS patients. However,&#xD;
      long-term data are lacking. This retrospective study might provide us with more information&#xD;
      about the incidence of clinical relapse fifteen to twenty years after surgery.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 2016</start_date>
  <completion_date type="Actual">December 31, 2017</completion_date>
  <primary_completion_date type="Actual">December 31, 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>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>apnea-hypopnea index, as determined through polysomnography</measure>
    <time_frame>minimum 15 years postoperative</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>oxygen saturation values, as determined through polysomnography</measure>
    <time_frame>minimum 15 years postoperative</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>evolution of patient quality of life, through Epworth Sleepiness Scale</measure>
    <time_frame>preoperative</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Stability of hard and soft head and neck tissue, according to manual anthropometry</measure>
    <time_frame>min 15 years postoperative</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evolution of apnea-hypopnea index, as determined through polysomnography</measure>
    <time_frame>preoperative</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evolution of apnea-hypopnea index, as determined through polysomnography</measure>
    <time_frame>immediately postoperative</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>oxygen saturation values, as determined through polysomnography</measure>
    <time_frame>preoperative</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>oxygen saturation values, as determined through polysomnography</measure>
    <time_frame>immediately postoperative</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>evolution of patient quality of life, through Epworth Sleepiness Scale</measure>
    <time_frame>immediately postoperative</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>evolution of patient quality of life, through Epworth Sleepiness Scale</measure>
    <time_frame>minimum 15 years postoperative</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>evolution of patient quality of life, through OSAS questionnaire</measure>
    <time_frame>preoperative</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>evolution of patient quality of life, through OSAS questionnaire</measure>
    <time_frame>immediately postoperative</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>evolution of patient quality of life, through OSAS questionnaire</measure>
    <time_frame>minimum 15 years postoperative</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>evaluation of hard and soft head and neck tissue, according to cone-beam CT imaging</measure>
    <time_frame>minimum 15 years postoperative</time_frame>
  </secondary_outcome>
  <enrollment type="Actual">12</enrollment>
  <condition>Obstructive Sleep Apnea</condition>
  <eligibility>
    <study_pop>
      <textblock>
        All patients (n=10/12) with a clinically confirmed diagnosis of OSAS, that were treated&#xD;
        with an MMA between 01/11/1995 and 01/12/1999 by one surgeon (CDC)&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  clinically confirmed diagnosis of OSAS&#xD;
&#xD;
          -  treated with an MMA between 01/11/1995 and 01/12/1999 by one surgeon (CDC)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  not following abovementioned criteria&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Nathalie Neyt</last_name>
    <role>Principal Investigator</role>
    <affiliation>AZ Sint-Jan Brugge-Oostende AV</affiliation>
  </overall_official>
  <verification_date>February 2019</verification_date>
  <study_first_submitted>February 10, 2017</study_first_submitted>
  <study_first_submitted_qc>August 7, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 11, 2017</study_first_posted>
  <last_update_submitted>February 13, 2019</last_update_submitted>
  <last_update_submitted_qc>February 13, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">February 15, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>AZ Sint-Jan AV</investigator_affiliation>
    <investigator_full_name>Nathalie Neyt</investigator_full_name>
    <investigator_title>maxillofacial surgeon, principal investigator</investigator_title>
  </responsible_party>
  <keyword>maxillomandibular advancement osteotomy</keyword>
  <keyword>long-term results</keyword>
  <keyword>quality of life</keyword>
  <keyword>polysomnographic measurements</keyword>
  <keyword>skeletal stability</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/NCT03246477
org study id: 2016/0876
nct id: NCT03246477
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Background Maxillomandibular advancement surgery (MMA) has demonstrated high success rates,
      improving both the apnea-hypopnea index and associated patient' quality of life (QOL), in
      patients diagnosed with obstructive sleep apnea syndrome (OSAS). However, clinical relapse
      has been described in the target population, especially when associated with significant
      weight gain. Literature reporting the long-term impact of MMA for OSAS is lacking. The
      surgeons of the Division of Maxillofacial Surgery already started to perform this type of
      surgery in 1995.

      Objectives The investigators aim to evaluate the long-term (minimum 15 years post-surgery)
      biologic and QOL impact of MMA in patients with OSAS. The biologic impact refers to the
      stability of hard and soft tissues and polysomnographic results.

      Study design Retrospective study Both pre- en postoperative clinical imaging, polysomnography
      and quality of life questionnaires will be retrieved from all patients that were surgically
      treated with an MMA by one surgeon (CDC) between 01/11/1995 and 01/12/1999.

      Conclusion Short-term data have shown high success rates for MMA in OSAS patients. However,
      long-term data are lacking. This retrospective study might provide us with more information
      about the incidence of clinical relapse fifteen to twenty years after surgery.
observational model: Cohort
time perspective: Retrospective
measure: apnea-hypopnea index, as determined through polysomnography
time frame: minimum 15 years postoperative
measure: oxygen saturation values, as determined through polysomnography
time frame: minimum 15 years postoperative
measure: evolution of patient quality of life, through Epworth Sleepiness Scale
time frame: preoperative
measure: Stability of hard and soft head and neck tissue, according to manual anthropometry
time frame: min 15 years postoperative
measure: Evolution of apnea-hypopnea index, as determined through polysomnography
time frame: preoperative
measure: Evolution of apnea-hypopnea index, as determined through polysomnography
time frame: immediately postoperative
measure: oxygen saturation values, as determined through polysomnography
time frame: preoperative
measure: oxygen saturation values, as determined through polysomnography
time frame: immediately postoperative
measure: evolution of patient quality of life, through Epworth Sleepiness Scale
time frame: immediately postoperative
measure: evolution of patient quality of life, through Epworth Sleepiness Scale
time frame: minimum 15 years postoperative
measure: evolution of patient quality of life, through OSAS questionnaire
time frame: preoperative
measure: evolution of patient quality of life, through OSAS questionnaire
time frame: immediately postoperative
measure: evolution of patient quality of life, through OSAS questionnaire
time frame: minimum 15 years postoperative
measure: evaluation of hard and soft head and neck tissue, according to cone-beam CT imaging
time frame: minimum 15 years postoperative
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Nathalie Neyt
role: Principal Investigator
affiliation: AZ Sint-Jan Brugge-Oostende AV
responsible party type: Principal Investigator
investigator affiliation: AZ Sint-Jan AV
investigator full name: Nathalie Neyt
investigator title: maxillofacial surgeon, principal investigator
mesh term: Apnea
mesh term: Sleep Apnea Syndromes
mesh term: Sleep Apnea, Obstructive
sharing ipd: No