<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/NCT01666886</url>
  </required_header>
  <id_info>
    <org_study_id>EC 12/30/243</org_study_id>
    <nct_id>NCT01666886</nct_id>
  </id_info>
  <brief_title>Efficacy of Additional Titration During Oral Appliance Treatment for Sleep-disordered Breathing.</brief_title>
  <official_title>Efficacy of Additional Titration During Oral Appliance Treatment for Sleep-disordered Breathing.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Antwerp</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Hospital, Antwerp</source>
  <brief_summary>
    <textblock>
      In the protocol &quot;Predicting therapeutic outcome of mandibular advancement device treatment in&#xD;
      obstructive sleep apnea (PROMAD)&quot;, 100 patients with obstructive sleep apnea are included and&#xD;
      started MAD treatment at 75% of maximal protrusion. All patients underwent polysomnography&#xD;
      with MAD in situ to evaluate the effect of the MAD on severity of sleep apnea. If the results&#xD;
      of the polysomnography with MAD are unsuccessful (defined as a reduction in AHI with the MAD&#xD;
      in situ of less than 50% compared to baseline), the therapy needs to be adjusted. Finding the&#xD;
      most effective protrusion should be a weighted compromise between efficacy and side-effects&#xD;
      of MAD therapy.&#xD;
&#xD;
      In patients with insufficient results on the polysomnography with the MAD at 75% of maximal&#xD;
      protrusion, the MAD will be further adjusted until 90% of the maximal protrusion measured at&#xD;
      the follow-up visit after the polysomnography with the MAD. After habituation and adaptation&#xD;
      period but within 2 months after the first polysomnography with MAD, a new polysomnography&#xD;
      will be performed to assess the effect of the 90% protruded position.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 2012</start_date>
  <completion_date type="Actual">April 2015</completion_date>
  <primary_completion_date type="Actual">April 2015</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>Polysomnographic efficacy</measure>
    <time_frame>3 to 6 months after start of therapy</time_frame>
    <description>Polysomnographic re-evaluation of the severity of sleep apnea (apnea/hypopnea index).</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">20</enrollment>
  <condition>Obstructive Sleep Apnea Syndrome</condition>
  <arm_group>
    <arm_group_label>Mandibular Advancement Device (MAD)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Mandibular advancement during therapy with a mandibular advancement device (MAD) in 90% of maximal protrusion</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Mandibular Advancement Device (MAD)</intervention_name>
    <arm_group_label>Mandibular Advancement Device (MAD)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age ≥ 18 years&#xD;
&#xD;
          -  Body Mass Index (BMI) ≤ 35 kg/m²&#xD;
&#xD;
          -  OSAS, as defined by the American Academy of Sleep Medicine Task Force&#xD;
&#xD;
          -  apnea-hypopnea index (AHI) &lt; 50&#xD;
&#xD;
          -  incomplete elimination of apneas and/or hypopnea during therapy with mandibular&#xD;
             advancement device in 75% of maximal protrusion&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Other sleep disorders (i.e. parasomnias)&#xD;
&#xD;
          -  Invasive upper airway surgery for sleep-disordered breathing&#xD;
&#xD;
          -  Known genetic disorders with craniofacial and/or upper airway malformations&#xD;
&#xD;
          -  Use of benzodiazepine and/or antidepressants&#xD;
&#xD;
          -  Known history of psychiatric disease&#xD;
&#xD;
          -  Known history of fibromyalgia and/or chronic fatigue syndrome&#xD;
&#xD;
          -  Dental contra-indications: functional restrictions of the temporomandibular joint,&#xD;
             insufficient dentition with pathological changes, insufficient retention for MAD use&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Antwerp University Hospital</name>
      <address>
        <city>Wilrijk</city>
        <state>Antwerp</state>
        <zip>2650</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Belgium</country>
  </location_countries>
  <verification_date>January 2021</verification_date>
  <study_first_submitted>August 14, 2012</study_first_submitted>
  <study_first_submitted_qc>August 15, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 16, 2012</study_first_posted>
  <last_update_submitted>January 15, 2021</last_update_submitted>
  <last_update_submitted_qc>January 15, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">January 20, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University Hospital, Antwerp</investigator_affiliation>
    <investigator_full_name>ethisch.comite@uza.be</investigator_full_name>
    <investigator_title>Ethics Committee Antwerp Univerity Hospital</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Sleep Apnea Syndromes</mesh_term>
    <mesh_term>Sleep Apnea, Obstructive</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/NCT01666886
org study id: EC 12/30/243
nct id: NCT01666886
lead sponsor: 
In the protocol "Predicting therapeutic outcome of mandibular advancement device treatment in
      obstructive sleep apnea (PROMAD)", 100 patients with obstructive sleep apnea are included and
      started MAD treatment at 75% of maximal protrusion. All patients underwent polysomnography
      with MAD in situ to evaluate the effect of the MAD on severity of sleep apnea. If the results
      of the polysomnography with MAD are unsuccessful (defined as a reduction in AHI with the MAD
      in situ of less than 50% compared to baseline), the therapy needs to be adjusted. Finding the
      most effective protrusion should be a weighted compromise between efficacy and side-effects
      of MAD therapy.

      In patients with insufficient results on the polysomnography with the MAD at 75% of maximal
      protrusion, the MAD will be further adjusted until 90% of the maximal protrusion measured at
      the follow-up visit after the polysomnography with the MAD. After habituation and adaptation
      period but within 2 months after the first polysomnography with MAD, a new polysomnography
      will be performed to assess the effect of the 90% protruded position.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Polysomnographic efficacy
time frame: 3 to 6 months after start of therapy
description: Polysomnographic re-evaluation of the severity of sleep apnea (apnea/hypopnea index).
arm group label: Mandibular Advancement Device (MAD)
arm group type: Experimental
description: Mandibular advancement during therapy with a mandibular advancement device (MAD) in 90% of maximal protrusion
intervention type: Device
intervention name: Mandibular Advancement Device (MAD)
arm group label: Mandibular Advancement Device (MAD)
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: Belgium
responsible party type: Principal Investigator
investigator affiliation: University Hospital, Antwerp
investigator full name: ethisch.comite@uza.be
investigator title: Ethics Committee Antwerp Univerity Hospital
mesh term: Sleep Apnea Syndromes
mesh term: Sleep Apnea, Obstructive