<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/NCT03299023</url>
  </required_header>
  <id_info>
    <org_study_id>R8-1648</org_study_id>
    <nct_id>NCT03299023</nct_id>
  </id_info>
  <brief_title>The Effect of Tooth Position During Orthodontic Treatment on the Apnea/ Hypopnea Index (AHI)</brief_title>
  <official_title>The Effect of Tooth Position During Orthodontic Treatment on the Apnea/ Hypopnea Index (AHI)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Harvard School of Dental Medicine</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Harvard School of Dental Medicine</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>
      The study design of this research project involves orthodontic patients registered at the&#xD;
      Harvard School of Dental Medicine who are deemed eligible to undergo orthodontic treatment&#xD;
      and who have been provided with sufficient information to make informed consent to join the&#xD;
      sleep study. These patients will be provided with the Medibyte sleep monitor and instructed&#xD;
      on the proper manner in which it should be set up and worn for the one night study period.&#xD;
      This process will be carried out twice throughout the course of the study, once before any&#xD;
      orthodontic appliance has been cemented and once after the required amount of tooth movement&#xD;
      has been attained with the orthodontic appliance still in place.&#xD;
&#xD;
      The de-identified data from the Medibyte monitor will be downloaded using the Braebon&#xD;
      software and analyzed.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The study design of this research project involves recruiting orthodontic patients registered&#xD;
      at the Harvard School of Dental Medicine who are deemed eligible to undergo orthodontic&#xD;
      treatment and who have been provided with sufficient information to make informed consent to&#xD;
      join the sleep study. The participants will be provided with the Medibyte sleep monitor and&#xD;
      instructed on the proper manner in which it should be set up and worn for the one or two&#xD;
      night study period. The purpose of the Medibyte monitor is solely to provide a calibrated&#xD;
      value of AHI. The Medibyte monitor will not be utilized for investigations and/or treat,&#xD;
      cure, mitigate a medical condition. This process will be carried out twice throughout the&#xD;
      course of the study, once before any orthodontic appliance has been cemented and once after&#xD;
      the required amount of tooth movement has been attained with the orthodontic appliance still&#xD;
      in place.&#xD;
&#xD;
      The de-identified data from the Medibyte monitor will be downloaded using the Braebon&#xD;
      software and analyzed providing a baseline value and post orthodontic movement AHI value.&#xD;
      Additionally the patients arch width, length and other orthodontic measurements will also be&#xD;
      taken both from their 3-D dental models and also their 2-D lateral cephalogram x-ray all of&#xD;
      which are part of the routine orthodontic records (the x-rays will be taken regardless of the&#xD;
      patients participation in the study since they are a required component of the orthodontic&#xD;
      records taken at HSDM). The values obtained from the patients casts, lateral cephalogram and&#xD;
      Medibyte AHI values will be analyzed both pre-orthodontic appliance cementation and also post&#xD;
      tooth movement. The changes, if any, in the dental parameters as compared with the AHI values&#xD;
      will allow the investigation of the orthodontic effects of expanding the maxilla, moving the&#xD;
      front teeth either forwards or backwards which in effect cause changes to the airway and its&#xD;
      effect on AHI values during sleep. In addition to the measurements taken intra-orally,&#xD;
      surveys will also be undertaken to study any changes the patients may experience in their&#xD;
      sleep and quality of life. If the Medibyte shows a severe reading for obstructive sleep&#xD;
      apnea, these patients will then be referred to a sleep specialist for further more conclusive&#xD;
      testing.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">January 20, 2017</start_date>
  <completion_date type="Anticipated">June 10, 2019</completion_date>
  <primary_completion_date type="Anticipated">May 10, 2019</primary_completion_date>
  <study_type>Observational [Patient Registry]</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>
  <target_duration>1 Year</target_duration>
  <primary_outcome>
    <measure>Relationship between dental movements and AHI</measure>
    <time_frame>2 Year</time_frame>
    <description>This outcome aims to measure any changes in the dental measurements such as arch length, arch perimeter, inter-canine and inter-molar changes on the AHI value.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Relationship between skeletal changes and AHI</measure>
    <time_frame>2 Year</time_frame>
    <description>This outcome aims to measure any changes in the skeletal changes such as SNA, SNB, ANB etc. as measured by the lateral cephalogram and any changes in the AHI</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Relationship between airway cephalometric changes and AHI</measure>
    <time_frame>2 Year</time_frame>
    <description>This outcome aims to measure any changes in the airway cephalometric measurements such as the upper/middle/superior airway space etc. and the AHI</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Relationship between the changes in the reported quality of life measurements and the AHI</measure>
    <time_frame>2 Year</time_frame>
    <description>This outcome aims to measure any changes in the reported quality of life measurements as measured by questionnaires such as conners, epworth, pediatric quality of life and pediatric sleep quesitonnaire and the AHI vale.</description>
  </secondary_outcome>
  <enrollment type="Anticipated">66</enrollment>
  <condition>Obstructive Sleep Apnea</condition>
  <condition>Orthodontic Tooth Movement</condition>
  <condition>Apnea</condition>
  <condition>Sleep Disordered Breathing</condition>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Medibyte Portable Monitor</intervention_name>
    <description>Patients will be provided with the portable monitor in order to measure their apnea/hypopnea index.</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        The study population will include patients already registered at the Harvard School of&#xD;
        Dental Medicine department of Orthodontics. Informed consent will be obtained before the&#xD;
        questionnaires and portable monitor will be provided.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Adults/children undergoing orthodontic care at HSDM&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients already begun orthodontic therapy&#xD;
&#xD;
          -  Patients obtaining orthognathic surgery&#xD;
&#xD;
          -  Patients with high index of care need- have hypercapnia, hypoventilation, allergies or&#xD;
             nose blockages&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>8 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Shaima Tabari</last_name>
    <phone>415-851-0166</phone>
    <email>shaima_tabari@hsdm.harvard.edu</email>
  </overall_contact>
  <location>
    <facility>
      <name>Harvard School of Dental Medicine</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02115</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Shaima Tabari</last_name>
      <phone>415-851-0166</phone>
      <email>shima_tabari@hsdm.harvard.edu</email>
    </contact>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>September 2018</verification_date>
  <study_first_submitted>September 13, 2017</study_first_submitted>
  <study_first_submitted_qc>September 29, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">October 2, 2017</study_first_posted>
  <last_update_submitted>September 10, 2018</last_update_submitted>
  <last_update_submitted_qc>September 10, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">September 11, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Harvard School of Dental Medicine</investigator_affiliation>
    <investigator_full_name>Dr. Shaima Tabari</investigator_full_name>
    <investigator_title>Investigator</investigator_title>
  </responsible_party>
  <keyword>Obstructive Sleep Apnea</keyword>
  <keyword>Orthodontics</keyword>
  <keyword>Tooth Movement</keyword>
  <keyword>Medibyte</keyword>
  <keyword>Apnea</keyword>
  <keyword>Hypopnea</keyword>
  <keyword>Sleep</keyword>
  <keyword>Disturbed Breathing</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>Respiratory Aspiration</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/NCT03299023
org study id: R8-1648
nct id: NCT03299023
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The study design of this research project involves orthodontic patients registered at the
      Harvard School of Dental Medicine who are deemed eligible to undergo orthodontic treatment
      and who have been provided with sufficient information to make informed consent to join the
      sleep study. These patients will be provided with the Medibyte sleep monitor and instructed
      on the proper manner in which it should be set up and worn for the one night study period.
      This process will be carried out twice throughout the course of the study, once before any
      orthodontic appliance has been cemented and once after the required amount of tooth movement
      has been attained with the orthodontic appliance still in place.

      The de-identified data from the Medibyte monitor will be downloaded using the Braebon
      software and analyzed.
The study design of this research project involves recruiting orthodontic patients registered
      at the Harvard School of Dental Medicine who are deemed eligible to undergo orthodontic
      treatment and who have been provided with sufficient information to make informed consent to
      join the sleep study. The participants will be provided with the Medibyte sleep monitor and
      instructed on the proper manner in which it should be set up and worn for the one or two
      night study period. The purpose of the Medibyte monitor is solely to provide a calibrated
      value of AHI. The Medibyte monitor will not be utilized for investigations and/or treat,
      cure, mitigate a medical condition. This process will be carried out twice throughout the
      course of the study, once before any orthodontic appliance has been cemented and once after
      the required amount of tooth movement has been attained with the orthodontic appliance still
      in place.

      The de-identified data from the Medibyte monitor will be downloaded using the Braebon
      software and analyzed providing a baseline value and post orthodontic movement AHI value.
      Additionally the patients arch width, length and other orthodontic measurements will also be
      taken both from their 3-D dental models and also their 2-D lateral cephalogram x-ray all of
      which are part of the routine orthodontic records (the x-rays will be taken regardless of the
      patients participation in the study since they are a required component of the orthodontic
      records taken at HSDM). The values obtained from the patients casts, lateral cephalogram and
      Medibyte AHI values will be analyzed both pre-orthodontic appliance cementation and also post
      tooth movement. The changes, if any, in the dental parameters as compared with the AHI values
      will allow the investigation of the orthodontic effects of expanding the maxilla, moving the
      front teeth either forwards or backwards which in effect cause changes to the airway and its
      effect on AHI values during sleep. In addition to the measurements taken intra-orally,
      surveys will also be undertaken to study any changes the patients may experience in their
      sleep and quality of life. If the Medibyte shows a severe reading for obstructive sleep
      apnea, these patients will then be referred to a sleep specialist for further more conclusive
      testing.
observational model: Cohort
time perspective: Prospective
measure: Relationship between dental movements and AHI
time frame: 2 Year
description: This outcome aims to measure any changes in the dental measurements such as arch length, arch perimeter, inter-canine and inter-molar changes on the AHI value.
measure: Relationship between skeletal changes and AHI
time frame: 2 Year
description: This outcome aims to measure any changes in the skeletal changes such as SNA, SNB, ANB etc. as measured by the lateral cephalogram and any changes in the AHI
measure: Relationship between airway cephalometric changes and AHI
time frame: 2 Year
description: This outcome aims to measure any changes in the airway cephalometric measurements such as the upper/middle/superior airway space etc. and the AHI
measure: Relationship between the changes in the reported quality of life measurements and the AHI
time frame: 2 Year
description: This outcome aims to measure any changes in the reported quality of life measurements as measured by questionnaires such as conners, epworth, pediatric quality of life and pediatric sleep quesitonnaire and the AHI vale.
intervention type: Other
intervention name: Medibyte Portable Monitor
description: Patients will be provided with the portable monitor in order to measure their apnea/hypopnea index.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 8 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Shaima Tabari
phone: 415-851-0166
email: shaima_tabari@hsdm.harvard.edu
facility: 
status: Recruiting
contact: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Harvard School of Dental Medicine
investigator full name: Dr. Shaima Tabari
investigator title: Investigator
mesh term: Apnea
mesh term: Sleep Apnea Syndromes
mesh term: Sleep Apnea, Obstructive
mesh term: Respiratory Aspiration
sharing ipd: No