<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/NCT03810248</url>
  </required_header>
  <id_info>
    <org_study_id>FUPelotas 4</org_study_id>
    <nct_id>NCT03810248</nct_id>
  </id_info>
  <brief_title>Association Between Obstructive Sleep Apnea and Bruxism</brief_title>
  <official_title>Association Between Obstructive Sleep Apnea and Bruxism: A Retrospective Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Federal University of Pelotas</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Federal University of Pelotas</source>
  <oversight_info>
    <has_dmc>Yes</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 objective of this retrospective observational study will be to investigate the between&#xD;
      the Obstructive Sleep Apnea Syndrome (OSAS) and Sleep Bruxism (SB), in individuals diagnosed&#xD;
      through polysomnography (PSG).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The SB and OSAS are sleep disorders with great importance for dentistry. The OSAS is&#xD;
      characterized by partial or total obstruction of the upper airways. SB is defined as a&#xD;
      repetitive activity of the mandibular musculature characterized by the tightening or grinding&#xD;
      of the teeth and/or by the retrusion or propulsion of the mandible. This study retrospective&#xD;
      observational will be evaluation to investigate the association between OSAS and SB. Data&#xD;
      from PSG and medical records (n=640) will be collected from January 2012 to July 2018 at&#xD;
      &quot;Instituto do Sono de Pelotas (ISP)&quot;.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 17, 2019</start_date>
  <completion_date type="Actual">February 1, 2022</completion_date>
  <primary_completion_date type="Actual">September 1, 2021</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>Tabulation of polysomnographic report related to sleep efficiency</measure>
    <time_frame>The deadline is until May 2020 to have all data collected</time_frame>
    <description>These data are provided from the medical report generated in the polysomnography examination in%. Values above 85% will be classified as good sleep efficiency, and values below 85% will be classified as poor sleep efficiency. These polysomnographic exams were performed at the &quot;Sleep Institute of Pelotas (ISP)&quot; from January 2012 to July 2018.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Tabulation of polysomnographic report related to sleep bruxism</measure>
    <time_frame>The deadline is until May 2020 to have all data collected</time_frame>
    <description>These data are provided from the medical report generated in the polysomnography examination in the presence or absence of sleep bruxism. These polysomnographic exams were performed at the &quot;Sleep Institute of Pelotas (ISP)&quot; from January 2012 to July 2018.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Tabulation of polysomnographic report related to obstructive sleep apnea syndrome (SAOS)</measure>
    <time_frame>The deadline is until May 2020 to have all data collected</time_frame>
    <description>OSAS is classified according to its severity, which varies according to the number of apnea and hypopnea indexes per hour (AHI), 15; moderate of 16-30, and recorded the first upper 31 episodes. These data are provided from the medical report generated in the polysomnography. These polysomnographic exams were performed at the &quot;Sleep Institute of Pelotas (ISP)&quot; from January 2012 to July 2018.</description>
  </primary_outcome>
  <enrollment type="Actual">640</enrollment>
  <condition>Bruxism, Sleep</condition>
  <condition>Obstructive Sleep Apnea</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Individuals who have undergone polysomnography at the Instituto do Sono de Pelotas (ISP)&#xD;
        between March 2012 and July 2018, who meet inclusion criteria.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Adults (aged 20 to 60 years) and elderly (aged &gt; 60 years) (WHO-World Health&#xD;
             Organization, 2015) who was undergone PSG at the &quot;Instituto do Sono de Pelotas (ISP)&quot;;&#xD;
&#xD;
          -  Have completed all the respective PSG reports.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        •Those which the participants were unable to answer the questionnaires and who presented a&#xD;
        history of epilepsy that could interfere in the results of PSG.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Noéli Boscato, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Federal University of Pelotas</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Federal University of Pelotas</name>
      <address>
        <city>Pelotas</city>
        <state>RS</state>
        <zip>96015-560</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Brazil</country>
  </location_countries>
  <verification_date>March 2022</verification_date>
  <study_first_submitted>November 6, 2018</study_first_submitted>
  <study_first_submitted_qc>January 16, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 18, 2019</study_first_posted>
  <last_update_submitted>March 14, 2022</last_update_submitted>
  <last_update_submitted_qc>March 14, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">March 16, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Federal University of Pelotas</investigator_affiliation>
    <investigator_full_name>Noéli Boscato, PhD</investigator_full_name>
    <investigator_title>Associate Professor</investigator_title>
  </responsible_party>
  <keyword>sleep bruxism</keyword>
  <keyword>polisomnography</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Bruxism</mesh_term>
    <mesh_term>Sleep Bruxism</mesh_term>
    <mesh_term>Apnea</mesh_term>
    <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/NCT03810248
org study id: FUPelotas 4
nct id: NCT03810248
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The objective of this retrospective observational study will be to investigate the between
      the Obstructive Sleep Apnea Syndrome (OSAS) and Sleep Bruxism (SB), in individuals diagnosed
      through polysomnography (PSG).
The SB and OSAS are sleep disorders with great importance for dentistry. The OSAS is
      characterized by partial or total obstruction of the upper airways. SB is defined as a
      repetitive activity of the mandibular musculature characterized by the tightening or grinding
      of the teeth and/or by the retrusion or propulsion of the mandible. This study retrospective
      observational will be evaluation to investigate the association between OSAS and SB. Data
      from PSG and medical records (n=640) will be collected from January 2012 to July 2018 at
      "Instituto do Sono de Pelotas (ISP)".
observational model: Cohort
time perspective: Retrospective
measure: Tabulation of polysomnographic report related to sleep efficiency
time frame: The deadline is until May 2020 to have all data collected
description: These data are provided from the medical report generated in the polysomnography examination in%. Values above 85% will be classified as good sleep efficiency, and values below 85% will be classified as poor sleep efficiency. These polysomnographic exams were performed at the "Sleep Institute of Pelotas (ISP)" from January 2012 to July 2018.
measure: Tabulation of polysomnographic report related to sleep bruxism
time frame: The deadline is until May 2020 to have all data collected
description: These data are provided from the medical report generated in the polysomnography examination in the presence or absence of sleep bruxism. These polysomnographic exams were performed at the "Sleep Institute of Pelotas (ISP)" from January 2012 to July 2018.
measure: Tabulation of polysomnographic report related to obstructive sleep apnea syndrome (SAOS)
time frame: The deadline is until May 2020 to have all data collected
description: OSAS is classified according to its severity, which varies according to the number of apnea and hypopnea indexes per hour (AHI), 15; moderate of 16-30, and recorded the first upper 31 episodes. These data are provided from the medical report generated in the polysomnography. These polysomnographic exams were performed at the "Sleep Institute of Pelotas (ISP)" from January 2012 to July 2018.
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 20 Years
maximum age: 60 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Noéli Boscato, PhD
role: Principal Investigator
affiliation: Federal University of Pelotas
facility: 
country: Brazil
responsible party type: Principal Investigator
investigator affiliation: Federal University of Pelotas
investigator full name: Noéli Boscato, PhD
investigator title: Associate Professor
mesh term: Bruxism
mesh term: Sleep Bruxism
mesh term: Apnea
mesh term: Sleep Apnea Syndromes
mesh term: Sleep Apnea, Obstructive