<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/NCT03825237</url>
  </required_header>
  <id_info>
    <org_study_id>FUPelotas3</org_study_id>
    <nct_id>NCT03825237</nct_id>
  </id_info>
  <brief_title>Sleep Architecture and Factors Associated With Definitive Diagnosis of Sleep Bruxism</brief_title>
  <official_title>Sleep Architecture and Factors Associated With Definitive Diagnosis of Sleep Bruxism: a Case-control 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>
      This case-control study will evaluates the association between the definitive sleep bruxism&#xD;
      diagnosis by gold-standard polysomnography examination obtained at Pelotas Sleep Institute&#xD;
      and the sociodemographic, occupational, clinical conditions, sleep quality, sleep structure&#xD;
      and Epworth sleepiness scale variables.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Currently, as sleep and awake bruxism are generally considered as different behaviours&#xD;
      observed during sleep and wakefulness, respectively, the single definition for bruxism is&#xD;
      recommended be &quot;retired&quot; in favour of 2 separate definitions. In this sense, the sleep&#xD;
      bruxism is a masticatory muscle activity during sleep that is characterised as rhythmic&#xD;
      (phasic) or non-rhythmic (tonic) and is not a movement disorder or a sleep disorder in&#xD;
      otherwise healthy individuals .The diagnosis of sleep bruxism often is challenging and&#xD;
      despite the use of questionnaires, clinical exams and portable devices, based on current&#xD;
      knowledge, the polysomnography with audio-video recordings emerges as the gold-standard&#xD;
      criteria for a definite sleep bruxism diagnosis.&#xD;
&#xD;
      Included on the questionnaire there is a registration form, which contains: Sociodemographic:&#xD;
      self-reported ethnicity, marital status, education level; Occupational: individuals were&#xD;
      asked about work outside home, working hours; Clinical condition: body mass index, smoking;&#xD;
      alcohol consumption; use of sleeping pills.&#xD;
&#xD;
      Sleep Quality, was evaluated with the following questions: Sleep behavioral, how long does it&#xD;
      take to sleep; restless sleep; nightmares; heartburn, obstructive sleep apnea by&#xD;
      polysomnography. Bedtime, sleep time. Waking during the night, insomnia. Morning wake up,&#xD;
      headache on waking; Lastly, Sleep structure data: sleep onset latency, rapid eye movement,&#xD;
      sleep latency, wake time after sleep onset, total sleep time, sleep efficiency, non-rapid eye&#xD;
      movement, sleep time in stages N1, N2, and N3, REM sleep time, arousal, arousal per hour,&#xD;
      respiratory disturbance index, apnea-hypopnea index; and Epworth Sleepiness Scale.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 1, 2018</start_date>
  <completion_date type="Actual">November 15, 2018</completion_date>
  <primary_completion_date type="Actual">July 24, 2018</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Sleep Bruxism</measure>
    <time_frame>4 months</time_frame>
    <description>Patients included in the study received diagnosis of SB by polysomnography exams. The data were obtained from polysomnography records in which masseter electromyography (EMG) burst was detected based on a predefined EMG threshold (20% of maximal voluntary tooth clenching task). Right masseter EMG bursts exceeding 0.25 second in duration were selected for oromotor activity scoring according to published criteria. Oromotor episodes separated by 3-second intervals were recognized as rhythmic masticatory muscle activity (RMMA) if they corresponded to 1 of the 3 following patterns: phasic (3 or more EMG bursts, each lasting 0.25 to 2 seconds), tonic (1 EMG burst lasting more than 2 seconds), or mixed (both burst types) episodes. EMG bursts were considered within the same RMMA episode if the interval between them was shorter than 2 seconds. Participants had SB diagnosed by polysomnography (PSG) if the RMMA index was greater than 2 episodes per hour of sleep.</description>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">116</enrollment>
  <condition>Sleep Bruxism, Adult</condition>
  <arm_group>
    <arm_group_label>With sleep bruxism by polysomnography</arm_group_label>
    <description>Adults (20 to 60 years) and elderly (&gt; 60 years), (WHO-World Health Organization, 2015) who had undergone polysomnography (PSG) from January 2015 to December 2017 were assessed. All self-reports and PSG exams were included and reviewed. The participants were excluded if they presented with a history of neurological or degenerative disorders, and any objection to take the polysomnography test.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Without sleep bruxism by polysomnography</arm_group_label>
    <description>Adults (20 to 60 years) and elderly (&gt; 60 years), (WHO-World Health Organization, 2015) who had undergone polysomnography (PSG) from January 2015 to December 2017 were assessed. All self-reports and PSG exams were included and reviewed. The participants were excluded if they presented with a history of neurological or degenerative disorders, and any objection to take the polysomnography test.</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Polysomnography</intervention_name>
    <description>The polysomnography (referred to as type I) allows assessing several sleep physiologic parameters (eg, EEG, electrooculogram, electromyogram, electrocardiogram, airflow, respiratory effort, oxygen saturation), whereas audio-video recording enables documenting tooth-grinding sounds and distinguishing between rhythmic masticatory muscle activity (RMMA) and orofacial (eg, swallowing) and other muscular activity (eg, head movements) during sleep. Based on the RMMA index (number of episodes per hour of sleep), sleep bruxism is diagnosed when RMMA episodes are greater than or equal to 2 (low-frequency SB, mild bruxism) or RMMA episodes are greater than or equal to 4 (high-frequency SB, severe bruxism)</description>
    <arm_group_label>With sleep bruxism by polysomnography</arm_group_label>
    <arm_group_label>Without sleep bruxism by polysomnography</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Individuals who are in the adult and elderly age group and who seek or are referred to the&#xD;
        Pelotas Sleep Institute for polysomnography in the period from January 2015 to December&#xD;
        2017 were assessed.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-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 were undergone to polysomnography (PSG) at the Pelotas Sleep&#xD;
             Institute (PSI);&#xD;
&#xD;
          -  Adequate cognitive capacity to understand and answer the questionnaire.&#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>90 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>
  <reference>
    <citation>Lobbezoo F, Ahlberg J, Raphael KG, Wetselaar P, Glaros AG, Kato T, Santiago V, Winocur E, De Laat A, De Leeuw R, Koyano K, Lavigne GJ, Svensson P, Manfredini D. International consensus on the assessment of bruxism: Report of a work in progress. J Oral Rehabil. 2018 Nov;45(11):837-844. doi: 10.1111/joor.12663. Epub 2018 Jun 21.</citation>
    <PMID>29926505</PMID>
  </reference>
  <reference>
    <citation>Lavigne GJ, Rompre PH, Montplaisir JY. Sleep bruxism: validity of clinical research diagnostic criteria in a controlled polysomnographic study. J Dent Res. 1996 Jan;75(1):546-52. doi: 10.1177/00220345960750010601.</citation>
    <PMID>8655758</PMID>
  </reference>
  <reference>
    <citation>Casett E, Reus JC, Stuginski-Barbosa J, Porporatti AL, Carra MC, Peres MA, de Luca Canto G, Manfredini D. Validity of different tools to assess sleep bruxism: a meta-analysis. J Oral Rehabil. 2017 Sep;44(9):722-734. doi: 10.1111/joor.12520. Epub 2017 Jun 5.</citation>
    <PMID>28477392</PMID>
  </reference>
  <reference>
    <citation>Palinkas M, De Luca Canto G, Rodrigues LA, Bataglion C, Siessere S, Semprini M, Regalo SC. Comparative Capabilities of Clinical Assessment, Diagnostic Criteria, and Polysomnography in Detecting Sleep Bruxism. J Clin Sleep Med. 2015 Nov 15;11(11):1319-25. doi: 10.5664/jcsm.5196.</citation>
    <PMID>26235152</PMID>
  </reference>
  <verification_date>June 2019</verification_date>
  <study_first_submitted>November 19, 2018</study_first_submitted>
  <study_first_submitted_qc>January 30, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 31, 2019</study_first_posted>
  <last_update_submitted>July 4, 2019</last_update_submitted>
  <last_update_submitted_qc>July 4, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">July 8, 2019</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>diagnostic</keyword>
  <keyword>polysomnography</keyword>
  <keyword>sleep architecture</keyword>
  <keyword>sleep bruxism</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>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT03825237
org study id: FUPelotas3
nct id: NCT03825237
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
This case-control study will evaluates the association between the definitive sleep bruxism
      diagnosis by gold-standard polysomnography examination obtained at Pelotas Sleep Institute
      and the sociodemographic, occupational, clinical conditions, sleep quality, sleep structure
      and Epworth sleepiness scale variables.
Currently, as sleep and awake bruxism are generally considered as different behaviours
      observed during sleep and wakefulness, respectively, the single definition for bruxism is
      recommended be "retired" in favour of 2 separate definitions. In this sense, the sleep
      bruxism is a masticatory muscle activity during sleep that is characterised as rhythmic
      (phasic) or non-rhythmic (tonic) and is not a movement disorder or a sleep disorder in
      otherwise healthy individuals .The diagnosis of sleep bruxism often is challenging and
      despite the use of questionnaires, clinical exams and portable devices, based on current
      knowledge, the polysomnography with audio-video recordings emerges as the gold-standard
      criteria for a definite sleep bruxism diagnosis.

      Included on the questionnaire there is a registration form, which contains: Sociodemographic:
      self-reported ethnicity, marital status, education level; Occupational: individuals were
      asked about work outside home, working hours; Clinical condition: body mass index, smoking;
      alcohol consumption; use of sleeping pills.

      Sleep Quality, was evaluated with the following questions: Sleep behavioral, how long does it
      take to sleep; restless sleep; nightmares; heartburn, obstructive sleep apnea by
      polysomnography. Bedtime, sleep time. Waking during the night, insomnia. Morning wake up,
      headache on waking; Lastly, Sleep structure data: sleep onset latency, rapid eye movement,
      sleep latency, wake time after sleep onset, total sleep time, sleep efficiency, non-rapid eye
      movement, sleep time in stages N1, N2, and N3, REM sleep time, arousal, arousal per hour,
      respiratory disturbance index, apnea-hypopnea index; and Epworth Sleepiness Scale.
observational model: Case-Control
time perspective: Cross-Sectional
measure: Sleep Bruxism
time frame: 4 months
description: Patients included in the study received diagnosis of SB by polysomnography exams. The data were obtained from polysomnography records in which masseter electromyography (EMG) burst was detected based on a predefined EMG threshold (20% of maximal voluntary tooth clenching task). Right masseter EMG bursts exceeding 0.25 second in duration were selected for oromotor activity scoring according to published criteria. Oromotor episodes separated by 3-second intervals were recognized as rhythmic masticatory muscle activity (RMMA) if they corresponded to 1 of the 3 following patterns: phasic (3 or more EMG bursts, each lasting 0.25 to 2 seconds), tonic (1 EMG burst lasting more than 2 seconds), or mixed (both burst types) episodes. EMG bursts were considered within the same RMMA episode if the interval between them was shorter than 2 seconds. Participants had SB diagnosed by polysomnography (PSG) if the RMMA index was greater than 2 episodes per hour of sleep.
arm group label: With sleep bruxism by polysomnography
description: Adults (20 to 60 years) and elderly (> 60 years), (WHO-World Health Organization, 2015) who had undergone polysomnography (PSG) from January 2015 to December 2017 were assessed. All self-reports and PSG exams were included and reviewed. The participants were excluded if they presented with a history of neurological or degenerative disorders, and any objection to take the polysomnography test.
arm group label: Without sleep bruxism by polysomnography
description: Adults (20 to 60 years) and elderly (> 60 years), (WHO-World Health Organization, 2015) who had undergone polysomnography (PSG) from January 2015 to December 2017 were assessed. All self-reports and PSG exams were included and reviewed. The participants were excluded if they presented with a history of neurological or degenerative disorders, and any objection to take the polysomnography test.
intervention type: Diagnostic Test
intervention name: Polysomnography
description: The polysomnography (referred to as type I) allows assessing several sleep physiologic parameters (eg, EEG, electrooculogram, electromyogram, electrocardiogram, airflow, respiratory effort, oxygen saturation), whereas audio-video recording enables documenting tooth-grinding sounds and distinguishing between rhythmic masticatory muscle activity (RMMA) and orofacial (eg, swallowing) and other muscular activity (eg, head movements) during sleep. Based on the RMMA index (number of episodes per hour of sleep), sleep bruxism is diagnosed when RMMA episodes are greater than or equal to 2 (low-frequency SB, mild bruxism) or RMMA episodes are greater than or equal to 4 (high-frequency SB, severe bruxism)
arm group label: With sleep bruxism by polysomnography
arm group label: Without sleep bruxism by polysomnography
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 20 Years
maximum age: 90 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Noéli Boscato, PhD
role: Principal Investigator
affiliation: Federal University of Pelotas
facility: 
country: Brazil
citation: Lobbezoo F, Ahlberg J, Raphael KG, Wetselaar P, Glaros AG, Kato T, Santiago V, Winocur E, De Laat A, De Leeuw R, Koyano K, Lavigne GJ, Svensson P, Manfredini D. International consensus on the assessment of bruxism: Report of a work in progress. J Oral Rehabil. 2018 Nov;45(11):837-844. doi: 10.1111/joor.12663. Epub 2018 Jun 21.
PMID: 29926505
citation: Lavigne GJ, Rompre PH, Montplaisir JY. Sleep bruxism: validity of clinical research diagnostic criteria in a controlled polysomnographic study. J Dent Res. 1996 Jan;75(1):546-52. doi: 10.1177/00220345960750010601.
PMID: 8655758
citation: Casett E, Reus JC, Stuginski-Barbosa J, Porporatti AL, Carra MC, Peres MA, de Luca Canto G, Manfredini D. Validity of different tools to assess sleep bruxism: a meta-analysis. J Oral Rehabil. 2017 Sep;44(9):722-734. doi: 10.1111/joor.12520. Epub 2017 Jun 5.
PMID: 28477392
citation: Palinkas M, De Luca Canto G, Rodrigues LA, Bataglion C, Siessere S, Semprini M, Regalo SC. Comparative Capabilities of Clinical Assessment, Diagnostic Criteria, and Polysomnography in Detecting Sleep Bruxism. J Clin Sleep Med. 2015 Nov 15;11(11):1319-25. doi: 10.5664/jcsm.5196.
PMID: 26235152
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
sharing ipd: Undecided