<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/NCT03766477</url>
  </required_header>
  <id_info>
    <org_study_id>FUPelotas2</org_study_id>
    <nct_id>NCT03766477</nct_id>
  </id_info>
  <brief_title>Aspects Associated With Sleep Quality</brief_title>
  <official_title>Aspects Associated With Bruxism and Sleep Quality</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>
      Evaluate the correlation among the diagnostics of sleep bruxism and sleep quality obtained&#xD;
      from the use of smartphone application (APP-Sleep Cycle®), PSG and questionnaires (Pittsburgh&#xD;
      Sleep Quality Index-IQSP and Johansson).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study will evaluate the correlation between sleep bruxism and sleep quality diagnoses&#xD;
      obtained using the application of the smartphone (APP-Sleep Cycle®), polysomnography and&#xD;
      questionnaires (Pittsburgh Sleep Quality Index-IQSP and Johansson). Subjects (n = 40) between&#xD;
      19 and 60 years old will be submitted to polysomnography from January to December 2019. The&#xD;
      questionnaires will be applied before the polysomnography, and the APP will be used together&#xD;
      with the polysomnography. The data will be tabulated and a descriptive statistical analysis&#xD;
      performed. Specific statistical tests will be determined after preliminary analysis of the&#xD;
      data (α = 0.05).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 1, 2019</start_date>
  <completion_date type="Actual">January 1, 2022</completion_date>
  <primary_completion_date type="Actual">April 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>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Data Collect on Sleep Quality with ISQP quastionario.</measure>
    <time_frame>4 months after study start</time_frame>
    <description>Sleep quality data will be collected from the ISQP quastionario</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Data Collect on Sleep Quality with the APP</measure>
    <time_frame>4 months after study start</time_frame>
    <description>The sleep quality data will be collected in the APP along with the polysomnography exam, and the efficiency of the sleep is measured (god &gt;80% or bad &lt;80%).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Data Collect on Sleep Quality with polysomnography exam</measure>
    <time_frame>4 months after study start</time_frame>
    <description>The sleep quality data will be collected in the polysomnography exam along with the APP, and the efficiency of the sleep is measured (god &gt;80% or bad &lt;80%).</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">40</enrollment>
  <condition>Sleep Bruxism</condition>
  <arm_group>
    <arm_group_label>Individuals with sleep bruxism</arm_group_label>
    <description>Individuals with sleep bruxism evaluated in three different methods regarding their sleep quality:&#xD;
Pittsburgh Sleep Quality Index (IQSP) and Johansson&#xD;
Smartphone APP&#xD;
Polysomnography</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Pittsburgh Sleep Quality Index (IQSP) and Johansson</intervention_name>
    <description>All participants will to answer the Pittsburgh Sleep Quality Index (IQSP) and Johansson questionnaires before polysomnography examination and use of APP.</description>
    <arm_group_label>Individuals with sleep bruxism</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Smartphone APP</intervention_name>
    <description>All study participants will use a smartphone application (APP), which will be made available by the researchers, at the same time as the polysomnography exam.</description>
    <arm_group_label>Individuals with sleep bruxism</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Polysomnography</intervention_name>
    <description>All participants slept for one night in a sleep laboratory for PSG recording. The data will be confirmed by an otorhinolaryngology certified by the Brazilian Association of Sleep Disorders</description>
    <arm_group_label>Individuals with sleep bruxism</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        All adults (aged 20 to 60 years) and elderly (aged &gt; 60 years) who had undergone PSG at the&#xD;
        Pelotas Sleep Institute (ISP), a private medical out patients clinic, from January to&#xD;
        December 2019, will be invited to participate in the study.&#xD;
&#xD;
        Eligibility criteria includ adequate cognitive capacity to understand and answer the&#xD;
        questionnaire. Written consent will be given by all participants who agreed to participate&#xD;
        in the study.&#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 will be undergone PSG at the Pelotas Sleep Institute (ISP);&#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>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>Noéli Boscato</name>
      <address>
        <city>Pelotas</city>
        <state>Rio Grande Do Sul</state>
        <zip>96015560</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Noéli Boscato</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>December 4, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 6, 2018</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>Sleep</keyword>
  <keyword>Sleep hygiene</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>
  <!-- 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/NCT03766477
org study id: FUPelotas2
nct id: NCT03766477
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Evaluate the correlation among the diagnostics of sleep bruxism and sleep quality obtained
      from the use of smartphone application (APP-Sleep Cycle®), PSG and questionnaires (Pittsburgh
      Sleep Quality Index-IQSP and Johansson).
This study will evaluate the correlation between sleep bruxism and sleep quality diagnoses
      obtained using the application of the smartphone (APP-Sleep Cycle®), polysomnography and
      questionnaires (Pittsburgh Sleep Quality Index-IQSP and Johansson). Subjects (n = 40) between
      19 and 60 years old will be submitted to polysomnography from January to December 2019. The
      questionnaires will be applied before the polysomnography, and the APP will be used together
      with the polysomnography. The data will be tabulated and a descriptive statistical analysis
      performed. Specific statistical tests will be determined after preliminary analysis of the
      data (α = 0.05).
observational model: Cohort
time perspective: Prospective
measure: Data Collect on Sleep Quality with ISQP quastionario.
time frame: 4 months after study start
description: Sleep quality data will be collected from the ISQP quastionario
measure: Data Collect on Sleep Quality with the APP
time frame: 4 months after study start
description: The sleep quality data will be collected in the APP along with the polysomnography exam, and the efficiency of the sleep is measured (god >80% or bad <80%).
measure: Data Collect on Sleep Quality with polysomnography exam
time frame: 4 months after study start
description: The sleep quality data will be collected in the polysomnography exam along with the APP, and the efficiency of the sleep is measured (god >80% or bad <80%).
arm group label: Individuals with sleep bruxism
description: Individuals with sleep bruxism evaluated in three different methods regarding their sleep quality:
Pittsburgh Sleep Quality Index (IQSP) and Johansson
Smartphone APP
Polysomnography
intervention type: Diagnostic Test
intervention name: Pittsburgh Sleep Quality Index (IQSP) and Johansson
description: All participants will to answer the Pittsburgh Sleep Quality Index (IQSP) and Johansson questionnaires before polysomnography examination and use of APP.
arm group label: Individuals with sleep bruxism
intervention type: Diagnostic Test
intervention name: Smartphone APP
description: All study participants will use a smartphone application (APP), which will be made available by the researchers, at the same time as the polysomnography exam.
arm group label: Individuals with sleep bruxism
intervention type: Diagnostic Test
intervention name: Polysomnography
description: All participants slept for one night in a sleep laboratory for PSG recording. The data will be confirmed by an otorhinolaryngology certified by the Brazilian Association of Sleep Disorders
arm group label: Individuals with sleep bruxism
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: 
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