Association Between Obstructive Sleep Apnea and Bruxism

Sponsor
Federal University of Pelotas (Other)
Overall Status
Completed
CT.gov ID
NCT03810248
Collaborator
(none)
640
1
30.6
20.9

Study Details

Study Description

Brief Summary

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).

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    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)".

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    640 participants
    Observational Model:
    Cohort
    Time Perspective:
    Retrospective
    Official Title:
    Association Between Obstructive Sleep Apnea and Bruxism: A Retrospective Study
    Actual Study Start Date :
    Jul 17, 2019
    Actual Primary Completion Date :
    Sep 1, 2021
    Actual Study Completion Date :
    Feb 1, 2022

    Outcome Measures

    Primary Outcome Measures

    1. Tabulation of polysomnographic report related to sleep efficiency [The deadline is until May 2020 to have all data collected]

      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.

    2. Tabulation of polysomnographic report related to sleep bruxism [The deadline is until May 2020 to have all data collected]

      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.

    3. Tabulation of polysomnographic report related to obstructive sleep apnea syndrome (SAOS) [The deadline is until May 2020 to have all data collected]

      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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    20 Years to 60 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:
    • Adults (aged 20 to 60 years) and elderly (aged > 60 years) (WHO-World Health Organization, 2015) who was undergone PSG at the "Instituto do Sono de Pelotas (ISP)";

    • Have completed all the respective PSG reports.

    Exclusion Criteria:

    •Those which the participants were unable to answer the questionnaires and who presented a history of epilepsy that could interfere in the results of PSG.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Federal University of Pelotas Pelotas RS Brazil 96015-560

    Sponsors and Collaborators

    • Federal University of Pelotas

    Investigators

    • Principal Investigator: Noéli Boscato, PhD, Federal University of Pelotas

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Noéli Boscato, PhD, Associate Professor, Federal University of Pelotas
    ClinicalTrials.gov Identifier:
    NCT03810248
    Other Study ID Numbers:
    • FUPelotas 4
    First Posted:
    Jan 18, 2019
    Last Update Posted:
    Mar 16, 2022
    Last Verified:
    Mar 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Noéli Boscato, PhD, Associate Professor, Federal University of Pelotas
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Mar 16, 2022