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Completed

NCT Number: NCT03810248

Association Between Obstructive Sleep Apnea and Bruxism

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).

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Key information

Age range

20 year–60 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Federal University of Pelotas

Pelotas, Rio Grande do Sul, 96015-560, Brazil

About this study

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)".

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Tabulation of polysomnographic report related to sleep efficiency

    Time frame: 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

    Time frame: 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)

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Federal University of Pelotas

Other

Registry information

Official study title

Association Between Obstructive Sleep Apnea and Bruxism: A Retrospective Study

Important dates

Study start
2019
Primary completion
2021
Study completion
2022
First posted
Jan 18, 2019
Registry last updated
Mar 16, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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