Association Between Obstructive Sleep Apnea and Bruxism

Obstructive Sleep Apnea Clinical Trial

Official title:

Association Between Obstructive Sleep Apnea and Bruxism: A Retrospective Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03810248
• Other study ID #: FUPelotas 4
• Status: Completed
• Start date: July 17, 2019
• Est. completion date: February 1, 2022

Study information

• Verified date: March 2022
• Source: Federal University of Pelotas
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

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)".

Recruitment information / eligibility

• Status: Completed
• Enrollment: 640
• Est. completion date: February 1, 2022
• Est. primary completion date: September 1, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Apnea
• Bruxism
• Bruxism, Sleep
• Obstructive Sleep Apnea
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive
• Sleep Bruxism

Locations

Country	Name	City	State
Brazil	Federal University of Pelotas	Pelotas	RS

Sponsors (1)

Lead Sponsor	Collaborator
Federal University of Pelotas

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Tabulation of polysomnographic report related to sleep efficiency	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.	The deadline is until May 2020 to have all data collected
Primary	Tabulation of polysomnographic report related to sleep bruxism	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.	The deadline is until May 2020 to have all data collected
Primary	Tabulation of polysomnographic report related to obstructive sleep apnea syndrome (SAOS)	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.	The deadline is until May 2020 to have all data collected