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Association Between Obstructive Sleep Apnea and Bruxism

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ClinicalTrials.gov Identifier: NCT03810248
Recruitment Status : Recruiting
First Posted : January 18, 2019
Last Update Posted : July 18, 2019
Sponsor:
Information provided by (Responsible Party):
Noéli Boscato, PhD, Federal University of Pelotas

Tracking Information
First Submitted Date November 6, 2018
First Posted Date January 18, 2019
Last Update Posted Date July 18, 2019
Actual Study Start Date July 17, 2019
Estimated Primary Completion Date May 1, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: January 16, 2019)
  • 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.
  • 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.
  • 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.
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT03810248 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Association Between Obstructive Sleep Apnea and Bruxism
Official Title Association Between Obstructive Sleep Apnea and Bruxism: A Retrospective Study
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).
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 Type Observational
Study Design Observational Model: Cohort
Time Perspective: Retrospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population Individuals who have undergone polysomnography at the Instituto do Sono de Pelotas (ISP) between March 2012 and July 2018, who meet inclusion criteria.
Condition
  • Bruxism, Sleep
  • Obstructive Sleep Apnea
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: January 16, 2019)
640
Original Estimated Enrollment Same as current
Estimated Study Completion Date January 1, 2022
Estimated Primary Completion Date May 1, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria

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.

Sex/Gender
Sexes Eligible for Study: All
Ages 20 Years to 60 Years   (Adult)
Accepts Healthy Volunteers Yes
Contacts
Contact: Noéli Boscato, PhD +55 53999530000 noeliboscato@gmail.com
Listed Location Countries Brazil
Removed Location Countries  
 
Administrative Information
NCT Number NCT03810248
Other Study ID Numbers FUPelotas 4
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement Not Provided
Responsible Party Noéli Boscato, PhD, Federal University of Pelotas
Study Sponsor Federal University of Pelotas
Collaborators Not Provided
Investigators
Principal Investigator: Noéli Boscato, PhD Federal University of Pelotas
PRS Account Federal University of Pelotas
Verification Date July 2019