NCT03810248

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
640

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2019

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 6, 2018

Completed
2 months until next milestone

First Posted

Study publicly available on registry

January 18, 2019

Completed
6 months until next milestone

Study Start

First participant enrolled

July 17, 2019

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2021

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2022

Completed
Last Updated

March 16, 2022

Status Verified

March 1, 2022

Enrollment Period

2.1 years

First QC Date

November 6, 2018

Last Update Submit

March 14, 2022

Conditions

Keywords

sleep bruxismpolisomnography

Outcome Measures

Primary Outcomes (3)

  • 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

  • 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

  • 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

Eligibility Criteria

Age20 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodProbability 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.

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Federal University of Pelotas

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

Location

MeSH Terms

Conditions

Sleep BruxismSleep Apnea, Obstructive

Condition Hierarchy (Ancestors)

BruxismTooth DiseasesStomatognathic DiseasesParasomniasSleep Wake DisordersNervous System DiseasesMental DisordersSleep Apnea SyndromesApneaRespiration DisordersRespiratory Tract DiseasesSleep Disorders, IntrinsicDyssomnias

Study Officials

  • Noéli Boscato, PhD

    Federal University of Pelotas

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

November 6, 2018

First Posted

January 18, 2019

Study Start

July 17, 2019

Primary Completion

September 1, 2021

Study Completion

February 1, 2022

Last Updated

March 16, 2022

Record last verified: 2022-03

Locations